Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Author:

Pepin Xavier1ORCID,Arora Sumit2ORCID,Borges Luiza3,Cano-Vega Mario4,Carducci Tessa5,Chatterjee Parnali6,Chen Grace7,Cristofoletti Rodrigo8,Dallmann André9ORCID,Delvadia Poonam10ORCID,Dressman Jennifer11,Fotaki Nikoletta12,Gray Elizabeth6,Heimbach Tycho13,Holte Øyvind14,Kijima Shinichi15,Kotzagiorgis Evangelos16,Lennernäs Hans17,Lindahl Anders18,Loebenberg Raimar19,Mackie Claire2ORCID,Malamatari Maria20ORCID,McAllister Mark21,Mitra Amitava22,Moody Rebecca6,Mudie Deanna23ORCID,Musuamba Tshinanu Flora24,Polli James E.25ORCID,Rege Bhagwant6,Ren Xiaojun26,Rullo Gregory27,Scherholz Megerle28,Song Ivy7,Stillhart Cordula29,Suarez-Sharp Sandra1,Tannergren Christer30ORCID,Tsakalozou Eleftheria31,Veerasingham Shereeni32,Wagner Christian33,Seo Paul10

Affiliation:

1. Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States

2. Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium

3. ANVISA, SIA Trecho 5́, Guara, Brasília, Federal District 71205-050, Brazil

4. Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320-1799, United States

5. Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, New Jersey 07065, United States

6. Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States

7. Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States

8. College of Pharmacy, University of Florida, 6550 Sanger Rd., Orlando, Florida 32827, United States

9. Bayer HealthCare SAS, 59000 Lille, France, on behalf of Bayer AG, Pharmacometrics/Modeling and Simulation, Systems Pharmacology & Medicine, PBPK, Leverkusen, Germany

10. Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States

11. Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt am Main 60596, Germany

12. University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom

13. Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States

14. Norwegian Medical Products Agency, Oslo 0213, Norway

15. Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan

16. European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands

17. Translational Drug Discovery and Development, Department of Pharmaceutical Bioscience, Uppsala University, Uppsala 751 05, Sweden

18. Swedish Medical Products Agency, Uppsala 752 37, Sweden

19. Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmontonton T6G 2E1, Canada

20. Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, United Kingdom

21. Global Biopharmaceutics, Drug Product Design, Pfizer, Sandwich CT13 9NJ, United Kingdom

22. Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States

23. Global Research and Development, Small Molecules, Lonza, 63045 NE Corporate Pl., Bend, Oregon 97701, United States

24. Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussel 1210, Belgium

25. School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States

26. PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States

27. Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States

28. Pharmaceutical Development, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, New Jersey 08543, United States

29. Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland

30. Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 50, Sweden

31. Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States

32. Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa K1A 0K9, Canada

33. Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt D-64293, Germany

Funder

Center for Drug Evaluation and Research

Publisher

American Chemical Society (ACS)

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