70 BIBLIOGRAPHY

1 Center for Drug Evaluation and Research [CDER] US Food and

Drug Administration [USFDA] Guidance for Industry Bioavailability

and Bioequivalence-Studies for Orally Administered Drug Prodcuts-

General Considerations Revision 1 Mar 2003 1-23

2 Yuvraj Singh Dangi M L Soni and K P Namdeo Highly Variable

drugs Bioequivalence requirements and Regulatory perspectives

Journal of Current Pharmaceutical Research 3[1] 2010 24-28

3 Central Drugs Standard Control Organization Directorate General of

Health Services Government of India Guidelines for Bioavailability

and Bioequivalence-Studies Mar 2005 1-33

4 Brazilian Sanitary Surveillance Agency Guide For Relative

BioavailabilityBioequivalence Tests Resolution - RE 896 Article-1

May 2003

5 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for Industry Food-effect BioavailabilityFed

Bioequivalence studies Dec 2002 1-9

6 Committee for Proprietory Medicinal Products Working Party on

Efficacy of Medicinal Products Note for guidance Investigation of

bioavailability and bioequivalence The European Agency for the

Evaluation of Medicinal Products July 2008 1-29

7 Midha KK Nagai T Bioavailability bioequivalence and

pharmacokinetic studies FIP Bio-international 96 Tokyo Business

center for academic societies Japan 1996

8 World Health Organization Additional guidance for organizations

performing in vivo bioequivalence studies Annex-9 WHO technical

report series 2006 937

9 Saudi Food and Drug Authority Draft bioequivalence requirements

guidelines May 2005 1-41

10 Therapeutic Products Directorate Minister of Health Health Canada

Conduct and analysis of comparative bioavailability studies-Part A

Oral dosage formulations used for systemic effects 1992 1-49

11 Therapeutic Products Directorate Minister of Health Health Canada

Conduct and analysis of comparative bioavailability studies-Part B

Oral Modified Release Formulations 1996 1-129

12 Chow SC Liu JP Design and Analysis of Bioavailability and

Bioequivalence Studies - Revised and Expanded 2nd Edition Marcel

Dekker Inc New York 1992

13 Chow SC and Liu JP Design and analysis of bioavailability and

bioequivalence studies 3rd Edition Chapman HallCRC Press Taylor

amp Francis [New York] 2008

14 Blume H and Midha KK Report of Consensus Meeting Bio-

international rsquo92 Conference on Bioavailability Bioequivalence and

Pharmacokinetic Studies Bad Homburg Germany 20-22 May 1992

Eur J Pharm Sci 1165-171

15 Boddy AW Snikeris FC Kringle RO Wei GCG Oppermann

JA and Midha KK An approach for widening the bioequivalence

acceptance limits in the case of highly variable drugs Pharm Res

1995121865-1868

16 Marzo A Clinical pharmacokinetic registrations file for NDA and

ANDA procedures Pharmacological research Chapter-36 1997 425-

450

17 Therapeutic Products Directorate Minister of Health Health Canada

Discussion paper on Bioequivalence requirements - highly variable

drugs and highly variable drug products issues and options Expert

Advisory Committee on Bioavailability and Bioequivalence [EAC-BB]

Meeting June 26-27 2003

18 Department of Health and Human Services US Food and Drug

Administration Bioavailability and bioequivalence requirements

Drugs for human use Code of federal regulations Title 21 Volume 5

Chapter I Part 32024 Apr 2011

19 Robert P Heaney Factors Influencing the Measurement of

Bioavailability Taking Calcium as a Model J Nutr 131 2001 1344-

1348

20 Westlake WJ Bioavailability and bioequivalence pharmaceutical

formulations In Peace KE [Ed] Biopharmaceu -tical statistics for

drug development Marcell Dekker New York 1988 329-352

21 Investigation of bioavailability and bioequivalence The rules

governing medicinal products in European Community Vol III

addendum-2 1991 149-169

22 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry-waiver of in vivo bioavailability

and bioequivalence studies for immediate-release solid oral dosage

forms based on a biopharmaceutics classification system August

2000 1-13

23 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry-Bioequivalence

recommendations for specific products Jun 2010 1-4

24 Center for Drug Evaluation and Research US Food and Drug

Administration Inspections of clinical facilities and analytical

laboratories conducting bioequivalence studies submitted in ANDAS

Dec 2000 1-5

25 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use General

considerations for clinical trials-E8 ICH triplicate efficacy guidelines

Version-4 Jul 1997 1-13

26 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Structure and

content of clinical study reports-E3 ICH triplicate efficacy guidelines

Version-4 Nov 1995

27 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Guideline for good

clinical practice-E6 [R1] ICH triplicate efficacy guidelines Version-4

June 1996

28 Michael J McGraw Adam N George Shawn P Shearn and Rigel L

Hall editors Principles of Good Clinical Practice Pharmaceutical

Press 1st edition 2010 245-256

29 Central Drugs Standard Control Organization Directorate General of

Health Services Government of India Guide lines on Good clinical

practice 2005

30 World Health Organization Guidelines for GCP for trials on

pharmaceutical products WHO technical report series Annex-3 850

1995 1-35

31 Department of Health and Human Services US Food and Drug

Administration Protection of human subjects Code of federal

regulations Title 21 Volume-1 Chapter- I part 50

32 Department of Health and Human Services US Food and Drug

Administration Institutional review boards Code of federal

regulations Title 21 volume-1 chapter- I part 56

33 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for institutional review boards clinical

investigators and sponsors Exception from Informed Consent

Requirements for Emergency Research July 2006

34 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Investigator responsibilities

protecting the rights safety and welfare of study subjects Oct 2009

35 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Development

safeties update report-E2F ICH Triplicate efficacy guidelines Version

4 Aug 2010

36 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Clinical safety data

management definitions and standards for expedited reporting-E2A

ICH Triplicate efficacy guidelines Version 4 Oct 1994

37 D M Brahankar sunil B Jaiswal Pharmacokinetics Basic

considerations Biopharmaceutics and Pharmacokinetics Vallabh

Prakashan 2008 212-229

38 Center for Drug Evaluation and Research US Food and Drug

Administration ERIn vitroIn vivo correlations Bioavailability and

Bioequivalence Sep 1997

39 D M Brahankar sunil B Jaiswal Invitro-invivo correlation

Bioavailability and Bioequivalence Biopharmaceutics and

Pharmacokinetics A Treatise Vallabh Prakashan 2008 282-305

40 WHO-Research and training in tropical diseases Handbook of good

laboratory practice Quality practices for regulated non-clinical

research and development 2nd edition 2008 9-40

41 Department of Health and Human Services US Food and Drug

Administration Good laboratory practices for nonclinical laboratory

studies Code of federal regulations Title 21 Volume 1 Chapter- I

Part 58

42 Organisation for Economic Co-operation and Development Good

laboratory practice OECD principles and guidance for compliance

monitoring OECD publishing 2005 13-26

43 Jurg PSeiler Good laboratory practice 2nd edition Springer-Verlag

Berlin Heidelberg European Union 2005 59-103

44 Sandy Weinberg Good laboratory practice regulations 3rd edition

revised and expanded Taylor amp Francis e-Library New York 2005

127-148

12 Chow SC Liu JP Design and Analysis of Bioavailability and

Bioequivalence Studies - Revised and Expanded 2nd Edition Marcel

Dekker Inc New York 1992

13 Chow SC and Liu JP Design and analysis of bioavailability and

bioequivalence studies 3rd Edition Chapman HallCRC Press Taylor

amp Francis [New York] 2008

14 Blume H and Midha KK Report of Consensus Meeting Bio-

international rsquo92 Conference on Bioavailability Bioequivalence and

Pharmacokinetic Studies Bad Homburg Germany 20-22 May 1992

Eur J Pharm Sci 1165-171

15 Boddy AW Snikeris FC Kringle RO Wei GCG Oppermann

JA and Midha KK An approach for widening the bioequivalence

acceptance limits in the case of highly variable drugs Pharm Res

1995121865-1868

16 Marzo A Clinical pharmacokinetic registrations file for NDA and

ANDA procedures Pharmacological research Chapter-36 1997 425-

450

17 Therapeutic Products Directorate Minister of Health Health Canada

Discussion paper on Bioequivalence requirements - highly variable

drugs and highly variable drug products issues and options Expert

Advisory Committee on Bioavailability and Bioequivalence [EAC-BB]

