Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

Ross L Walenga; Clare Butler; Brent A Craven; P Worth Longest; Raja Mohamed; Bryan Newman; Bo Olsson; Günther Hochhaus; Bing V Li; Markham C Luke; Liang Zhao; Andrzej Przekwas; Robert Lionberger

doi:10.1002/psp4.12889

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT Pharmacometrics Syst Pharmacol. 2023 May;12(5):560-574. doi: 10.1002/psp4.12889. Epub 2022 Dec 20.

Authors

Ross L Walenga¹, Clare Butler², Brent A Craven³, P Worth Longest⁴, Raja Mohamed⁵, Bryan Newman⁶, Bo Olsson⁷, Günther Hochhaus⁸, Bing V Li⁹, Markham C Luke⁶, Liang Zhao¹, Andrzej Przekwas¹⁰, Robert Lionberger¹¹

Affiliations

¹ Division of Quantitative Methods and Modeling, 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 Inhaled Drug Product Research and Development Division, Teva Pharmaceuticals Ireland, Waterford, Ireland.
³ Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Virginia Commonwealth University, Richmond, Virginia, USA.
⁵ Novartis Healthcare Private Ltd, Sandoz Development Centre (SDC), India.
⁶ Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
⁷ Emmace Consulting AB, Lund, Sweden.
⁸ Department of Pharmaceutics, University of Florida, Gainesville, Florida, USA.
⁹ Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
¹⁰ CFD Research Corporation, Huntsville, Alabama, USA.
¹¹ Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Abstract

In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States. This review summarizes the presentations and panel discussion that comprised a workshop session concentrated on the use of in silico models to predict various outcomes following orally inhaled drug product administration, including the status of such models and how model credibility may be effectively established.

© 2022 Teva Pharmaceuticals Ireland, Novartis Healthcare Private Limited, India and The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.

Publication types

Review

MeSH terms

Administration, Inhalation
Computer Simulation
Drugs, Generic*
Humans
Research Report*
Therapeutic Equivalency

Substances

Drugs, Generic