An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction

J Clin Pharmacol. 2019 Sep;59(9):1245-1248. doi: 10.1002/jcph.901. Epub 2019 May 14.

Authors

Lawrence J Lesko¹, Lanyan Fang², Stephan Schmidt¹, Mirjam N Trame¹

Affiliations

¹ Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
² Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Food and Drug Administration, Silver Spring, MD, USA.

PMID: 31087551
DOI: 10.1002/jcph.901

No abstract available

Keywords: Biopharmaceutics (BPC); Clinical Pharmacology (CPH); PBPK; Pharmacometrics; Regulatory/Scientific Affairs (REG).

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Biopharmaceutics / methods
Chemistry, Pharmaceutical
Computational Biology / methods
Drugs, Generic / adverse effects*
Drugs, Generic / therapeutic use*
Humans
Models, Biological
United States
United States Food and Drug Administration

Substances

Drugs, Generic

Grants and funding

U01 FD005210/FD/FDA HHS/United States