Meeting June 26-27 2003

18 Department of Health and Human Services US Food and Drug

Administration Bioavailability and bioequivalence requirements

Drugs for human use Code of federal regulations Title 21 Volume 5

Chapter I Part 32024 Apr 2011

19 Robert P Heaney Factors Influencing the Measurement of

Bioavailability Taking Calcium as a Model J Nutr 131 2001 1344-

1348

20 Westlake WJ Bioavailability and bioequivalence pharmaceutical

formulations In Peace KE [Ed] Biopharmaceu -tical statistics for

drug development Marcell Dekker New York 1988 329-352

21 Investigation of bioavailability and bioequivalence The rules

governing medicinal products in European Community Vol III

addendum-2 1991 149-169

22 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry-waiver of in vivo bioavailability

and bioequivalence studies for immediate-release solid oral dosage

forms based on a biopharmaceutics classification system August

2000 1-13

23 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry-Bioequivalence

recommendations for specific products Jun 2010 1-4

24 Center for Drug Evaluation and Research US Food and Drug

Administration Inspections of clinical facilities and analytical

laboratories conducting bioequivalence studies submitted in ANDAS

Dec 2000 1-5

25 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use General

considerations for clinical trials-E8 ICH triplicate efficacy guidelines

Version-4 Jul 1997 1-13

26 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Structure and

content of clinical study reports-E3 ICH triplicate efficacy guidelines

Version-4 Nov 1995

27 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Guideline for good

clinical practice-E6 [R1] ICH triplicate efficacy guidelines Version-4

June 1996

28 Michael J McGraw Adam N George Shawn P Shearn and Rigel L

Hall editors Principles of Good Clinical Practice Pharmaceutical

Press 1st edition 2010 245-256

29 Central Drugs Standard Control Organization Directorate General of

Health Services Government of India Guide lines on Good clinical

practice 2005

30 World Health Organization Guidelines for GCP for trials on

pharmaceutical products WHO technical report series Annex-3 850

1995 1-35

31 Department of Health and Human Services US Food and Drug

Administration Protection of human subjects Code of federal

regulations Title 21 Volume-1 Chapter- I part 50

32 Department of Health and Human Services US Food and Drug

Administration Institutional review boards Code of federal

regulations Title 21 volume-1 chapter- I part 56

33 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for institutional review boards clinical

investigators and sponsors Exception from Informed Consent

Requirements for Emergency Research July 2006

34 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Investigator responsibilities

protecting the rights safety and welfare of study subjects Oct 2009

35 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Development

safeties update report-E2F ICH Triplicate efficacy guidelines Version

4 Aug 2010

36 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Clinical safety data

management definitions and standards for expedited reporting-E2A

ICH Triplicate efficacy guidelines Version 4 Oct 1994

37 D M Brahankar sunil B Jaiswal Pharmacokinetics Basic

considerations Biopharmaceutics and Pharmacokinetics Vallabh

Prakashan 2008 212-229

38 Center for Drug Evaluation and Research US Food and Drug

Administration ERIn vitroIn vivo correlations Bioavailability and

Bioequivalence Sep 1997

39 D M Brahankar sunil B Jaiswal Invitro-invivo correlation

Bioavailability and Bioequivalence Biopharmaceutics and

Pharmacokinetics A Treatise Vallabh Prakashan 2008 282-305

40 WHO-Research and training in tropical diseases Handbook of good

laboratory practice Quality practices for regulated non-clinical

research and development 2nd edition 2008 9-40

41 Department of Health and Human Services US Food and Drug

Administration Good laboratory practices for nonclinical laboratory

studies Code of federal regulations Title 21 Volume 1 Chapter- I

Part 58

42 Organisation for Economic Co-operation and Development Good

laboratory practice OECD principles and guidance for compliance

monitoring OECD publishing 2005 13-26

43 Jurg PSeiler Good laboratory practice 2nd edition Springer-Verlag

Berlin Heidelberg European Union 2005 59-103

44 Sandy Weinberg Good laboratory practice regulations 3rd edition

revised and expanded Taylor amp Francis e-Library New York 2005

127-148

forms based on a biopharmaceutics classification system August

2000 1-13

23 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry-Bioequivalence

recommendations for specific products Jun 2010 1-4

24 Center for Drug Evaluation and Research US Food and Drug

Administration Inspections of clinical facilities and analytical

laboratories conducting bioequivalence studies submitted in ANDAS

Dec 2000 1-5

25 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use General

considerations for clinical trials-E8 ICH triplicate efficacy guidelines

Version-4 Jul 1997 1-13

26 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Structure and

content of clinical study reports-E3 ICH triplicate efficacy guidelines

Version-4 Nov 1995

27 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Guideline for good

clinical practice-E6 [R1] ICH triplicate efficacy guidelines Version-4

June 1996

28 Michael J McGraw Adam N George Shawn P Shearn and Rigel L

Hall editors Principles of Good Clinical Practice Pharmaceutical

Press 1st edition 2010 245-256

29 Central Drugs Standard Control Organization Directorate General of

Health Services Government of India Guide lines on Good clinical

practice 2005

30 World Health Organization Guidelines for GCP for trials on

pharmaceutical products WHO technical report series Annex-3 850

1995 1-35

31 Department of Health and Human Services US Food and Drug

Administration Protection of human subjects Code of federal

regulations Title 21 Volume-1 Chapter- I part 50

32 Department of Health and Human Services US Food and Drug

Administration Institutional review boards Code of federal

regulations Title 21 volume-1 chapter- I part 56

33 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for institutional review boards clinical

investigators and sponsors Exception from Informed Consent

Requirements for Emergency Research July 2006

34 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Investigator responsibilities

protecting the rights safety and welfare of study subjects Oct 2009

35 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Development

safeties update report-E2F ICH Triplicate efficacy guidelines Version

4 Aug 2010

36 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Clinical safety data

management definitions and standards for expedited reporting-E2A

ICH Triplicate efficacy guidelines Version 4 Oct 1994

37 D M Brahankar sunil B Jaiswal Pharmacokinetics Basic

considerations Biopharmaceutics and Pharmacokinetics Vallabh

Prakashan 2008 212-229

38 Center for Drug Evaluation and Research US Food and Drug

Administration ERIn vitroIn vivo correlations Bioavailability and

Bioequivalence Sep 1997

39 D M Brahankar sunil B Jaiswal Invitro-invivo correlation

Bioavailability and Bioequivalence Biopharmaceutics and

Pharmacokinetics A Treatise Vallabh Prakashan 2008 282-305

40 WHO-Research and training in tropical diseases Handbook of good

laboratory practice Quality practices for regulated non-clinical

research and development 2nd edition 2008 9-40

41 Department of Health and Human Services US Food and Drug

Administration Good laboratory practices for nonclinical laboratory

studies Code of federal regulations Title 21 Volume 1 Chapter- I

Part 58

42 Organisation for Economic Co-operation and Development Good

laboratory practice OECD principles and guidance for compliance

monitoring OECD publishing 2005 13-26

43 Jurg PSeiler Good laboratory practice 2nd edition Springer-Verlag

Berlin Heidelberg European Union 2005 59-103

44 Sandy Weinberg Good laboratory practice regulations 3rd edition

revised and expanded Taylor amp Francis e-Library New York 2005

127-148

investigators and sponsors Exception from Informed Consent

Requirements for Emergency Research July 2006

34 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Investigator responsibilities

protecting the rights safety and welfare of study subjects Oct 2009

35 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Development

safeties update report-E2F ICH Triplicate efficacy guidelines Version

4 Aug 2010

36 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Clinical safety data

management definitions and standards for expedited reporting-E2A

ICH Triplicate efficacy guidelines Version 4 Oct 1994

37 D M Brahankar sunil B Jaiswal Pharmacokinetics Basic

considerations Biopharmaceutics and Pharmacokinetics Vallabh

Prakashan 2008 212-229

38 Center for Drug Evaluation and Research US Food and Drug

Administration ERIn vitroIn vivo correlations Bioavailability and

Bioequivalence Sep 1997

39 D M Brahankar sunil B Jaiswal Invitro-invivo correlation

Bioavailability and Bioequivalence Biopharmaceutics and

Pharmacokinetics A Treatise Vallabh Prakashan 2008 282-305

40 WHO-Research and training in tropical diseases Handbook of good

laboratory practice Quality practices for regulated non-clinical

research and development 2nd edition 2008 9-40

41 Department of Health and Human Services US Food and Drug

Administration Good laboratory practices for nonclinical laboratory

studies Code of federal regulations Title 21 Volume 1 Chapter- I

Part 58

42 Organisation for Economic Co-operation and Development Good

laboratory practice OECD principles and guidance for compliance

monitoring OECD publishing 2005 13-26

43 Jurg PSeiler Good laboratory practice 2nd edition Springer-Verlag

Berlin Heidelberg European Union 2005 59-103

44 Sandy Weinberg Good laboratory practice regulations 3rd edition

revised and expanded Taylor amp Francis e-Library New York 2005

127-148

45 Willa Y Garner Maureen S Barge James P Ussary Good laboratory

practice standards Applications for field and laboratory studies

American Chemical Society 1992 124-132

46 Milton A Anderson GLP essentials a concise guide to good

laboratory practice 2nd edition Interpharm Press 2002 15-30

47 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Exposure-response

relationships-study design data analysis and regulatory applications

Apr 2003

48 International conference on harmonisation of technical requirements

for registration of pharmaceuticals for human use Statistical

principles for clinical trials-E9 ICH harmonised tripartite efficacy

guideline Feb 1998

49 Schuirmann DJ A comparison of the two one-sided test procedure

and the power approach for assessing the equivalence of average

bioavailability J Pharmacokinet Biopharm 15 1987 657-680

50 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for Industry Guidance for industry

