Evaluation of partial area under the curve in bioequivalence studies using destructive sampling design

• Published in: Journal of veterinary pharmacology and therapeutics Vol. 44; no. 4; pp. 628 - 643
• Main Authors: Martinez, Marilyn N., Gao, Shasha
• Format: Journal Article
• Language: English
• Published: England 01.07.2021
• Subjects: absorption; Bailer–Satterthwaite–Fieller; bioequivalence; blood; blood sampling; blood volume; confidence interval; destructive samples; fish; partial AUC; pharmacokinetics; therapeutics; partial AUC; confidence interval; Bailer-Satterthwaite-Fieller; bioequivalence; destructive samples

Product blood‐level in vivo bioequivalence (BE) studies typically involve complete blood concentration–time profiles generated for each subject. Accordingly, each subject provides the estimates of the rate and extent of drug absorption. However, repeated blood draws are not always feasible for studi...