ICH M9 Guideline in Development on Biopharmaceutics Classification System-Based Biowaivers: An Industrial Perspective from the IQ Consortium

Author:

Bransford Philip1,Cook Jack2ORCID,Gupta Manish3,Haertter Sebastian4,He Handan5,Ju Rob6,Kanodia Jitendra7,Lennernäs Hans8ORCID,Lindley David9,Polli James E.10ORCID,Wenning Larissa11,Wu Yunhui12

Affiliation:

1. Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, Massachusetts 02210, United States

2. Clinical Pharmacology Department, Global Product Development, Pfizer, Inc., Groton, Connecticut 06320, United States

3. Biopharmaceutics, Product Development and Supply, GlaxoSmithKline, Collegeville, Pennsylvania 19426, United States

4. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut 06877, United States

5. Department of Drug Metabolism and Pharmacokinetics, Novartis Institutes for Biomedical Research, East Hanover, New Jersey 07936, United States

6. Drug Product Development, Abbvie, North Chicago, Illinois 60064, United States

7. Theravance Biopharma US, Inc., South San Francisco, California 94080, United States

8. Department of Pharmacy, Uppsala University, Box 580, 751 23 Uppsala, Sweden

9. AbbVie Inc., North Chicago, Illinois 60064, United States

10. Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201, United States

11. Pharmacokinetics, Pharmacodynamics and Drug Metabolism, MRL, Merck & Co., Inc., West Point, Pennsylvania 19486, United States

12. Pharmaceutical Sciences, MRL, Merck & Co., Inc., West Point, Pennsylvania 19486, United States

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

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