Statistical approaches establishing bioequivalence Jan 2001 1-45

51 Murray R Spiegel Curve fitting Regression Planes and Correlation

Coefficients Probability and Statistics 2004 278-327

52 Steinijans VW and Hauschke D Update on the statistical analysis of

bioequivalence studies International journal of clinical pharmacology

therapy and toxicology 30[1] 1992 45-50

53 Lloyd R Snyder Joseph J Kirkland Joseph L Glash Practical HPLC

method development Wiley India Pvt Ltd 2004 15-45

54 Center for Drug Evaluation and Research US Food and Drug

Administration Safety testing of drug metabolites Feb 2008

55 HPFBTPD [Canada guidelines] Metabolites in comparative

Bioavailability studies Draft May 2004

56 Center for Drug Evaluation and Research US Food and Drug

Administration Drug Metabolism Interactions Nov 1999

57 Center for Drug Evaluation and Research US Food and Drug

Administration Drug interaction studies-study design data analysis

and implications for dosing and labeling Draft Sep 2006

58 D M Brahankar sunil B Jaiswal Phase-I reactions

Biotransformation of drugs Biopharmaceutics and Pharmacokinetics

A Treatise Vallabh Prakashan New Delhi 2008 117-137

59 D M Brahankar sunil B Jaiswal Phase-II reactions

Biotransformation of drugs Biopharmaceutics and Pharmacokinetics

A Treatise Vallabh Prakashan 2008 138-146

60 Gurdeep R Chatwal Sham K Anand Introduction to Instrumental

Chemical Analysis Instrumental methods of chemical analysis

Himalaya Publishing House 2009 11-124

61 Douglas A Skoog Donald M West F James Holler Stanley R

Crouch Sampling Standardization and Calibration Tools of

Analytical Chemistry Fundamentals of Analytical Chemistry 8th

edition Thomson BrooksCole Thomson Asia Pvt Ltd Singapore

2004 175-227

62 Naidong Wong and Timothy DJHalls Systematic troubleshooting for

LCMSMS Part 1- Sample preparation and chromatography

Process development Biopharm November 2001 28-38

63 D M Brahankar sunil B Jaiswal Excreation of drugs

Biopharmaceutics and Pharmacokinetics A Treatise Vallabh

Prakashan New Delhi 2008 178-201

64 N Weng Novel liquid chromatographic-tandem mass spectrometric

methods using silica columns and aqueous-organic mobile phases for

quantitative analysis of polar ionic analytes in biological fluids j

Chromatogr B 754 2001 387-399

65 Richard FVenn Phsico-Chemical properties of drugs and metabolities

and their extraction from biological material Principles and Practice

of bioanalysis 2007 110-140

66 N Weng Development and validation of a sensitive method for the

hydromorphone in human plasma by normal phase liquid

chromatography-tandem mass spectrometry j Pharm Biomed Anal

23 2000 697-704

67 P Lu Process purification of polypeptides and proteins by reversed-

phase column chromatography Misconceptions and Reality

biopharm 14[9] 2001 28-35

68 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Bioanalytical Method

Validation May 2001

69 Brazilian Sanitary Surveillance Agency Bioanalytical method

validation ANVISA guidelines May 2003

70 Brazilian Sanitary Surveillance Agency Explanation of the

implementation of re no 8992003 - validation of bioanalytical

methods ANVISA guidelines Jun 2008

71 Brazilian Sanitary Surveillance Agency Manual for good

bioavailability and bioequivalence practices volume-1 [clinics

analytics and statistics ANVISA guidelines 2002

72 European Directorate for the Quality of Medicines and Health Care

Guideline on validation of analytical procedures PAPHOMCL [05]

