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TRANSCRIPT
APPLICATIONS FOR SENSORY SCIENCE TO
PHARMACEUTICAL AND NUTRACEUTICAL PRODUCTS
25 May 2005
Anne GoldmanDirector of Consumer Guidance Research
ACCEMississauga Ontario Canada
May 20052
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SUMMARY
• BACKGROUND• HISTORY• COMPLIANCE• SAFETY CONSIDERATIONS• SENSORY METHODS• IRB• PROTOCOL DEVELOPMENT• CASE STUDIES• OPPORTUNITIES GOING FORWARD
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BACKGROUND
• PHARMACEUTICALS– DEATH PREVENTION
• NUTRACEUTICALS– HEALTH RETENTION
GROWTH - Aging Demographics, Attention to Health
May 20054
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HISTORY
• THE FOOD INDUSTRY HAS A LONG HISTORY WITH SENSORY ANALYSIS 1960s
• PHARMACEUTICAL INDUSTRY 1990s with some exceptions:
• McNeil – Splenda, Benecol• Glaxo Smith Kline - Lucozade• Novartis – Gerber Baby Foods• Pfizer – Halls, Listerine
• SENSORY ANALYSIS ASSOCIATED MAINLY WITH NON PRESCRIPTION DRUG PRODUCTS
• AND NUTRACEUTICAL PRODUCTS
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COMPLIANCE
• COMPLIANCE IS COMPROMISED IF SENSORY PROPERTIES ARE UNACCEPTABLE
• BITTER ACTIVE INGREDIENT – TASTE COMPROMISED• UNPALATABLE TEXTURE (grittiness, tablet size and
shape) – SWALLOWING COMPROMISED
• A HEALTH OR THERAPEUTIC BENEFIT WILL NOT NECESSARILY COMPENSATE FOR AN UNACCEPTABLE SENSORY EXPERIENCE
May 20056
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CLINICAL TRIALS
• TO SUBSTANTIATE SAFETY & EFFECTIVENESS
• THREE PHASES– Phase I – preclinical – safety – optimal dosage– Phase II – large scale patient trial - effectiveness– Phase III – proceeds after passing Phases I and
II – testing against placebo• Proceeds to regulatory approval• Gather sensory/consumer data for marketing
purposes
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GOOD CLINICAL PRACTICE (GCP)
• INTERNATIONAL ETHICAL AND QUALITY STANDARD– DESIGNING, CONDUCTING, RECORDING &
REPORTING TRIALS INVOLVING HUMANS– COMPLIANCE PROVIDES ASSURANCE THAT
THE RIGHTS,SAFETY & WELL BEING OF SUBJECTS ARE PROTECTED
– STUDY DATA ARE CREDIBLE
May 20058
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SENSORY SCIENCE AND THE DEVELOPMENT CYCLE
Product Idea
Marketing Plan
Research & Clinical
Development Production Sales Distribution Post-Launch
Sensory Science
Maturity & Decline
GrowthInfancy - - - - - - - - - - - - - - - - - - - - -
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SENSORY METHODS
• DESCRIPTIVE SENSORY– Characterise the sensory profile– Highlight attributes of concern– Benchmark against controls– Discrimination
• CONSUMER STUDIES– Degree of like/dislike– Acceptable sensory dimensions– Likelihood for compliance– Market potential
May 200510
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INSTITUTIONAL REVIEW BOARD (IRB)
• PRIMARY PURPOSE– To protect human subjects from improperly
designed research• SECONDARY PURPOSE
– Evaluate the risk to benefit ratio• 5 or MORE MEMBERS
– At least one with a scientific and one with a non-scientific background, no conflict of interest
• REVIEWS– STUDY PROTOCOL, SAFETY SUMMARY,
FORMUALTIONS, INFORMED CONSENT, INVESTIGATOR CREDENTIALS
May 200511
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PROTOCOL DEVELOPMENT
• INTRODUCTION – study background, safety information and rationale
• OBJECTIVE – use of the results• STUDY DESIGN – experimental design• STUDY POPULATION – inclusion & exclusion criteria• STUDY MATERIALS – product description, handling• STUDY PROCEDURES – screening,informed consent,
number of study visits, evaluation method, withdrawal• ADVERSE EVENTS – procedures, 24 hour contact• ETHICAL ASPECTS – investigator, nurse, IRB,
