pet syllabus for bioanalytical sciences...page pharmacognosy subtopics: 1....
TRANSCRIPT
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PET SYLLABUS
FOR BIOANALYTICAL SCIENCES
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Proprietaryformulation
7. IntroduceAyurvedicandSiddhaFormularyofIndiaandAyurvedicand
SiddhapharmacopoeiaofIndia
8. IntroductiontotheconceptsofSiddha
Modern
MedicineSubtopi
cs:
1. Principlesandpractice
2. APIandconceptofits formulationintoadosageform
3. Different typesDrugFormulations
4. Excipientsinvariousdosageforms
5. DiseaseManagement(ComparisonofASUandModernDrugs)withresp
ecttotheirmodeofaction
a. Diabetes b. Tuberculosis
c. Hypertension
d. Hepatitis
e. Malaria
f. Dengue
g. Influenza
h. Cancer(Chemotherapy andImmunotherapy)
Indiansystems ofMedicine(ASU)–
Ayurveda,Siddha&UnaniSubtopics:
1. Principlesandpracticew.r.t.ASU
2. TypesofDrugFormulationw.r.t. ASU
3. MethodsofManufacture–RawMaterial toFinishedProductw.r.t.ASU 4. Types of Drug w.r.t.ASU 5. Excipientsinvariousdosageform 6. Introduce concept of Classical Ayurvedic formulation and
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Pharmacognosy
Subtopics:
1. BasicConcept,History,Scope&CurrenttrendsinPharmacognosy
2. Crude Drugs: basic concept, classification- depending on their
origin& importance (to include Plants and their medicinal uses with
any 10examplesincludingfew ethnobotanicallyimportantplants)
3. Collection,storage,deterioration&adulterationofcrudedrugs
4. Evaluationofcrudedrugs(withreferencetomonographs)
5. Herbariaintroduction
6. Ethnobotany:basic concept,definition,historyandimportance
7. Cultivationofmedicinalplants:advantagesofcultivatedplants,GoodAgr
iculturalPractices,GoodHarvestingPracticesanddocumentation
PrincipleofextractionandIsolationofanalytes
Subtopics: 1. ImportanceofExtraction
2. Physico-chemicalpropertiesofSolutesand solvents
3. Conceptofpartition&PartitionCoefficient
4. Solventproperties
5. Selectionofsolvent
6. Introduction toclassical
methodsofextractionandmodernmethods ofextraction-
advantages &disadvantages
7. Includese.g.
LLE,LME,SPE,MAE,UAE,SFE,SPME,Soxhwave
8. Applicationsofextraction
9. Ionizationanditseffectontheextractionofdrugs
10. The‘Firstlaw ofdrugmetabolism’
11. Matrixcomponents&analyteisolation
12. Concentrationofextracts
13. Isolations offractions
14. Purificationofisolate
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6. Calibrationrecords
7. SignificanceofvalidationincGLP
8. Transferofmethods
9. Documentation
10. cGLPCertification
11. GeneralPrecautions,labelsandsignage’s
12. Personalsafety&Clothing
13. Levelsofsafety
14. Firesafetyandfirefighting
15. OSHAguidelines
PharmacopoeialstandardsandTestingProcedure
Subtopics:
1. Introduction toWHOguidelinesandICHguidelines
2. IntroductiontoISOandCE
3. Introduction to Pharmacopoeias IP, BP, USP (JP, EP where everapplicable)
4. Specified test in Monographs w.r.t liquid formulation(injectable)and solid dosageform(USP,
EP, BP,IP)
DrugAct&Regulations
Subtopics:
1. IndianDrugs
andCosmeticsActw.r.tScheduleY,M,H.IncludeScheduleA,S(introduction)withamendments.