47 De OMCL network of the council of Europe quality assurance

document Jun 2005

73 International conference on harmonization of technical requirements

for registration of pharmaceuticals for human use Validation of

analytical procedures Text and Methodology-Q2 [R1] ICH

harmonised tripartite quality guidelines Version-4 Nov 2005

74 Center for Drug Evaluation and Research US Food and Drug

Administration Reviewer guidance- Validation of chromatogram -phic

methods Nov 1994

75 Brazilian Sanitary Surveillance Agency Manual for good

bioavailability and bioequivalence practices Volume-2 [Micropipette

Water for Analysis Instrumentation] ANVISA guidelines 2002

76 Center for Drug Evaluation and Research US Food and Drug

Administration Guidance for industry Analytical procedures and

methods validation- chemistry manufacturing and controls

documentation Draft guidance Aug 2000

77 Frank Chow Arlene Ocampo Paul Vogel Steven Lum and Nhan Tran

Current challenges for FDA-regulated bioanalytical laboratories

performing human BABE studies Part III Selected discussion topics

in bioanalytical LCMSMS method validation Journal of Quality

Assurance 12 2009 22-30

78 C T Viswanathan Surendra Bansal Brian Booth Anthony J

Destefano Mark J Rose Jeffrey Sailstad Vinod P Shah Jerome P

Skelly Patrick G Swann and Russell Weiner Quantitative

bioanalytical methods validation and implementation Best practices

for chromatographic and ligand binding assays The AAPS journal 9

[1] Article-4 2007

79 Bansal S and Destefano A Key elements of bioanalytical method

validation for small molecules American association of

pharmaceutical sciences journal 9[1] 2007 109-114

80 Roger Causon Validation of chromatographic methods in biomedical

analysis viewpoint and discussion Journal of Chromatography B

Biomedical Sciences and Applications 689[1] 7 Feb 1997 175-180

81 King R Bonfiglio R Fernandez-Metzler C Miller-Stein C Olah T

Mechanistic investigation of ionization suppression in electrospray

ionization J Am Soc Mass spectrom 11 2000 942-950

82 DL Buhrman PI Price and PJ Rudewicz Quantitation of sr27417

in human plasma using electrospray liquid chromatography-tandem

mass spectrometry a study of ion suppression J Am Soc Mass

spectrom 7 1996 1099-1105

83 J R Lang S Bolton A comprehensive method validation strategy for

bioanalytical applications in the pharmaceutical industry-2

Statistical analyses Journal of Pharmaceutical and Biomedical

Analysis 9[6] 1991 435-442

84 Dadgar D Burnett PE Issues in evaluation of bioanalytical method

selectivity and drug stability JPharmBiomedAnal 14 1995 23-31

85 Gurdeep R Chatwal Sham K Anand Errors Accuracy and Precision

Instrumental Methods of Chemical Analysis Himalaya Publishing

House New Delhi 2009 21-26

86 Swartz ME and Krull IS Validation of chromatographic methods

Pharmaceutical Technology 22[33] 1998 104-119

87 Gary DChristian High performance liquid chromatography

Analytical Chemistry Wiley India Pvt Ltd 2007 537-548

88 Gurdeep R Chatwal Sham K Anand High performance liquid

chromatography Instrumental Methods of Chemical Analysis

Himalaya Publishing House New Delhi 2009 2624-2639

89 Douglas A Skoog Donald M West F James Holler Stanley R

Crouch High performance liquid chromatography Fundamentals of

Analytical Chemistry 8th edition Thomson BrooksCole Thomson

Asia Pte Ltd Singapore 2004 973-995

90 Ghulam A Shabir HPLC method development and validation for

pharmaceutical analysis Pharmaceutical Technology Mar 2004

91 MS Lee and ED Kerns LCMS applications in drug development

Mass spectrom Rev 18 1999 187-279

92 Gurdeep R Chatwal Sham K Anand Mass Spectrometry

Instrumental Methods of Chemical Analysis Himalaya Publishing

House 2009 2272-2302

80 Roger Causon Validation of chromatographic methods in biomedical

analysis viewpoint and discussion Journal of Chromatography B

Biomedical Sciences and Applications 689[1] 7 Feb 1997 175-180

81 King R Bonfiglio R Fernandez-Metzler C Miller-Stein C Olah T

Mechanistic investigation of ionization suppression in electrospray

ionization J Am Soc Mass spectrom 11 2000 942-950

82 DL Buhrman PI Price and PJ Rudewicz Quantitation of sr27417

in human plasma using electrospray liquid chromatography-tandem

mass spectrometry a study of ion suppression J Am Soc Mass

spectrom 7 1996 1099-1105

83 J R Lang S Bolton A comprehensive method validation strategy for

bioanalytical applications in the pharmaceutical industry-2

Statistical analyses Journal of Pharmaceutical and Biomedical

Analysis 9[6] 1991 435-442

84 Dadgar D Burnett PE Issues in evaluation of bioanalytical method

selectivity and drug stability JPharmBiomedAnal 14 1995 23-31

85 Gurdeep R Chatwal Sham K Anand Errors Accuracy and Precision

Instrumental Methods of Chemical Analysis Himalaya Publishing

House New Delhi 2009 21-26

86 Swartz ME and Krull IS Validation of chromatographic methods

Pharmaceutical Technology 22[33] 1998 104-119

87 Gary DChristian High performance liquid chromatography

Analytical Chemistry Wiley India Pvt Ltd 2007 537-548

88 Gurdeep R Chatwal Sham K Anand High performance liquid

chromatography Instrumental Methods of Chemical Analysis

Himalaya Publishing House New Delhi 2009 2624-2639

89 Douglas A Skoog Donald M West F James Holler Stanley R

Crouch High performance liquid chromatography Fundamentals of

Analytical Chemistry 8th edition Thomson BrooksCole Thomson

Asia Pte Ltd Singapore 2004 973-995

90 Ghulam A Shabir HPLC method development and validation for

pharmaceutical analysis Pharmaceutical Technology Mar 2004

91 MS Lee and ED Kerns LCMS applications in drug development

Mass spectrom Rev 18 1999 187-279

92 Gurdeep R Chatwal Sham K Anand Mass Spectrometry

Instrumental Methods of Chemical Analysis Himalaya Publishing

House 2009 2272-2302

93 YRSharma Mass spectroscopy Principles and chemical

applications Elementary Organic Spectroscopy SChand amp Company

Ltd New Delhi 2005 234-281

94 N Weng Simultaneous development of six LC-MS-MS methods for

the determination of multiple analytes in human plasma J Pharm

Biomed Anal 2001

95 Naidong Wong and Timothy DJHalls Systematic troubleshooting for

LCMSMS Part 2-Large-scale LCMSMS and automation Process

Development Biopharm Jan 2002 22-27

96 Naidong Wong and Timothy DJHalls Systematic troubleshooting for

LCMSMS Process Development Biopharm Mar 2002 102-120

97 Garg Deependra Singh Swarnlata Saraf and S Saraf Aceclofenac a

potent non-steroidal anti-inflammatory pharmainfonet 2005-2006

98 Gureje O Von Korff M Simon Ge Gater R Persistent pain and well-

being a World Health Organization study in primary care journal of

American medical association 280[2] Jul 1998 147-51

99 Dooley M Spencer CM Dunn CJ Aceclofenac a reappraisal of its use

in the management of pain and rheumatic disease drugs 61[9]

