Individual bioequivalence—a regulatory update

DOI10.1080/10543409708835162zbMATH Open1063.62587OpenAlexW2023574125WikidataQ41369444 ScholiaQ41369444MaRDI QIDQ4239490FDOQ4239490

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

Recommendations

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

zbMATH Keywords

individual bioequialence

Mathematics Subject Classification ID

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

Cites Work

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

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.

This page was built for publication: Individual bioequivalence—a regulatory update

Report a bug (only for logged in users!)Click here to report a bug for this page (MaRDI item Q4239490)