2. Introductiontoforeignguidelinesw.r.tUS,EU,Australia&Japanwith amendments.
3. IntroductiontoCFR21part11withamendments.
GoodLaboratoryPractice(GLP)
Subtopics:
1. Whatis cGLP?
2. PracticingcGLP
3. GuidelinestocGLP
4. GoodLaboratoryPractices:GeneralProvisions,OrganizationandPersonnel, Facilities, Equipment, Testing
Facilities Operation,Test and Control Articles, Protocol for Conduct of a
NonclinicalLaboratoryStudy,DisqualificationofTestingFacilities 5. PreparationofSOPs
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QualityControl(QC)andQualityAssurance(QA)
Subtopics:
1. QualityControl,QualityAssuranceandQualityManagementconcepts:Definition andconcept
2. Total Quality Management (TQM): Definition, elements,philosophies
3. Brief overview of QSEM, ICH guidelines with special emphasisonQ-series
4. Qualitybydesign(QbD):Definition,overview,elementsofQbD program,tools.ICH guidelines section8-
12.
5. QC&QA ofModerndrugs andASU drugs-introduction 6. Organization andpersonnel:Personnelresponsibilities,training,hygieneand personalrecords. 7. Auditrequirements 8. Documentmaintenance inpharmaceuticalindustry:Batch
TheoryofChromatographicseparationandTLC
Subtopics:
1. Principlesofchromatographicseparation
2. Introduction tochromatographicseparationtechniques
3. PrinciplesandPracticeofTLC
4. UsesofTLC
5. Somerecommendedsolvents systems
6. DetectionofcompoundsonTLC plates
7. IntroductiontoHPTLCanditsapplications
8. RecentadvancesinTLC
HPLC– 1
Subtopics: 1. PrinciplesandInstrumentation 2. Thechromatographicprocess
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3. Thechromatogram
4. Separationmode
5. Columnchemistry
6. Systemparameters
7. Introduction tovariousHPLCtechniques;
a. Normalphase
b. Reversephase
c. Ion-pairHPLC
d. Ion-exchangeHPLC
e. GelpermeationChromatography
8. HPLCdetectors
a. Introduction
b. Principlesofdetection
c. UniversalandSpecific
d. Detectors
e. Detectorresponse
f. Sensitivityconsiderations
g. Selectivity
9. IsocraticandGradientHPLC
10. ApplicationsofHPLC
11. Recentadvances(FastLC,online extractions,addonpumps,onlinederivatization, multi-dimensionalLC)
GC–I
Subtopics: 1. PrinciplesandInstrumentation
2. Factors that affect the chromatographic separation (Temperature,Typeof columnetc.)
3. GCtechniques 4. Typesofcolumnsand theirapplication
5. Selection of liquid stationary phases (Packed and capillarycolumns)
6. GChardware 7. Introduction toflowandpressurecontrollers
8. Injectiontechniques-oncolumninjection,largevolumeinjection,split -split less, PTV and various auto
injectors- gas sampling aswellasliquidsampling
9. Column Oven- temperature programming, (High /cryogenicoventemperature)
10. Universal and specific Detectors in GC (FID, TCD, ECD, FPDand NPD)
Spectroscopy–I
Subtopics:
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1. Introduction toatomicandmolecularSpectroscopy
2. UV,Visibleand fluorescence
a. Principle,Instrumentation
b. Applications
3. NephelometryandTurbidometry
a. Principle,Instrumentation
b. Applications
4. IRandRamanSpectroscopy
a. Principle,Instrumentation
b. Applications
5. Introduction andApplicationofATR
6. NMR
a. Principle,Instrumentation
b. Applications
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3. Overviewofproteomics
a. Methodsforcelldisruption/proteinextraction
b. Proteinpurification/Fractionation
c. Proteinidentificationandcharacterization
4. Posttranslational(invivo) and Chemical(invitro)
modificationsofProteins
Electrophoresis
Subtopics:
1. BasicProteinChemistry
2. Principlesofelectrophoreticseparation
3. Equipmentandprocess
4. Agarosegelelectrophoresis
5. PAGE – Native & SDS, 2DGE, Extensions of Electrophoresis-
Immunoelectrophoresis/pulsefield
6. Standardizationof electrophoretictechnique 7. Detectiontechniquesshouldalsoincludeblottingtechniques
8. Applicationsofelectrophoresis
Bioinformatics
Subtopics:
1. Whatisbioinformatics?
2. DatabasesandSearchTools
3. Applicationsofbioinformatics
a. Genomics
b. Proteomics
c. Drugdiscovery(Dockingsoftware)
d. Otherinsilicomethods
4. Using various libraries & tools w.r.t structure/ literature to
drugdevelopment/proteins 5. Introductionto Chemi-informatics
Title
OMICS
Subtopics:
1. IntroductiontoOmics:
a. Genomics
b. Proteomics
c. Metabolomics d. Lipidomics
2. SignificanceofGenomeand proteome
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EnvironmentalIssuesofBioanalytical laboratory
Subtopics:
LaboratoryWaste:Management,controlandRegulatoryissues
1. IntroductiontotypesandsourcesofLaboratorywaste
2. Chemical&Biologicalmaterials:HazardsandHandling
3. HazardControls&Information(WorkplaceHazardousMaterialsInf
ormationSystem{WHMIS}asexample)
4. Introductionto: a. ChemicalStorageandSegregation b. ChemicalLaboratoryEmergencyResponse
c. EquipmentSafety
d. LaboratoryInspections
e. TransportationandReceivingofHazardousMaterials
5.RegulationsofPollutionControlBoardforLaboratories.
RandDinPharmaindustryandRecenttrendsinIndianPhar
maceuticalindustry– I
Subtopics:
1. HistoricalbackgroundwithemphasisonPost1947period
2. MagicRemedyAct
3. Markettrendsandactivities 4. Govt.initiativesandthe publicsector inPharmaceuticalIndustry 5. TheroleofDrugPricingpolicyinIndiaandits impactonthe
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IndianPharmaceuticalIndustry
6. PharmaR&Dandtheirstrategies
7. Concept ofNCE andnewdrugdevelopment onBiosimilars,MABs
andPhytochemicals
8. Bioassays- Introduction (Principle, purpose and types -invitro,
invivo), Qualitative and Quantitative with examples,
advantagesanddisadvantages
SPE,SCFE
Subtopics:
1. SPE
a. Introduction
b. Generalpropertiesofbondedsilicasorbents
c. Sorbent/analyteinteractions
d. Samplepretreatmentof differentbiologicalmatrices
e. DevelopingSPEmethodswithexample
f. Othernewdevelopments
2. SCFE,
a. Concept
b. Instrumentation
c. Factorsaffecting
d. OnlineSCFE
e. Automationinextraction
f. QuenchersMethodsofextraction
g. AdvantagesandDisadvantages
h. Applicationfornaturalproducts
i. -Futureperspectives
Phytochemistry
Subtopics:
1. Naturaldrugsubstancesfromplants(primaryandsecondarymet
abolites)
2. Broadclassificationofsecondarymetabolites
a. Nitrogenous
b. Non-nitrogenous
c. Isoprenoids
3. Secondary drug metabolite production with special
referencewithintegrated pathway
4. KeyFactorsaffectingsynthesisofsecondarymetabolites
5. ExtractionTechniquesofCrudeplantmaterial
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RandDinPharmaindustryandRecenttrendsinIndianPhar
maceuticalindustry– II
Subtopics:
1. Introduction to Biopharmaceuticals andpharmaceuticalbiotechnology.
2. Biopharmaceuticals:currentstatus andfutureprospects
3. Genericandbrandedbiopharmaceuticals
4. Overviewoflifehistoryfordevelopmentofbiopharmaceuticals.
5. Discoveryofproteinorpeptidebasedtherapeutics:
a. In-silico
b. Pharmaco-informatics.
6. Pre-clinicaltoxicityassessment
7. Clinicaltrial phasesanddesign
8. Clinicaldatamanagement
9. ConceptofPharmacovigilance
IPRandPatenting-I
Subtopics:
1. ConceptofIPR-
UnderstandingthemeaningofIPR&itssignificancein knowledge-
based economy.
2. Types of IPR - Patents, Trade Marks & Service Marks,
DesignRegistration, Trade Secrets, Geographical indications,
ProtectionofNewPlantVarieties,Copyright.