2001 1351-78

100 DAhartman SJOchalski and RPCarlson The effects of anti-

inflammatory and antiallergic drugs on cytokine release after

stimulation of human whole blood by lipopolysaccharide and

zymosana Inflammation research 44 [7] 269-274

101 Lemmel EM Leeb B DE Bast J Aslanidis S Patient and physician

satisfaction with aceclofenac results of the European observational

cohort study [experience with aceclofenac for inflammatory pain in

daily practice] Aceclofenac is the treatment of choice for patients and

physicians in the management of inflammatory pain 18[3] 2002

146-53

102 Yamazaki R Kawai S Matsuzaki T Kaneda N Hashimoto S

Yokokura T et al Aceclofenac blocks prostaglandin E2 production

following its intracellular conversion into cyclo-oxygenase

inhibitors European journal of pharmacology 329 1997 181-7

103 Blot L Marcelis A Devogelaer JP Manicourt DH Effects of diclofenac

aceclofenac and meloxicam on the metabolism of proteoglycans and

hyaluronan in osteoarthritic human cartilage British journal of

pharmacology 131[7] Dec 2000 1413-21

104 Santanu Ghosh and BB Barik Preparation and evaluation of

aceclofenac sustained release formulation and comparison of

formulated and marketed product International journal of medicine

and medical sciences 1 [9] Sept 2009 375-382

105 Pawar VT Pishawika SA More HN Spectrophotometric estimation

of aceclofenac and paracetamol from tablet dosage form Current

Pharma Research 1[1] Oct-Dec 2010

106 Jyotesh Jain Riddhish Patadia Divyesh Vanparia Renu Chauhan

Shailesh Shah Dual wavelength spectrophotometric method for

simultaneous estimation of drotaverine hydrochloride and aceclofenac

in their combined tablet dosage form International journal of

pharmacy and pharmaceutical sciences 2[4] 2010

107 Santosh Gandhi Padmanabh Deshpande Vivek Rajmane Tanmay

Dodal Jitesh Parab Method development and validation for

simultaneous estimation of drotaverine hydrochloride and aceclofenac

in tablet dosage form by RP-HPLC International journal of

pharmaceutical sciences review and research 4[3] Sep-Oct 2010

108 Gopinath R Rajan S Meyyanathan SN Krishnaveni N and Suresh A

RP-HPLC method for simultaneous estimation of paracetamol and

aceclofenac in tablets Indian journal of pharmaceutical sciences

69[1] 2007 137-140

109 Prashant musmade G Subramanian and KK Srinivasan High-

performance liquid chromatography and pharmacokinetics of

aceclofenac in rats Anal Chim Acta 585 [1] 28 Feb 2007 103-109

110 N H Zawilla M Abdul Azim Mohammad NMEL Kousya S M EL-

moghazy aly Determination of aceclofenac in bulk and

pharmaceutical formulations Journal of pharmaceutical and

biomedical analysis 27 [1-2] 1 Jan 2002 243-251

111 Santosh Bhalerao Santosh Tambe Vikas Pareek Rupali Shinde Lalit

Kumar Gupta A solid-liquid extraction and high performance thin

layer chromatographic determination of diacerein and aceclofenac in

pharmaceutical tablet dosage form Asian journal of pharmaceutical

and clinical research 3[1] Jan-Mar 2010

112 JBagyalakshmi Sajna John and TKRavi Development and

validation of simultaneous estimation of paracetamol aceclofenac and

rabeprazole in combined tablet dosage formulation by HPTLC method

Pelagia research library Der Pharmacia Sinica 2 [2] 2011 43-50

113 Hye Suk Lee Chang Kyun Jeonga Sung Jin Choia Sang Beom

Kima Mi Hyun Leea Geon Koa and Dong Hwan Sohna

Simultaneous determination of aceclofenac and diclofenac in human

plasma by narrow bore HPLC using column-switching Journal of

pharmaceutical and biomedical analysis 23[5] Oct 2000 775-781

114 Godse VP Deodhar MN Bhosale AV Sonawane RA Sakpal PS

Borkar DD and Bafana YS Reverse phase HPLC method for

determination of aceclofenac and paracetamol in tablet dosage form

Asian j Research Chem 2[1] Jan-Mar 2009

115 Vishnu Choudhari Kunal Ingale Madhusmita Sahoo Pratima Syal

Snehal Ingale Santosh Shinde Abhijit Sutar Bhanudas Kuchekar

Development and validation of a RP-HPLC-PDA method for

simultaneous estimation of drotaverine and aceclofenac in a

combined dosage form int J Res Pharm Sci 1[3] 2010 253-258

116 Laxminarayan R Parry IWH Smith DL Klein E should new

antimalarial drugs be subsidized J health econ 29 2010 445-456

117 World Health Organisation [2006] WHO guidelines for the treatment

of malaria 2nd edition 1 may 2010

118 World health Organisation [2009] World Malaria Report 1 may 2010

119 Jared N Cumming Poonsakdi Ploypraditha and Gary H Posnera

Antimalarial activity of artemisinin [qinghaosu] and related trioxanes

mechanism[s] of action Advances in pharmacology 37 1996 253-

297

120 Washington DC Institute of medicine of the national

academies saving lives buying time Economics of malaria drugs in

an age of resistance National Academies Press 2004

121 Mccombie SC Treatment seeking for malaria a review of recent

research Soc Sci Med 43 1996 933-945

122 Williams HA Jones CO A critical review of behavioral issues related

to malaria control in sub-Saharan Africa Soc Sci Med 59 2004 501-

523

123 Roll back malaria-2007[RBM] Affordable medicines facility-malaria

[AMFm] 5 may 2010

124 Talisuna A Grewal P Rwakimari JB Mukasa S Jagoe G et al Cost

is killing patients Subsidising effective antimalarials Lancet 374

2009 1224-1226

125 Goodman C Brieger W Unwin A Mills A Meek S et al Medicine

sellers and treatment in sub-Saharan Africa Am J Trop Med Hyg

77[6] 2007 203-218

126 Smith LA Jones C Meek S Webster J Provider practice and user

behavior interventions to improve prompt and effective treatment of

malaria do we know what works Am j Trop Med Hyg 80[3] 2009

326-335

127 Oxfam Challenging the myths about private healthcare in poor

countries Blind optimism Oxfam briefing paper 3 may 2010

128 Noor AM Gething PM Alegana VM Patil A Hay SI et al The risks of

malaria infection in Kenya BMC Infectious Diseases 9 2009 180

129 Kangwana BB Njogu J Wasunna B Kedenge SV Memusi DN et al

Malaria drug shortages in Kenya a major failure to provide access to

effective treatment Am J Trop Med Hyg 80 2009 737-738

130 Van Vugt M Looareesuwan S Wilairatana P MC Gready R Villegas

L Gathmann I Mull R Brockman A White Nj Nosten F Artemether-

lumefantrine for the treatment of multidrug-resistant falciparum

malaria Transactions of the Royal Society of Tropical Medicine and

Hygeine 94[5] Sep-Oct 2000 545-8

131 Sabot OJ Mwita A Cohen JM Ipuge Y Gordon M et al Piloting the

global subsidy the impact of subsidized artemisinin-based

combination therapies distributed through private drug shops in rural

Tanzania Plos one 4[9] 2009 6857

132 Sabot O Yeung S Pagnoni F Gordon M Petty Net al Distribution of

artemisinin-based combination therapies through private-sector

channels RFF Discussion Paper 2009 08-43

133 Dalessandro U Talisuna M Boelaert M Should artemisinin-based

combination treatment be used in the home-based manaalaria Trop

Med Int Health 10 2005 1-2

134 Richard K Haynes Simone C Vonwiller Extraction of artemisinin

and artemisinic acid preparation of artemether and new analogues

Transactions of the Royal Society of Tropical Medicine and Hygiene

88[1] June 1994 23-26

135 Dharmarajan Sriram Vajja Sambasiva Rao Kondapalli Venkata

Gowri Chandrasekhar Perumal Yogeeswari Progress in the research

of artemisinin and its analogues as antimalarials Natural Product

Research formerly natural product letters 18[6] 2004 503-527

136 N Sandrenan A Sioufi J Godbillon C Netter M Donker C Van

Valkenburg Determination of artemether and its metabolite

dihydroartemisinin in plasma by high-performance liquid

chromatography and electrochemical detection in the reductive mode

Journal of chromatography-B 691[1] mar1997 145-153

137 D K Muhia E K Mberu and W M Watkins Differential extraction

of artemether and its metabolite dihydroartemisinin from plasma and

determination by high-performance liquid chromatography Journal of

Chromatography B Biomedical Sciences and Applications 660[1] 3

Oct 1994 196-199

138 Toufigh Gordi Elisabet Nielsena Zuoxiang Yub Douglas Wester

Lund and Michael Ashton Direct analysis of artemisinin in plasma

and saliva using coupled-column high-performance liquid

chromatography with a restricted-access material pre-column

Journal of Chromatography B Biomedical Sciences and Applications

742[1] 26 may 2000 155-162

139 Bonnie A Avery Krishna K Venkatesha and Mitchell a Avery Rapid

determination of artemisinin and related analogues using high-

performance liquid chromatography and an evaporative light

scattering detector Journal of chromatography B Biomedical

Sciences and Applications 730[1] 25 June 1999 71-80

140 Paktiya Teja-Isavadharm James O Peggins Thomas G Brewer

Nicholas J Whit H Kyle Webster and Dennis E Kyle Plasmodium

falciparum-based bioassay for measurement of artemisinin derivatives

in plasma or serum Antimicrobial agents and chemotherapy 48[3]

Mar 2004 954-960

141 Dwight L Mounta G Daniel Todda and V Navaratnamb Packed-

column supercritical fluid chromatography of artemisinin [qinghaosu]

with electron-capture detection Journal of Chromatography B

Biomedical Sciences and Applications 666[1] 7 April 1995 183-187

142 SS Mohamed SA Khalid SA Ward TSM Wan HPO Tang M

Zheng Simultaneous determination of artemether and its major

metabolite dihydroartemisinin in plasma by gas chromatography-

mass spectrometry-selected ion monitoring Journal of

Chromatography B 731 1999 251-260

143 PSahai RAVishwakarma SBharel AGulati MZAbdin PS

Srivastava and SKJain HPLC-Electrospray ionization mass

spectrometric analysis of antimalarial drug artemisinin Anal Chem

70[14] 1998 3084-3087

144 RK Haynes G Edwards C Souppart N Gauducheau N Sandrenan

and F Richard Development and validation of a high-performance

liquid chromatography-mass spectrometry assay for the

determination of artemether and its metabolite dihydro-artemisinin in

human plasma Journal of chromatography B 774 2002 195-203

145 Magalhaes IR Jabor VA Faria AM Collins CH Jardim IC Bonato PS

Determination of beta-artemether and its main metabolite

dihydroartemisinin in plasma employing liquid-phase micro extraction

prior to liquid chromatographic-tandem mass spectrometric analysis

Talanta 81[3] 15 may 2010 941-7

146 MRajanikanth KPMadhusudanan and RCGupta Liquid

chromatographic-mass spectrometric method for the determination of

α- β-arteether in rat serum Journal of chromatography B 783[2]

