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

Author:

Walenga Ross L.1,Butler Clare2,Craven Brent A.3ORCID,Longest P. Worth4,Mohamed Raja5,Newman Bryan6,Olsson Bo7,Hochhaus Günther8ORCID,Li Bing V.9,Luke Markham C.6,Zhao Liang1,Przekwas Andrzej10,Lionberger Robert11

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference71 articles.

1. Inhaled medicines: past, present, and future;Anderson S;Pharmacol Rev,2022

2. Pulmonary cytochrome P‐450 monooxygenase system and Clara cell differentiation in rats;Ji CM;Am J Physiol Lung Cell Mol Physiol,1995

3. Immunological identification and effects of 3‐methylcholanthrene and phenobarbital on rat pulmonary cytochrome P‐450;Keith IM;Cancer Res,1987

4. Mechanisms of macromolecule absorption by the lungs;Patton JS;Adv Drug Deliv Rev,1996

5. Inhaling medicines: delivering drugs to the body through the lungs;Patton JS;Nat Rev Drug Discov,2007

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