3. Global Harmonization - Impact of IPR on global trade and
theneedforharmonization,WTOanditsroleinaglobalharmonization
, TRIPS and introduction to the articles in TRIPsdocument.
4. InternationalAgreementsrelatedtoIPR&patents-
ParisConvention,PCT, BudapestTreaty,UPOV
StabilityStudies
Subtopics:
1. Factorsthat influencestabilityofdrugformulations
2. TypesofStabilitychambersandtheirdesignconsiderations
3. StabilityissuesofASUrawmaterialsandfinishedproducts
4. Accelerated methods, Shelf Life determination of
Drugsubstances and Drugproducts.
5. WHOandICHguidelinesforstabilitytesting
6. ApproachestostabilitystudiesofASUformulations
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IPRandPatenting-2
Subtopics:
1. IndianPatentAct–
a. Criteria to be fulfilled for Patentability- new/novel, non-
obvious/inventivestep,useful/capableofindustrialapplication. b. Non-patentablesubjectmatter -whatisnotpatentable. c. ConceptofMailboxandEMRandhowithashelpedIndiainits
transition tofullTRIPScompliance.
d. How India has leveraged the flexibilities provided by
TRIPStosafeguardtheindustryandpreventever-
greeningofpatents.
e. ProvisionalPatents,DivisionalPatents&PatentsofAddition.
2. IPRas astrategictool–
a. Role of patentee and patent offices in patent
managementincluding lab documentation, confidentiality
agreements, pre-andpost-grantopposition,servicing ofpatents.
b. Conceptsofpiracy,reverseengineeringandknowledgeworker.
c. Benefitsofcreatingand/orowningPatentsandotherIPR.
d. IPclearance–
Precautionsbeforelaunchingofproductanywherein theworld
e. Basics of Patent Searching, Introduction to Patent
Databases,ConceptsofFreedomtooperate(FTO)searchandanal
ysisforpatents,Exclusivity andSPC statuscheck
f. OtherIPRchecksliketrademarks,copyrights(forprinteddataonl
eaflets, packagesetc.),
g. Putting IPR related disclaimers while advertising product
listorsellingproducts.
PackaginginPharmaindustry
Page
Subtopics:
1. IntroductiontoPackaging
2. FundamentalsofDistribution
3. PackagingForms&theirSignificance
4. PackagingMaterials(coveringbasicmanufacturingprocess,ap
plications andsignificance)
5. Paper, Paper Board and CFB Glass, metals, Basic Polymer
basedmaterials,Polymerbased compositematerials
6. AncillaryMats
7. PackageMaterialTesting
8. Compatibility&MigrationStudies
9. AcceleratedShelf Life Testing -TheoryandProblems.
10. cGMP
11. PackagingValidation
12. PackagingLawsandregulatorycompliance
HPTLC
Subtopics:
1. PrinciplesandInstrumentation
2. HPTLCvs TLC
3. Densitometry &quantitationin HPTLC
4. HPTLCinfingerprinting&QC
5. Troubleshooting
6. ApplicationsofHPTLC
7. RecentadvancesinHPTLC
HPLC–II
Subtopics:
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1. ChiralHPLCanditsadvantages
2. ColumnswitchinginHPLC
3. Columnconditions
4. Automation inHPLC
5. UPLCand2DLC
a. PrincipleandInstrumentation
b. Application,Advantagesanddisadvantages
6. HPLCdetectors
a. Radiometricdetectors
b. MALSdetector
7. SCFC
a. PrincipleandInstrumentation
b. Factorsaffecting
c. Application
d. Advantagesanddisadvantages
8. ManualandElectronicDataProcessing
9. Troubleshooting
GC–II
Subtopics:
1. Pyrolizer
2. DerivatisationforGC
3. HeadSpaceGC
4. 2DGC/GC-GC
5. GCstrategyforanalysis involvingbiologicalmatrices
6. Troubleshooting
7. Applications
Spectroscopy–II
Subtopics:
1. Emissionspectroscopy
2. CircularDichroism(CD)andOpticalRotaryDispersion(ORD)
a. Principle,Instrumentation
