Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Lanyan Fang; Myong-Jin Kim; Zhichuan Li; Yaning Wang; Charles E DiLiberti; Jessie Au; Andrew Hooker; Murray P Ducharme; Robert Lionberger; Liang Zhao

doi:10.1002/cpt.1065

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Clin Pharmacol Ther. 2018 Jul;104(1):27-30. doi: 10.1002/cpt.1065. Epub 2018 Mar 30.

Authors

Affiliations

¹ Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Montclair Bioequivalence Services, LLC, Montclair, New Jersey, USA.
⁴ Optimum Therapeutics LLC, Carlsbad, California, USA.
⁵ Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
⁶ Learn and Confirm Inc., Bois Franc, St-Laurent, Canada.

PMID: 29603191
DOI: 10.1002/cpt.1065

Abstract

On October 2^nd and 3^rd , 2017, the US Food and Drug Administration (FDA) hosted a public workshop titled "Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review."¹ This report summarizes Session 2 of the public workshop: "Model Informed Drug Development and Review for Generic Products." The session focused on the application of quantitative methods and modeling in modernizing the generic drug development and review.

Publication types

Research Support, U.S. Gov't, P.H.S.

MeSH terms

Drug Approval*
Drug Development*
Drugs, Generic*
Education
Humans
Therapeutic Equivalency
United States
United States Food and Drug Administration*

Substances

Drugs, Generic