15 Jan 2003 391-399

147 The Merck Index 9th edition Rahway New Jersey Merck amp co inc

1976 50

148 Osol A and JE Hoover et al Remingtonrsquos pharmaceutical sciences

15th edition Easton Pennsylvania Mack publishing co 1975 850

149 Wittmann T Paradowski L Ducrotte P Bueno L Andro Aelestrain

MC Clinical trial the efficacy of alverine citratesimeticone

combination on abdominal paindiscomfort in irritable bowel

syndrome-a randomized double-blind placebo-controlled study

Alimentary Pharmacology amp Therapeutics 31[6] 2010 615-24

150 T Wittmann L Paradowski P Ducrott L Bueno MC Andro

delestrain Clinical trial the efficacy of alverine citratesimeticone

combination on abdominal paindiscomfort in irritable bowel

syndrome - a randomized double-blind placebo-controlled study

Alimentary pharmacology amp therapeutics 31[6] 2010 615-624

151 Coelho AM Jacob L Fioramonti J and Bueno L Rectal

antinociceptive properties of alverine citrate are linked to antagonism

at the 5-HT1A receptor subtype J Pharm Pharmacology 53 2001

1419-1426

152 Hayase M Hashitani H Suzuki H Kohri K and Brading A Evolving

mechanisms of action of alverine citrate on phasic smooth muscles

Br j pharmacol 152[8] Dec 2007 1228-1238

153 Bouvier M Grimaud JC Abysique A and Chiarelli P Effects of

alverine on the spontaneous electrical activity and nervous control of

the proximal colon of the rabbit Gastroenterol clin Biol 16 1992

334-338

154 Abysique A Lucchini S Orsoni P Mei N and Bouvier M Effects of

alverine citrate on cat intestinal mechanoreceptor responses to

chemical and mechanical stimuli Aliment Pharmacol Ther 13

1999 561-566

155 Arhan M Koklu S Koksal AS Yolcu OF Koruk S Koruk I and

Kayacetin E Alverine citrate induced acute hepatitis World j

gastroenterol 10[15] 2004 2303-2304

156 Noel A Gomesa Avdhoot Lauda Ashutosh Pudage Santosh S Joshi

Vikas V Vaidyaa and Jayram A Tandel Validated LC-MSMS method

for determination of alverine and one of its hydroxy metabolites in

human plasma along with its application to a bioequivalence study

Journal of Chromatography B 877 2009 197-206

157 Rahul C Gavhane Ketan K Nerurkar Ashok M Kalamkar Mitesh

R Patil Satish G Pingale and Prafullakumar Kulkarni Liquid

chromatographytandem mass spectrometry for the simultaneous

determination of alverine and its metabolite monohydroxy alverine in

human plasma application to a pharmacokinetic study E-journal of

chemistry 8[1] 2011 201-211

158 Ghosh C Jha V Ahir R Shah S Shinde CP Chakraborty BS A rapid

and most sensitive liquid chromatographytandem mass spectrometry

method for simultaneous determination of alverine and its major

metabolite para hydroxy alverine in human plasma application to a

pharmacokinetic and bioequivalence study Drug Testing Analysis

2[6] Jun 2010 284-91

159 Herbert JM Frehel D Bernat A Badorc A Savi P Delebassee D

Kieffer G Defreyn G Maffrand JP Clopidogrel hydrogenosulfate Drug

Future 18 1993 107-112

160 Karsten Schror Clinical pharmacology of the adenosine diphosphate

[ADP] receptor antagonist clopidogrel Vascular Medicine 3 1998

247ndash251

161 Sugidachi A Asai F Ogawa T Inoue T and Koike H The in vivo

pharmacological profile of CS-747 a novel antiplatelet agent with

platelet ADP receptor antagonist properties B J Pharmacol 129

2000 1439-1446

162 Savi P Labouret C Delesque N Guette F Lupker J and Herbert JM

P2Y12- a new platelet ADP receptor target of Clopidogrel Biophys

Biochem Res Commun 283 2001 379-383

163 Savi P Combalbert J Gaich C Rouchon MC Maffrand JP Berger Y

and Herbert JM The anti aggregating activity of Clopidogrel is due to

a metabolic activation by hepatic cytochrome P450-1A Thromb

Haemostasis 72 1994 313-317

164 Savi P Pereillo JM Uzabiaga F Combalbert J Picard C Maffrand JP

Pascal M and Herbert JM Identification and biological activity of the

metabolite of Clopidogrel Thromb Haemostasis 84 2000 891-896

165 Herbert JM Savi P and Maffrand JP Biochemical and

pharmacological properties of Clopidogrel a new ADP receptor

antagonist Eur Heart J 1 [Suppl A] 1999 31-40

166 Robinson A Hillis J Neal C Leary AC The validation of a

bioanalytical method for the determination of clopidogrel in human

plasma Journal of Chromatography B Analyt Technol Biomed Life

Sci [2] 848 2007 344-54

167 Shin BS Yoo SD Determination of clopidogrel in human plasma by

liquid chromatographytandem mass spectrometry application to a

clinical pharmacokinetic study Biomed Chromatogr 21[9] 2007

883-9

168 Ramakrishna V S Nirogi Vishwottam N Kandikere Manoj Shukla

Koteshwara Mudigonda Santosh Maurya and Ravikumar Boosi

Quantification of clopidogrel in human plasma by sensitive liquid

chromatographytandem mass spectrometry Rapid Communications

in Mass Spectrometry 20[11] 1695-1700

169 Effat Souri Hassan Jalalizadeh Abbas Kebriaee-Zadeh Maral

Shekarchi Afshin Dalvandi Validated HPLC method for

determination of carboxylic acid metabolite of clopidogrel in human

plasma and its application to a pharmacokinetic study Biomedical

Chromatography 20[12] 1309-1314

170 Singh Sonu S Sharma Kuldeep Barot Deepak Ram Mohan P and

Lohray vidya B Estimation of carboxylic acid metabolite of clopidogrel

in wistar rat plasma by HPLC and its application to a

pharmacokinetic study Journal of chromatography-B 821[2] 2005

173-180

171 Gholamreza Bahrami High-performance liquid chromatographic

determination of inactive carboxylic acid metabolite of clopidogrel in

human serum Application to a bioequivalence study J Chrom 864

[1-2] 15 Mar 2008 168-172

172 Hanna Ksycinska Piotr Rudzk and Mirosława Bukowska-Kiliszek

Determination of clopidogrel metabolite [sr26334] in human plasma

by LC-MS journal of pharmaceutical and biomedical analysis 41[2]

3 may 2006 533-539

173 Takahashi M Pang H Kawabata K Farid NA and Kurihara A

Quantitative determination of clopidogrel metabolite in human plasma

by LC-MSMS J Pharm Biomed Anal 48[4] 2008 1219-24

174 Xavier Delavenne Thierry Basset Paul Zufferey Nora Malouk Silvy

Laporte Patrick Mismetti Ultra-performance LC MSMS method for

quantification of clopidogrel active metabolite Journal of Separation

Science33[13] July 2010 1968ndash1972

175 JL Herman Generic method for on-line extraction of drug

substances in the presence of biological matrices using turbulent flow

chromatography Rapid communications in mass spectrometry 16[5]

March 2002 421-426

176 UAbshagen A New Molecule with vasodilating and [beta]-

adrenoceptor blocking properties Journal of Cardiovascular

Pharmacology 10 1987 S23

177 KStrein GSponer BMuller-Beckmann W Bartsch Pharmacological

Profile of Carvedilol a Compound with [beta]-Blocking and

Vasodilating Properties Journal of Cardiovascular Pharmacology 10

1987 S33

178 W Bartsch G Sponer K Strein B Muller-Beckmann L Kling E

Bohm U Martin HO Borbe Pharmacological characteristics of the

stereoisomers of carvedilol Eur J Clin Pharmacol 38 1990 S104

179 G Sponer K Strein B Muller-Beckmann W Bartsch Studies on

the Mode of Vasodilating Action of Carvedilol Journal of

Cardiovascular Pharmacology 10 1987 S42

180 RR Ruffolo jr M Gellai JP Hieble RN Willette AJ Nichols The

pharmacology of carvedilol Eur J Clin Pharmacol 38 1990 S82

181 MA Pfeffer LW Stevenson Beta-adrenergic blockers and survival in

heart failure The New Engalnd Journal of Medicine 334 1996 1396

182 M Packer MR Bristow JN Cohn WS Colucci MB Fowler EM

Gilbert NH Shusterman The effect of carvedilol on morbidity and

mortality in patients with chronic heart failure The New England

Journal of Medicine 334 1996 1349

183 SA Fahlbusch D Tsikas C Mehls FM Gutzki RH Boger JC

Frolich DO Stichtenoth Effects of carvedilol on oxidative stress in

human endothelial cells and healthy volunteers Eur J Clin

Pharmacol 60 2004 83

184 C De Mey K Breithaupt J Schloos G Neugebauer D Palm GG

Belz Dose-effect and pharmacokinetic-pharmacodynamic

relationships of the beta 1-adrenergic receptor blocking properties of

various doses of carvedilol in healthy humans Clin Pharmacol Ther

55 1994 329

185 F Varin LX Cubeddu JR Powell Liquid chromatographic assay

and disposition of carvedilol in healthy volunteers J Pharm Sci 75

1986 1195

186 P Ptacek J Macek J Klima Liquid chromatographic determination

of carvedilol in human plasma Journal of Chromatography B 789[2]

