Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective-Reference-Cited by-同舟云学术

Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective

Published:2020-12-30 Issue:2 Volume:110 Page:297-310
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Heimbach Tycho¹,Chen Yuan²,Chen Jun³,Dixit Vaishali⁴,Parrott Neil⁵,Peters Sheila Annie⁶,Poggesi Italo⁷,Sharma Pradeep⁸,Snoeys Jan⁹,Shebley Mohamad¹⁰,Tai Guoying¹¹,Tse Susanna¹²,Upreti Vijay V.¹³,Wang Ying‐Hong¹⁴,Tsai Alice¹⁵,Xia Binfeng¹⁶,Zheng Ming¹⁷,Zhu Andy Z.X.¹⁸,Hall Stephen¹⁹

Affiliation:

1. Pharmaceutical Sciences Merck & Co., Inc Rahway New Jersey USA

2. Department of Drug Metabolism and Pharmacokinetics Genentech, Inc South San Francisco California USA

3. Clinical Pharmacology Alkermes Inc Waltham Massachusetts USA

4. Drug Metabolism and Pharmacokinetics Kymera Therapeutics Watertown Massachusetts USA

5. Pharmaceutical Sciences Roche Innovation Center Basel, F. Hoffmann‐La Roche Ltd Basel Switzerland

6. Translational Medicine Merck Healthcare KGaA Darmstadt Germany

7. Clinical Pharmacology and Pharmacometrics Janssen Milan Italy

8. Clinical Pharmacology & Quantitative Pharmacology Clinical Pharmacology & Safety Sciences R&D, AstraZeneca Cambridge UK

9. Department of Drug Metabolism and Pharmacokinetics Janssen R&D Beerse Belgium

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

11. Department of Drug Metabolism and Pharmacokinetics GlaxoSmithKline Plc Collegeville Pennsylvania USA

12. Department of Pharmacokinetics, Dynamics and Metabolism Pfizer Inc Groton Connecticut USA

13. Clinical Pharmacology Modeling & Simulation Amgen Inc South San Francisco California USA

14. Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism Merck & Co, Inc Kenilworth New Jersey USA

15. Department of Drug Metabolism and Pharmacokinetics Vertex Pharmaceuticals Inc Boston Massachusetts USA

16. PK/PD Group Pharmacokinetics, Dynamics and Metabolism Sanofi, Bridgewater New Jersey USA

17. Clinical Pharmacology and Pharmacometrics Bristol‐Myers Squibb Princeton New Jersey USA

18. Drug Metabolism and Pharmacokinetics Takeda Pharmaceuticals International, Co Cambridge Massachusetts USA

19. Department of Drug Disposition Lilly, Indianapolis Indiana USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2125

Reference37 articles.

1. The successes and failures of physiologically based pharmacokinetic modeling: there is room for improvement

2. Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

3. Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

4. Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

5. Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

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