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

Autor: Walenga RL; 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., Butler C; Inhaled Drug Product Research and Development Division, Teva Pharmaceuticals Ireland, Waterford, Ireland., Craven BA; 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., Longest PW; Virginia Commonwealth University, Richmond, Virginia, USA., Mohamed R; Novartis Healthcare Private Ltd, Sandoz Development Centre (SDC), India., Newman B; 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., Olsson B; Emmace Consulting AB, Lund, Sweden., Hochhaus G; Department of Pharmaceutics, University of Florida, Gainesville, Florida, USA., Li BV; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Luke MC; 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., Zhao L; 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., Przekwas A; CFD Research Corporation, Huntsville, Alabama, USA., Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Jazyk: angličtina
Zdroj: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 560-574. Date of Electronic Publication: 2022 Dec 20.
DOI: 10.1002/psp4.12889
Abstrakt: 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.)
Databáze: MEDLINE
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