b. Application
3. FlamePhotometryandAtomicEmissionSpectroscopy
a. Principle,instrumentation
b. Applications
4. AAS
a. Principle,Instrumentation
b. Applications
5. ICP
a. Principle,Instrumentation
b. Applications 6. X –raydiffraction/X-rayFluorescence
a. Principle,Instrumentation
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b.Applicationsshouldincludepolymorphism
7. C-13 NMR and2DNMR
a. Principle,Instrumentation
b. Applications
NCEandits developmentintoaNew DrugandEnzymes
Subtopics: 1. Drugdiscoveryanddevelopment 2. Detaileddescriptionofitsvariousstagesinitsdiscoveryand
developmentofNCE
3. Introduction andapplicationsofenzymes
4. Definition,Classification,Nomenclature,ChemicalNature,Properti
es of Enzymes, Mechanism of Enzyme Action, ActiveSites,
Enzyme Specificity, Effect of pH, Temperature,
SubstrateConcentration on Enzyme Activity, Enzyme Kinetics,
Michelis -MentenEquation,TypesofEnzymeInhibitions-
Competitive,Uncompetitive,Non-
CompetitiveAllostericModulatorsCo-Factors,Zymogens
5. Enzyme as Therapeutics agents, as diagnostics, as catalyst
inprocesses asdrugtarget
Immunoassay&ELISA
Subtopics:
1. Immunoassay:
a. Introduction
b. Reagentsrequiredforimmunoassaydevelopment
c. Basicmethodologyinvolvedinpharmaceuticalanalysis
d. Immunoassaymethodsappliedinpharmaceuticalanalysis
- Radioimmunoassay
- Enzymeimmunoassay
- Fluoroimmunoassay
- Chemiluminescenceimmunoassay
- Liposomeimmunoassay
2. AdvancesinImmunoassaysforpharmaceuticalanalysis
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BasicPharmacokinetics,PharmacodynamicsandDrugproperties
Subtopics:
1. BasicconceptsofPharmacokinetics&pharmacodynamics
2. Differentpharmacokinetic&pharmacodynamicsparametersandthe
irmeanings
3. Basic techniques of evaluating Pharmacokinetic
andpharmacodynamicsparameters
4. Basic types of models in pharmacokinetics
&pharmacodynamics
5. General classificationofDrugsandtheirformulations 6. Physicochemicalpropertiesof drugsaffectingADME
7. ConceptsofDrugMetabolism&eliminationwithexamples
8. AdverseDrugreactions(ADRs)
9. SeriousAdverseEvents(SAEs)
LaboratorySafetyMeasuresw.r.thandlingofchemicalsandbiol
ogicalmaterials
Subtopics:
1. Materialhandlinganddisposal
2. TheNewSafetyDataSheets(SDS),
MaterialSafetyDataSheets(MSDS)andSOP(StandardOperatingP
rocedure)
3. WorkinginBiosafetyCabinetsandhoods
4. Levelsofsafety
5. Safedisposalofinfectiouslaboratorywaste.
BasicMicrobiologyanditsapplicationinpharmaceuticals
Subtopics:
1.Microbes & Their environment, Significance and scope of
Microbiology, Biodiversity and types of Microorganisms,
Visualization of Microorganisms: staining and Simple and
compoundmicroscopy,Electron Microscopy
2. GrowthofMicroorganisms,methodstostudygrowthofmicroorganisms,p
reservationofmicroorganisms,maintenancemedia,etc
3. Sourcesofantimicrobialagents:plantsandmicroorganisms,therapeuticA
ntimicrobialAgentsE.g.Erythromycin,AmphotericinB,Cephalosporins
and their commercial production, Antimicrobial DrugResistanceand
DrugDiscovery
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Genomics
Subtopics:
1. NucleicAcidchemistry
2. PrinciplesofDNAsequencing
3. DNA&RNAprobes
4. ConceptsofGenemanipulation(introductiononly)
5. Restrictionenzymes&theiruses
6. Vectors&theiruses
7. ProducingTransgenicorganisms
8. Hybridomatechnology
9. cDNAproduction&applications
10. Genelibraries&applications
BasicandRegulatory Toxicology
Subtopics:
1. Introduction,scopeandtypesoftoxicologicalstudies.
2. Toxicants,theirrouteofentry,distribution
3. Metabolism&eliminationoftoxicants
4. ConceptofLD50,ED50Title:RegulatoryToxicology
5. Typesoftoxicitystudies
6. Designconsiderations.
7. Evaluationofresults
8. Extrapolationtoman.
9. OECDGuidelinesonToxicologicalstudies
10. ScheduleYanditsinterpretation.
RegulatoryMicrobiology anditsapplication
inpharmaceuticalandfoodindustry
Subtopics:
1.Asepsis,SterilizationandDisinfection,conceptofDeathcurveof
microbialpopulation,Asepticfillinginpharmaceuticalindustry,
Classification Clean rooms / Clean areas, QA and QC
inMicrobiologyLaboratory
2. Important Microbes for Food & Drug Industry,
PathogenicOrganisms in Food &PharmaIndustry
3. Sources of contamination, Microbial Contamination in
ASUpreparations
4. RegulatoryMicrobiologicaltestinginpharmaceuticals
5. MicrobiologicalAssaysforpharmaceuticalproducts
1. Desk
Page
MSbasics
Subtopics:
1. Theory
2. Components
a. Inlet(Direct,membrane,insertionprobes,etc.)
b. Ion sources (EI, CI, FAN, Thermospray, particle beam,
ESI,APCI,APPI, MALDI,etc.)
c. Analysers (Magnetic sector, Quadrupole, Ion Trap, TOF, FT-
ICR,Orbitrap, etc.) d. Detectors(Electronmultiplier,photomultiplier, Faradaycup,
Microchannelplate,etc)e
.Vacuumsystem
3.MS/MS (TQ,IonTrapandHybrid)
Hyphenation
Subtopics:
1. LC-MSandLC-MS/MS
2. HeadspaceGC,GC-MSand GC-MS/MS(e.g.essentialoils)
3. ICP-MS
4. ScaneventsinTQandothertandem systemsandhybridsystems
5. Recent advances in MS systems (TLC-MS, DART,
DESI,SELDI,etc)
Thermalanalysis
Subtopics:
1.Principle,instrumentationandworkingofTGA,DTAandDSC2.Appl
ications of thermal analysis (including analysis of Bhasma)
3.Recentadvances- hotstagemicroscope
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Title:Particlecharacterization
Subtopics:
Usingsuitabletechniquesanalyze:1.
Size 2. Shape 3. Surfacearea
4. Distribution
5. Porosity
6. Rheology
StandardizationofASUdrugs
Subtopics:
1. NeedofstandardizationofAyurvedic drugs
2. Whatdoesstandardizationinvolve?
3. Bioanalyticaltoolsforstandardization
4. ClinicalstudiesinStandardization
5. Approachestostandardization;
6. Rawmaterials
7. In-processmaterials
8. Finishedproducts 9. DevelopingstandardizedQCmethods 10. Shelflife studiesonfinishedproducts
GeneralStatisticalMethods
Subtopics:
1. Basicconceptsofsamplestatistics
2. Conceptofsamplesizeandpower
3. Conceptofrandomisationandsampling techniques
4. Conceptofsignificanceandconfidencelimits
5. Introduction to Various statistical tests - parametric and non-
parametric 6. UseofStatisticalPackagesforDataevaluation
7. Conceptofrandomsamplingandsamplingtechniques
8. Conceptoflevelof significance, power of
testandconfidencelimits
9. Conceptofsamplesize 10. Applicationofnormaldistribution
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ConceptsofBiostatistics
Subtopics:
1. Statisticalapproachtobiologicalsamples
2. Variationsinbiologicalsamples& theirstatisticaltreatment
3. IntroductiontoDatacollectiontechniques
4. Designofexperimentswitheg.Blockdesigns,Latinsquare
5. COV and ANOVA
6. Student’sttestandFtest
7. Regressionanalysiswith applicationtoStdGraph
8. Non-parametrictestswithexamples
9. StatisticalGuidancefromregulatoryagencies
10. Student’sTtest,chisquaretest,Z testandFtest
11. SinglesampleandtwosampleNon-
parametrictestswithexamples
12. Useofstatisticalpackagesfordataanalysis(SPSSsoftware)
CurrentGoodManufacturingPractices(cGMP)
Subtopics:
1. Whatis cGMP?
2. Requirements of
cGMPimplementation3.Documentationofc
GMPpractices
4.Regulatory certification of
cGMP5.cGMPinproductionofASUdr
ugs
6. HarmonizationofSOPof manufacture 7. AuditforcGMPcompliances
GoodClinicalPractices(GCP)
Subtopics:
1. OriginofEthicalIssues
2. Ensuringcompliancetoethicalissues3.
EthicalCommittees &theirsetup
4. Regulatory powers of ethical
committees5.Ethicalissuesinanimalstudies
6. DealingwithEthicalissues(subjectcompensationandsubjectrigh
ts) 7. Compliancetocurrentethicalguidelines
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8. What is
GCP?9.OriginofG
CP
10. EarlierGuidelinesforGCP
11. RequirementsofGCPcompliance1
2.GCPguidelinesofICH
13.GCPguidelinesofICMR14
.Ensuring GCP
15. Documentation of
GCP16.AuditofGCPcomplia
nce
Research
MethodologySubtopics
:
1. Basicsofresearchand itstypes
2. Use of digital platforms for
research3.Reviewofliterature 4. Reportwriting 5. Ethicalissues
6. Patentofresearch
7. How to propose and write a research project and information
offundingagencies
AnalyticalMethodValidation
Subtopics:
1. StrategiesforMethoddevelopment
2. WhatandWhyofmethodvalidation
3. Regulatoryrequirementsofvalidation
4. IQ,OQandPQofanalyticalinstruments
5. UseofReferencestandards
6. IssuesofMethod transfer
7. Intraandinterlab –Validation
8. Samplingmethods
9. Calibration of glassware and instruments, concepts of
GoodWeighingPractice
10. UseofReferencestandardsandworkingstandards
11. formatofCertificateof Analysis
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BioanalyticalMethodValidation
Subtopics:
1. Validation
2. Guidelines 3. Validationparameters 4. Validationexperiment
Page
5. Incurred sample
reanalysis6.Validation
protocol
7. Documentationandreporting
8. Need for blood stability in method
validation9.Freeze&thawstability
10.Inter&intradayprecisionandaccuracyanalysis.
BioassaysinPharmaceuticalevaluation
Subtopics:
1. General idea about bio assay systems used in
pharmaceuticalevaluations
2. Invitroassaysandinvivoassays
3. Ethicalissuesofusinganimalassaysystems
4. Alternativestoanimalassays–oneortwoexamples
5. PharmacopoeialBioassays-IP
PolymeraseChainReaction(PCR)&DNAFingerprinting
Subtopics:
1. TypesofPCR&itsapplications
2. DNAamplificationw.r.titsapplications
3. DNAfingerprintingandapplications
4. Useofgenomictechniquesindiagnostics
5. Introduction
toNGS(NextGenSequencing)forgeneticdisorders
Automationandanalysis
Subtopics:
1. Automation anditsadvantagesinsample preparation
2. Automationinbioanalysis
3. Advancedautomatedliquidhandlingsystems
4. RoboticWorkstations
5. HighthroughputScreening
Page
CapillaryElectrophoresis
Subtopics:
1. Introduction
2. Howcapillaryelectrophoresisworks
3. Whycapillaryelectrophoresisworks
4. CEhardware
5. Useinbio-analysis
6. Introduction toCE-MS
Page
ApplicationsofQuantitativeAnalysisforDrugs
Subtopics:
1. MSquantitationwithexample
2. Macromoleculequantitationwith example
ApplicationsofQualitativeAnalysis
Subtopics:
1. Techniqueofgeneratingdrugmetabolites
2. MetaboliteIdentification
3. Impurityprofiling(e.g.genotoxicimpurities,leachable,ex
tractable,etc.)
