A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products

Journal of Clinical Pharmacology

Volumn 40, Issue 10, 2000, Pages 1102-1108

  Kimanani, E ^a   Stypinski, D ^a   Curtis, G ^a   Stiles, M ^a   Heessels, P ^a   Logan, S ^a   Nelson, K ^a   St Germain, E ^a   Boswell, G ^a  

^a MDS Inc   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG DESIGN; DRUG ELIMINATION; ETHICS; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; REVIEW; VALIDATION PROCESS;

ADMINISTRATION, ORAL; CONTRACT SERVICES; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION; DRUG INDUSTRY; HUMANS; PHARMACOKINETICS; RESEARCH DESIGN; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033668827     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (12)

1. Towards a practical strategy for assessing individual bioequivalence
2. Individual bioequivalence: Attractive in principle, difficult in practice
3. Aggregate versus disaggregate criterion
4. Individual bioequivalence: A review of the FDA guidance
5. A simple approach for the evaluation of individual bioequivalence
6. A parametric confidence interval for a moment-based scaled criterion for individual bioequivalence
7. Definition of individual bioequivalence: Occasion-to-occasion versus mean switchability
8. Numerical methods for the evaluation of individual bioequivalence
9. Power and sample size for bioequivalence studies