Application and progress of physiologically-based oral absorption model in clinical development of generic drugs

Abstract

Abstract:

Demonstration of in vitro in vivo correlation (IVIVC) could identify key factors of pharmaceutical characteristics affecting drug efficacy, quality, stability, and safety. Compared with compartmental model-based deconvolution method, physiologically-based oral absorption model could better establish IVIVC by separating kinetics of permeability, metabolism, and transportation. Currently, physiologically-based oral absorption model has been extensively employed by big pharmaceutical companies in US and Europe to develop new formulation and support clinical bioequivalence (BE) trials. It is one of the major tools to simplify development of generic drugs and to evaluate the quality of generic drug application utilized by Food and Drug Administrator (FDA) in US. Regarding the regulatory need of Abbrevitive New Drug Application (ANDA) and generic drug consistency evaluation in China, we reviewed the application progress, investigation strategy, challenges, and regulatory utility of physiologically-based oral absorption model to support generic drug development in China.

Key words: physiologically-based oral absorption model, generic drugs

CLC Number:

R969.1

LILi, YANG Jinbo. Application and progress of physiologically-based oral absorption model in clinical development of generic drugs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(9): 961-965.

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