Individual bioequivalence—a european perspective

DOI10.1080/10543409708835166zbMath0925.62482OpenAlexW1993337380WikidataQ41369480 ScholiaQ41369480MaRDI QIDQ4239494

Volker W. Steinijans, Dieter Hauschke

Publication date: 20 June 1999

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

Full work available at URL: https://doi.org/10.1080/10543409708835166

zbMATH Keywords

average bioequivalenceindividual bioequivalencepopulation bioequivalencesubject-by-formulation interactionequivalence acceptance limitshighly variable drugsreplicate designsscaled criteria

Mathematics Subject Classification ID

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

Cites Work

• Exact Inference About the Within-Subject Variability in 2 × 2 Crossover Trials
• 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