Some statistical considerations on the FDA draft guidance for individual bioequivalence

Statistics in Medicine

Volumn 19, Issue 20, 2000, Pages 2879-2884

  Hsuan, Francis C ^a  

^a TEMPLE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; DRUG BIOAVAILABILITY; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; STANDARD; STATISTICAL ANALYSIS;

AREA UNDER CURVE; GUIDELINES; HUMAN; MODELS, STATISTICAL; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034735557     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001030)19:20<2879::AID-SIM552>3.0.CO;2-9     Document Type: Article

References (22)

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8. Bioequivalence revisited
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11. Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence
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14. Conference report of bio-international 92 on bioavailability, bioequivalence and pharmacokinetic studies
15. Discussion of individual bioequivalence by M. L. Chen
16. Individual bioequivalence: Attractive in principle, difficult in practice
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19. Commentary on individual bioequivalence by M. L. Chen
20. A comment on so-called individual criteria of bioequivalence
21. Statistical simulation study of new proposed uniformity requirement for bioequivalence studies
22. Some thoughts on individual bioequivalence