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J Pharm Sci. 2018 Oct;107(10):2519-2530. doi: 10.1016/j.xphs.2018.06.013. Epub 2018 Jun 20.

Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products.

Author information

1
Brazilian Health Surveillance Agency (ANVISA), Division of Therapeutic Equivalence, Brasilia, Brazil; Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.
2
Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK.
3
Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida 32827.
4
SocraTec C&S, Oberursel, Germany.
5
Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK; Certara, 1 Concourse Way, Sheffield, UK.
6
Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address: dressman@em.uni-frankfurt.de.

Abstract

The growth in the utilization of systems thinking principles has created a paradigm shift in the regulatory sciences and drug product development. Instead of relying extensively on end product testing and one-size-fits-all regulatory criteria, this new paradigm has focused on building quality into the product by design and fostering the development of product-specific, clinically relevant specifications. In this context, this commentary describes the evolution of bioequivalence regulations up to the current day and discusses the potential of applying a Bayesian-like approach, considering all relevant prior knowledge, to guide regulatory bioequivalence decisions in a patient-centric environment.

KEYWORDS:

bioequivalence; dissolution; mechanistic modeling; pharmacokinetic/pharmacodynamic (PK/PD) correlation; pharmacokinetics; regulatory science

PMID:
29935299
DOI:
10.1016/j.xphs.2018.06.013

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