Past,Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products |
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| Authors: | Rodrigo Cristofoletti Malcolm Rowland Lawrence J. Lesko Henning Blume Amin Rostami-Hodjegan Jennifer B. Dressman |
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| Affiliation: | 1. Brazilian Health Surveillance Agency (ANVISA), Division of Therapeutic Equivalence, Brasilia, Brazil;2. Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany;3. Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK;4. Center for Pharmacometrics and Systems Pharmacology, University of Florida, Orlando, Florida 32827;5. SocraTec C&S, Oberursel, Germany;6. Certara, 1 Concourse Way, Sheffield, UK |
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| 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. |
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| Keywords: | bioequivalence pharmacokinetics regulatory science dissolution mechanistic modeling pharmacokinetic/pharmacodynamic (PK/PD) correlation |
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