Population and individual bioequivalence: Lessons from real data and simulation studies

Journal of Clinical Pharmacology

Volumn 41, Issue 8, 2001, Pages 811-822

  Zariffa, N M D ^a   Patterson, S D ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED DRUG RELEASE; DATA BASE; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; STATISTICAL ANALYSIS;

DATA COLLECTION; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034921142     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/00912700122010708     Document Type: Article

References (16)

1. The subject-by-formulation interaction as a criterion for interchangeability of drugs
2. Subject-by-formulation interaction in determinations of individual bioequivalence
3. A small sample confidence interval approach to assess individual bioequivalence
4. PhRMA perspective on population and individual bioequivalence
5. Case studies, practical issues and observations on population and individual bioequivalence
6. Bioavailability and bioequivalence: Average, population, and/or individual
7. Types of bioequivalence and related statistical considerations
8. Subject-by-formulation interaction in bioequivalence: Conceptual and statistical issues
9. Bioequivalence of methylphenidate immediate-release tablets using a replicated study design to characterize intrasubject variability
10. A practical approach for evaluating population and individual bioequivalence
11. Kullback-Leibler distance for evaluating bioequivalence: I. Criteria and methods