15 Jun 2003 405-410

187 Eric Yang Sherry Wang John Kratz and Matthew J Cyronak

Stereoselective analysis of carvedilol in human plasma using

HPLCMSMS after chiral derivatization Journal of Pharmaceutical

and Biomedical Analysis 36[3] 15 Nov 2004 609-615

188 N Hokama N Hobara H Kameya S Ohshiro M Sakanashi Rapid

and simple micro-determination of carvedilol in rat plasma by high-

performance liquid chromatography Journal of Chromatography B

Biomedical Sciences and Applications 732 [1] 10 Sep 1999 233-238

189 EJ Eisenberg WR Patterson GC Kahn High-performance liquid

chromatographic method for the simultaneous determination of the

enantiomers of carvedilol and its O-desmethyl metabolite in human

plasma after chiral derivatization Journal of Chromatography B

Biomedical Sciences and Applications 493 1989 105-115

190 LClohs KMMcErlane Comparison between capillary electrophoresis

and high-performance liquid chromatography for the stereoselective

analysis of carvedilol in serum Journal of Pharmaceutical and

Biomedical Analysis 31[3] 10 Mar 2003 407-412

191 JOravcova DSojkova WLindner Comparison of the Hummel-

Dreyer method in high-performance liquid chromatography and

capillary electrophoresis conditions for study of the interaction of

[RS]- [R]- and [S]-carvedilol with isolated plasma proteins

Applications 12 Jul 1996 349-357

192 H Spahn W Henke P Langguth J Schloos E Mutschler

Measurement of carvedilol enantiomers in human plasma and urine

using S-naproxen chloride for chiral derivatization Archiv der

Pharmazie 323[8] 1990 465-469

193 G Neugebauer W Akpan B Kaufmann K Reiff Stereoselective

disposition of carvedilol in man after intravenous and oral

administration of the racemic compound Eur J Clin Pharmacol 38

1990 108-111

194 D Tenero S Boike D Boyle B Ilson HF Fesniak S Brozena D

Jorkasky Steady-state pharmacokinetics of carvedilol and its

enantiomers in patients with congestive heart failure Clin Pharmacol

40[8] 1 Aug 2000 844-853

195 Ney Carter do Carmo Borgesa et al Quantification of carvedilol in

human plasma by high-performance liquid chromatography coupled

to electrospray tandem mass spectrometry Application to

bioequivalence study Journal of Chromatography B 822[1-2] 5 Aug

2005 253-262

196 M Gergov JN Robson E Duchoslav I Ojanpera Automated liquid

chromatographictandem mass spectrometric method for screening β-

blocking drugs in urine Journal of Mass Spectrometry 35[7] Jul

2000 912-918

197 K Reiff Quantification of carvedilol in human plasma by high-

performance liquid chromatography coupled to electrospray tandem

mass spectrometry application to bioequivalence study J

Chromatogr 413 2005 355

198 SN Anavekar et al Pharmacokinetics and antihypertensive effects of

low dose clonidine during chronic therapy J Clin Pharmacol 29[4] 1

Apr 1989 321-326

199 Jorg Huwyler Gert Fricker Michael Torok Markus Schneider and

Jurgen Drewe Transport of Clonidine across Cultured Brain

Microvessel Endothelial Cells Pharmacology 282[1] 1997 81-85

200 Methylphenidate and Clonidine Help Children with ADHD and Tics

National Institute of Neurological Disorders and Stroke 2002

201 Schapiro NA Dude you dont have Tourettersquos Tourettersquos syndrome

beyond the tics Pediatr Nurs 28[3] May-Jun 2002 243-6 249-53

202 Guang-Ming KE Li Wang Hui-Yong Xue Wan-Liang LU Xuan

Zhang Qiang Zhang and Hong-You Guo In Vitro and in Vivo

Characterization of a Newly Developed Clonidine Transdermal Patch

for Treatment of Attention Deficit Hyperactivity Disorder in Children

Biol Pharm Bull 28[2] 2005 305-310

203 Determination of chlorthalidone and clonidine hydrochloride in

tablets by HPLC J Chromatogr Sci 21[1] Jan 1983 43-5

204 CChu WFBayne FTTao LGSchmitt JEShaw Determina -tion

of submicrogram quantities of Clonidine in biological fluids Journal

of Pharmaceutical Sciences 68[1] 72-74

205 Edlumd PO Paalzow LK Quantitative gas-liquid chromatogram -phic

determination of clonidine in plasma Acta Pharmacol Toxicol

[Copenh] 40[1] Jan 1977 145-52

206 C Muller M Ramic S Harlfinger C Huumlnseler M Theisohn and B

Roth Sensitive and convenient method for the quantification of

Clonidine in serum of pediatric patients using liquid

chromatographytandem mass spectrometry Journal of

Chromatography A 1139[2] 19 Jan 2007 221-227

207 Mary Pelzer Thomas Addison Wenbao Li Xiangyu Jiang Naidong

Weng Development and validation of a liquid chromatography-

tandem mass spectrometry method using silica column and aqueous-

organic mobile phase for the analysis of clonidine as low as 10 pgml

in human serum Journal of Liquid Chromatography amp Related

Technologies 25[7] May 2002 1019 -1032

208 Janssen Pharmaceutica Products Sporanox [Lumefantrine] injection

US Food and Drug Administration 2002

209 MVan Vugt ABrockman BGemperli CLuxemburger IGathmann

CRoyce TSlight SLooareesuwan NJWhite FNosten Randomized

Comparison of Artemether-Benflumetol and Artesunate-Mefloquine in

Treatment of Multidrug Resistant Falciparum Malaria Antimicrobial

Agents and Chemotherapy 42[1] Jan 1998 135-139

210 Price RN Uhlemann AC van Vugt M Brockman A Hutagalung R

Nair S Nash D Singhasivanon P Anderson TJ Krishna S White NJ

Nosten F Molecular and pharmacological determinants of the

therapeutic response to artemether-lumefantrine in multidrug-

resistant Plasmodium falciparum malaria Clin Infect Dis 42[11] 1

Jun 2006 1570-7

211 Zurovac D Ndhlovu AKRowe DH Hamer DMThea and

RWSnow Treatment of paediatric malaria during a period of drug

transition to artemether-lumefantrine in Zambia Cross sectional

study BMJ 2005 331-734

212 De Beule K and Van Gestel J Pharmacology of Lumefantrine Drugs

61[S1] 2001 27-37

213 Conway SP Etherington C Peckham DG Brownlee KG Whitehead A

and Cunliffe H Pharmacokinetics and safety of Lumefantrine in

patients with cystic fibrosis Journal of Antimicrobial Chemotherapy

53 2004 841-847

214 Lefevre G Carpenter P Souppart C Schimidli H McClean M

Stypinski D Pharmacokinetics and electrocardiographic

pharmacodynamics of artemether-lumefantrine [Riamet] with

concomitant administration of ketoconazole in healthy subjects Br J

Clin Pharmacol 54[5] Nov 2002 485-92

215 Ter KF NJ White PHolloway GPasvol and SKrishna Plasmodim

falciparum in vitro studies of the pharmocodynamic properties of

drugs used for the treatment of severe malaria Exp Parasitol 76

1993 85-95

216 CHatz SAbdulla RMull DSchellenberg IGathmann Pkibatala

HPBeck MTanner CRoyce Efficacy and safety of CGP 56697

[artemether and benflumetol] compared with chlroquine to treat acute

falciparum malaria in Tanzanian children aged 1-5 years Tropical

Medicine and Interantional Health 3 1998 498

217 MV Vugt P Wilairatana B Gemperli I Gathmann L Phaipun A

Brockman C Luxemburger NJ White F Nosten and S

Looareesuwan Efficacy of six doses of artemether-lumefantrine

[benflumetol] in multidrug-resistant Plasmodium falciparum malaria

Am J Trop Med Hyg 60[6] 1999 936-942

218 Danielle Colussi Carole Parisot Francois Legay and Gilbert Lefegravevre

Binding of artemether and lumefantrine to plasma proteins and

erythrocytes European Journal of Pharmaceutical Sciences 9[1] Oct

1999 9-16

219 Annerberg A Singtoroj T Tipmanee P White NJ Day NP Lindegardh

N High throughput assay for the determination of lumefantrine in

plasma J Chromatogr B Analyt Technol Biomed Life Sci 822[1-2] 5

Aug 2005 330-3

220 N Lindegardh A Annerberga D Blessborn Y Bergqvist N Day

and NJ Development and validation of a bioanalytical method using

automated solid-phase extraction and LC-UV for the simultaneous

determination of lumefantrine and its desbutyl metabolite in plasma

White Journal of Pharmaceutical and Biomedical Analysis 37[5] 29

Apr 2005 1081-1088

221 CAHovinga Levetiracetam a novel antiepileptic drug

Pharmacotherapy 21[11] 2001 1375-88

222 EA Wilson MJ Brodie New antiepileptic drugs Baillieres Clin

Neurol 5[4] 1996 723-47

223 William E Rosenfelda Selim Benbadisb Pascal Edrichc Carlo

Alberto Tassinarid Edouard Hirsche Levetiracetam as add-on

therapy for idiopathic generalized epilepsy syndromes with onset

during adolescence Analysis of two randomized double-blind

placebo-controlled studies 85[1] Jul 2009 72-80

224 E Perucca M Bialer The clinical pharmacokinetics of the newer

antiepileptic drugs Focus on topiramate zonisamide and tiagabine

Clin Pharmacokinet 31[1] 1996 29-46

225 Eric Snoecka Philippe Jacqmina Maria Laura Sargentini-Maierb

Modeling and simulation of intravenous levetiracetam

pharmacokinetic profiles in children to evaluate dose adaptation

rules 76[2] Sept 2007 140-147

226 Nathan B Fountaina Joan A Conryb Ildefonso Rodriguez-Leyvac

Juvenal Gutierrez-Moctezumad Edubijes Salase Rene Coupezf

Armel Stockisf Zhihong [Sarah] Lue Prospective assessment of

levetiracetam pharmacokinetics during dose escalation in 4- to 12-

year-old children with partial-onset seizures on concomitant

carbamazepine or valproate 74[1] Apr 2007 60-69

227 N Isoherranen B Yagen S Soback M Roeder V Schurig and

MBialer Pharmacokinetic analysis of levetiracetam and its

enantiomer R-alpha-ethyl-2-oxo-pyrrolidine acetamide in dogs

Epilepsia 42 2001 825-830

228 R Coupez R Straetemans G Sehgal A Stockis ZS Lu J

Levetiracetam relative bioavailability and bioequivalence of a 10

oral solution [750 mg] and 750-mg tablets ClinPharmacol 43[12]

