Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program-Reference-Cited by-同舟云学术

Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program

Published:2021-05-15 Issue:5 Volume:110 Page:1172-1175
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharmacol Ther

Author:

Galluppi Gerald R.¹,Brar Satjit²,Caro Luzelena³,Chen Yuan⁴,Frey Nicolas⁵,Grimm Hans Peter⁵,Rudd Deanne Jackson³,Li Chi‐Chung⁶,Magee Mindy⁷,Mukherjee Arnab²,Nagao Lee⁸,Purohit Vivek S.²,Roy Amit⁹,Salem Ahmed Hamed¹⁰¹¹,Sinha Vikram³,Suleiman Ahmed A.¹²,Taskar Kunal S.¹³,Upreti Vijay V.¹⁴,Weber Benjamin¹⁵,Cook Jack²

Affiliation:

1. Sunovion Pharmaceuticals, Inc. Marlborough Massachusetts USA

2. Clinical Pharmacology Global Product Development Pfizer Inc. Groton Connecticut USA

3. Quantitative Pharmacology and Pharmacometrics Pharmacokinetics, Pharmacodynamics and Drug Metabolism Merck Research LaboratoriesMerck & Co., Inc. Kenilworth New Jersey USA

4. Department of Drug Metabolism and Pharmacokinetics Genentech Inc., a member of the Roche Group South San Francisco California USA

5. Roche Pharma Research and Exploratory Development Pharmaceutical Science Roche Innovation Center Basel Switzerland

6. Department of Clinical Pharmacology Genentech, member of the Roche group South San Francisco California USA

7. GlaxoSmithKline Philadelphia Pennsylvania USA

8. Faegre Drinker Biddle & Reath, LLP Washington DC USA

9. Bristol Myers, Inc. Woodbury Connecticut USA

10. Clinical Pharmacology and Pharmacometrics AbbVie Inc. North Chicago Illinois USA

11. Ain Shams University Cairo Egypt

12. Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein Germany

13. DMPK, IVIVTGlaxoSmithKline Ware UK

14. Clinical Pharmacology Modeling and Simulation Amgen Inc. South San Francisco California USA

15. Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield Connecticut USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2265

Reference5 articles.

1. Model-Based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

2. U.S. Food and Drug Administration.Model‐Informed Drug Development Pilot Program (2/9/2021). Accessed March 26 2021.

3. The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact

4. Madabushi R.Mainstreaming MIDD: A Holistic and Integrative Approach. Rosa Webinar Series. February 2020 . Accessed March 26 2021.

5. Model-Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives

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