Please use this identifier to cite or link to this item: https://doi.org/10.4172/jbb.1000182
Title: In vivo and in vitro bioequivalence testing
Authors: Lu, Y
Chow, S.-C 
Zhu, S
Keywords: area under the curve
article
bioequivalence
bootstrapping
clinical assessment
drug absorption
geometry
maximum plasma concentration
particle size
pharmacodynamics
prescription
Issue Date: 2014
Publisher: OMICS Publishing Group
Citation: Lu, Y, Chow, S.-C, Zhu, S (2014). In vivo and in vitro bioequivalence testing. Journal of Bioequivalence and Bioavailability 6 (2) : 67-74. ScholarBank@NUS Repository. https://doi.org/10.4172/jbb.1000182
Rights: Attribution 4.0 International
Abstract: For approval of generic drug products, the FDA requires that evidence of average bioequivalence in drug absorption be provided through the conduct of bioequivalence studies. As indicated in 21CFR320.24, bioequivalence may be established by in vivo (e.g., pharmacokinetic, pharmacodynamic, or clinical) and in vitro studies or with suitable justification by in vitro studies alone. In this presentation, an overview of statistical considerations including study design, criteria, and statistical methods for assessment of bioequivalence will be provided. For in vivo bioequivalence testing, in addition to average bioequivalence, the concept of population bioequivalence and individual bioequivalence for addressing drug interchangeability will also be discussed. For in vitro bioequivalence testing, an overview regarding some in vitro tests such as dose or spray content uniformity through container's life, droplet and drug particle size distribution, spray pattern, plume geometry, priming and repriming, and tail off profile that are commonly employed for local action drug products such as nasal aerosols and nasal sprays products will be provided. Recent development and future research topics will also be discussed. © 2014 Lu Y, et al.
Source Title: Journal of Bioequivalence and Bioavailability
URI: https://scholarbank.nus.edu.sg/handle/10635/180762
ISSN: 0975-0851
DOI: 10.4172/jbb.1000182
Rights: Attribution 4.0 International
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