Individual bioequivalence—a regulatory update

DOI10.1080/10543409708835162MaRDI QIDQ4239490zbMATH OpenOpenAlexWikidataFDO

Authors Meiling Chen

Publication date 1997

Published in Journal of Biopharmaceutical Statistics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1080/10543409708835162

zbMATH Keywords

individual bioequialence

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• An alternative definition of individual bioequivalence
• Statistical evaluation of individual bioequivalence
• The assessment of individual and population bioequivalence
• On Testing of Individual Bioequivalence

Cites work

• Assessment of Individual and Population Bioequivalence Using the Probability That Bioavailabilities are Similar
• Extension to the use of tolerance intervals for the assessment of individual bioequivalence
• Moment-based criteria for determining bioequivalence
• The Subject-by-Formulation Interaction as a Criterion of Interchangeability of Drugs

Cited in

(5)

• Some issues for the consideration of individual bioequivalence
• Statistical evaluation of individual bioequivalence
• `Equivalence is different' -- some comments on therapeutic equivalence
• BIOEQUIVALENCE REVIEW FOR DRUG INTERCHANGEABILITY
• Bayesian construction of an improved parametric test for probability-based individual bioequiv\-a\-lence.

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