informed consent• ADMINISTRATIVE – record retention, use of study
May 200512
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THE INFORMED CONSENT DOCUMENT
• STATEMENT OF RESEARCH• REASONABLY FORESEEABLE RISKS• BENEFITS TO SUBJECTS• CONFIDENTIALITY OF RECORDS• COMPENSATION & TREATMENT FOR INJURY• VOLUNTARY PARTICIPATION STATEMENT• RISKS THAT ARE UNFORESEEABLE• CIRCUMSTANCES FOR TERMINATION• WITHDRAWAL & TERMINATION• NEW FINDINGS & FURTHER STUDY• APPROXIMATE NUMBER OF SUBJECTS
May 200513
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CASE STUDY – CHILD’S FEVER MEDICATION
• PARENTAL & CHILD CONSENT• CATEGORY & BRAND USERS• SUBJECTS IN GOOD HEALTH• NO HISTORY OF ALLERGIC REACTION TO ANY
INGREDIENT IN THE TEST PRODUCTS• NO MEDICATION AT THE TIME OR 48 HOURS
PRECEDING THE STUDY• TEST AMOUNT
– TOTAL = LESS THAN ONE DAILY DOSAGE FOR YOUNGEST CHILD IN THE STUDY
May 200514
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CASE STUDY – CHILD’S FEVER MEDICATION
• Interviewing the study subjects
May 200515
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CASE STUDY – CHILD’S FEVER MEDICATION
DATA COLLECTION – CHILD FRIENDLY SCALES
• OPINION OF TASTE• TAKE WHEN YOU ARE SICK?• INTERVIEWER OBSERVATIONS AS CHILD TASTES• AS WELL AS:
– COLOUR– SMELL– SWEETNESS– FLAVOUR IDENTITY/DESCRIPTION
May 200516
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CASE STUDY – CHILD’S FEVER MEDICATION
• Children like more intense blue/red colours than pale yellow or no colour
6.2
6.1
6.0
5.8
5.6
5.3
4.7
4.3
Purple
Cherry/Red
Red
Green
Pale Purple
Pale orange
Pale yellow
No colour
Opinion of liking of colour - fever medicationAverage mean scores, 1=dislike a whole lot 7 = like a whole lot
May 200517
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PRODUCT CLAIM - CHILDREN’S FEVER TABLETS
Now Children's Tylenol™ comes in a new form that kids love! New Children's Tylenol™ Meltaways. Fast relief that melts in your child's mouth—in yummy Grape Punch, Wacky Watermelon, and Bubblegum Burst. Meltaways are easy to give—no spoon and no water needed. And easy to take. Kids prefer it.
.
May 200518
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FLAVOURHealth Benefits
Convenience
Quality
CASE STUDY – STANOL MARGARINE
May 200519
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CASE STUDY – STANOL MARGARINE
• CATEGORY & BRAND USERS• Have concerns about their cholesterol and manage
their cholesterol intake by diet not medication• SUBJECTS IN GOOD HEALTH• NO HISTORY of or active gastro intestinal disease or
have had an intestinal surgery• NO MEDICATION OR SUPPLEMENTS AT THE TIME
OR 48 HOURS PRECEDING THE STUDY• WILLING TO SIGN AN INFORMED CONSENT
May 200520
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CASE STUDY – STANOL MARGARINE
• PROTOTYPE & SHELF LIFE TESTING– Test prototypes containing stanol ingredient against
control margarine– Descriptive sensory panel
• CONSUMER TESTING– CLT Prototype v Control for acceptance on bread– HUT prior to market introduction
May 200521
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OPPORTUNITIES GOING FORWARD
• AREA OF GROWTH - increased consumer involvement with health maintenance as population ages
• PHARMACEUTICALS - recognition of sensory issues in the early stages of clinical development to improve product compliance issues
• NUTRACEUTICALS – optimise sensory properties for consumer acceptance. Health benefits will not be enough to ensure market success
• FUTURE RESEARCH - better understanding of masking agents and bitterness blockers – taste receptor research,as well as disease effects on sensory perception