ResidueanalysisinFood
Subtopics:
1. Pesticides
2. Antibiotics
3. Residualsolvents
4. Mycotoxins
Tracer techniquesinBioanalyticalassays
Subtopics:
1. ConceptofRadioactivity&Halflife
2. ∝,β,γemittersandtheirbiologicalapplications
3. Using tracersinassays
4. Detectorsandcounters
5. Conceptofautoradiography
6. Radiolabelledprobesandtheiruses
7. Radiopharmaceuticals
8. Radiologicaldetectorforchromatography(radiometricde
tector)
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RegulatoryAspects ofASU drugs
Subtopics:
1. National initiativesforregulationofASUdrugs
2. ScheduleTandScheduleYofDrugsandCosmeticsAct
3. International
initiativesforregulationofASUdrugswithspecialreferenceto
a. WHOguidelinesontraditionalmedicine
b. ApproachesofUSandEUtoASUdrugregulation
4. ProvisionsofDrugsandCosmeticsActappliedtoASU(e.g.Sche
duleTandY)
EnvironmentalSafetyinBioanalyticallaboratory
Subtopics:
1. Strategiesto
reduceenvironmentalimpactofBioanalyticallaboratory
2. StandardsofLaboratorySafety(IncludingBiosafetyLevels)
3. OverviewofguidelinesforlaboratorieshandingRadioactivesub
stances
4. IntroductiontoISO14001andOSHAS 18001.
5. IntroductiontoEnvironmentImpactAssessment&Reporting
6. Biodiversity:RedDataBook,EndemicandendangeredMedicinal
Plant Species, Conservation and sustainable use ofmedicinal raw
materials, Introduction to Wildlife Act of India &CITES
7. CarbonfootprintsandCarboncredits.
ElectronicDataManagement
Subtopics:
1. ElectronicAcquisitionof data
2. ManagementofdatainComputers
3. ElectronicDataValidationandregulatoryrequirements
4. Electronicsignatures&its regulation
5. Generatingreportsusingcomputers
6. RegulatoryrequirementsofDataevaluation
7. LIMSandits applications
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RegulatoryIssues
Subtopics:
1. OTCdrugs
2. Cosmetics
3. Foodsupplements
4. Nutraceuticalsw.r.t.FSSIregulations
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Pharmacovigilance
Subtopics:
Introductionto:
1. Pharmacovigilance
2. Pharmacogenomics
3. Pharmacoeconomics
4. Pharmacometrics
Bioavailability–Bioequivalence(BA-BE)
Subtopics:
1. WhatisBAandBE?
2. DesignofaBAandBEstudy 3. ConductofaBAandBEstudy
4. FactorsthatinfluenceBA-BEofadrug
5. Estimating BA-BEparametersof adrug
6. Parametersto evaluateBA-BEofadrug
7. Datacollection,recordingand evaluation
8. ReportingaBA-BEstudy
9. RegulatoryrequirementsofBA-BE
10. EstimatingPharmacokineticparameters
11. AssessmentofBioequivalence
QCandQAofASUdrugs
Subtopics:
1. HerbalpharmacopoeiaandAyurvedic FormularyofIndia
2. ApproachestoQualitycontrolofASUformulations
3. Govtinitiatives
4. SomeInitiativesfrommanufacturers
5. QCofRMandIn-processmaterials (someexamples)
6. QC/OAforfinishedproducts (someexamples)
7. Applications of Herbal pharmacopoeia and
AyurvedicFormularyofIndia
8. RecentadvancesinQualitycontrolofASUformulations
9. QC / OA for finished products (some examples like Taila,
Vati,Churna,Sufoof, Jawarish,Majoon,etc.)
Therapeuticdrug monitoring
Subtopics:
1. PurposeoftherapeuticDrugMonitoring
2. Bioanalyticaltechniquesin TDM
3. AnalyticalandpracticalissuesofTDM
4. Pharmacoeconomicsof TDM
5. Regulatory aspectsofTDMwithcasestudies
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