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

Rodrigo Cristofoletti, Malcolm Rowland, Lawrence J. Lesko, Henning Blume, Amin Rostami-hodjegan, Jennifer B. Dressman

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
Pages (from-to)2519-2530
Number of pages11
JournalJournal of Pharmaceutical Sciences
Volume107
Issue number10
Early online date20 Jun 2018
DOIs
Publication statusPublished - Oct 2018

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