2003 1370-6

229 Ganesan M Rauthan SK Yadav SS Pandey Y tripathi P

Validated liquid chromatographic ultra violet method for the

quantization of levetiracetam in human plasma using liquid-liquid

extraction International journal of pharmaceutical sciences and

research [IJPSR] 1[1] 2010 1-9

230 TA Vermeij PM Edelbroek High-performance liquid

chromatographic and megabore gas-liquid chromatographic

determination of levetiracetam [ucb L059] in human serum after

solid-phase extraction J Chromatogr B Biomed Appl 662[1] 2 Dec

1994 134-9

231 Jens Martens-Lobenhoffer Stefanie M Bode-Boger Determination of

levetiracetam in human plasma with minimal sample pretreatment

Journal of Chromatography B 819 2005 197-200

232 N Isoherranen M Roeder S Soback B Yagen V Schurig MBialer

Enantioselective analysis of levetiracetam and its enantiomer R-alpha-

ethyl-2-oxo-pyrrolidine acetamide using gas chromatography and ion

trap mass spectrometric detection J Chromatogr B Biomed Sci Appl

745[2] 18 Aug 2000 325-32

233 Pitt B Konstam MA Overview of angiotensin II Am J Cardiol 82

1998 47-49

234 Unger T Significance of angiotensin type 1 receptor blockade why

are angiotensin II receptor blockers different Am J Cardiol 84 1999

9-15

235 Willenheimer R Dahl B Rydberg E Erhardt L Angiotensin II receptor

antagonists Eur Heart J 20 1999 997-1008

236 Zhang P Zhang Y Chen X Li R Yin J Zhong D Pharmacokinetics of

telmisartan in healthy Chinese subjects after oral administration of

two dosage levels Arzneimittelforschung 56 2006 569-73

237 Ebner T Heinzel G Prox A Beschke K Wachsmuth H Disposition

and Chemical Stability of Telmisartan 1-O-Acylglucuronide Drug

Metab Dispos 27 1999 1143-1149

238 Chen B Liang Y Wang Y Deng FL Zhou P Guo F and Huang L

Determination of telmisartan in human blood plasma Part I

Immunoassay development Anal Chim Acta 540 2005 367-373

239 Torrealday N Gonzalez L Alonso RM Jimenez RM Lastra EO

Determination of telmisartan in human blood plasma J Pharm

Biomed Anal 32 2003 847-857

240 Maotian TX Song JF Li N Determination of telmisartan in human

blood plasma Anal Bioanal Chem 377 2003 1184-1189

241 Maotian TX Song J Liang Y Determination of telmisartan in human

blood plasma J Pharm Biomed Anal 34 2004 681-687

242 Kondo T Yoshida K Yoshimura Y Motohashi M Tanayama S

Characterization of Conjugated Metabolites of a New Angiotensin II

Receptor Antagonist Candesartan Cilexetil in Rats by Liquid

ChromatographyElectrospray Tandem Mass Spectrometry Following

Chemical Derivatization J Mass Spec 31 1996 873-878

243 Gonzalez L Akesolo U Jimenez RM Alonso RM Determination of

telmisartan in human blood plasma Part II Liquid chromatography-

tandem mass spectrometry method development Comparison to

immunoassay and pharmaco kine -tic study Analytica Chimica Acta

560 2006 41-49

244 Yan T Li H Deng L Guo Y Yu W Fawcett JP Zhang D Cui Y Gu J

Liquid chromatographic-tandem mass spectrometric method for the

simultaneous quantitation of telmisartan and hydrochlorothiazide in

human plasma J Pharm Biomed Anal 48 2008 1225-9

245 Ferreiros N Dresen S Alonso RM Weinmann W Validated

quantitation of angiotensin II receptor antagonists [ARA-II] in human

plasma by liquid-chromatography-tandem mass spectrometry using

minimum sample clean-up and investigation of ion suppression Ther

Drug Monit 29 2007 824-34

246 Li P Wang Y Wang Y Tang Y Fawcett JP Cui Y Gu J

Determination of telmisartan in human plasma by liquid

chromatography-tandem mass spectrometry J Chromatogr B Analyt

Technol Biomed Life Sci 828 2005 126-9

247 ACrosignani KDSetchell PInvernizzi ALarghi CMRodrigues

MPodda Clinical pharmacokinetics of therapeutic bile acids Clin

Pharmacokinet 30[5] 1996 333-58

248 SScalia RScagliarini PPazzi Evaluation of ursodeoxycholic acid

bioavailability from immediate- and sustained-release preparations

using gas chromatography-mass spectrometry and high-performance

liquid chromatography Arzneimittelforschung 50[2] Feb 2000 129-

34

249 SScalia PGiunchedi PPazzi UConte Enhancement of

ursodeoxycholic acid bioavailability by cross-linked sodium

carboxymethyl cellulose J Pharmacy and Pharmacology 52[4] Apr

2000 383-388

250 AKBatta SShefer MBatta GSalen Effect of chenodeoxycholic acid

on biliary and urinary bile acids and bile alcohols in cerebrotendinous

xanthomatosis monitoring by high performance liquid

chromatography Journal of Lipid Research 26[6] 1985 690-698

251 MNobilis MPour JKunes JKopecky JKvetina ZSvoboda

KSladkova JVortel High-performance liquid chromatographic

determination of ursodeoxycholic acid after solid phase extraction of

blood serum and detection-oriented derivatization JPharm Biomed

Anal 24[5-6] 2001 937-47

252 FNakayama MNakagaki Quantitative determination of bile acids in

bile with reversed-phase high-performance liquid chromatography

JChromatogr 183 [3] 1980 287-93

253 WSwobodnik UKluppelberg JGWechsler MVolz GNormandin

HDitschuneit Rapid and accurate reversed-phase high-performance

liquid chromatographic determination of conjugated bile acids in

human bile for routine clinical applications Therapeutic control

during gallstone dissolution therapy JChromatogr 339[2] 1985

263-71

254 RGatti ARoda CCerre DBonazzi VCavrini HPLC-Fluorescence

determination of individual free and conjugated bile acids in human

serum Biomedical Chromatography 11[1] 1997 11-15

255 VCavrini RGatti ARoda CCerre PRoveri HPLC-fluorescence

determination of bile acids in pharmaceuticals and bile after

derivatization with 2-bromoacetyl-6-methoxynaphthalene J Pharm

Biomed Anal 11[8] 1993 761-70

256 ESLianidou DSPapastathopoulos PASiskos Determination of

ursodeoxycholic acid in serum by a new fluorometric enzymatic

method using 7β-hydroxysteroid dehydrogenase from Clostridium

absonum Analytical Biochemistry 179[2] 1989 341-346

257 JGoto KWatanabe HMiura TNambara TLida Studies on

steroids CCXXVIII Trace analysis of bile acids by gas

chromatography-mass spectrometry with negative ion chemical

ionization detection J Chromatogr 388[2] 1987 379-87

258 AKBatta RArora GSalen GSTint DEskreis SKatz

Characterization of serum and urinary bile acids in patients with

primary biliary cirrhosis by gas-liquid chromatography-mass

spectrometry effect of ursodeoxycholic acid treatment Journal of

Lipid Research 30[12] 1989 1953-1962

259 KKuriyama YBan TNakashima TMurata Simultaneous

determination of biliary bile acids in rat Electron impact and

ammonia chemical ionization mass spectrometric analyzes of bile

acids Steroids 34[6] 1979 717-728

260 ARoda CCerre PSimoni CVaccari APistillo Determination of free

and amidated bile acids by high-performance liquid chromatography

with evaporative light-scattering mass detection Journal of Lipid

Research 33[9] 1992 1393-402

261 SPerwaiz BTuchweber DMignault TGilat IMYousef

Determination of bile acids in biological fluids by liquid

chromatography-electrospray tandem mass spectrometry Journal of

Lipid Research 42[1] 2001 114-9

260 ARoda CCerre PSimoni CVaccari APistillo Determination of free

and amidated bile acids by high-performance liquid chromatography

with evaporative light-scattering mass detection Journal of Lipid

Research 33[9] 1992 1393-402

261 SPerwaiz BTuchweber DMignault TGilat IMYousef

Determination of bile acids in biological fluids by liquid

chromatography-electrospray tandem mass spectrometry Journal of

Lipid Research 42[1] 2001 114-9