Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective-Reference-Cited by-同舟云学术

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

Published:2018-02-02 Issue:1 Volume:104 Page:88-110
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Shebley Mohamad¹,Sandhu Punam²,Emami Riedmaier Arian¹,Jamei Masoud³,Narayanan Rangaraj⁴,Patel Aarti⁵,Peters Sheila Annie⁶,Reddy Venkatesh Pilla⁷,Zheng Ming⁸,de Zwart Loeckie⁹,Beneton Maud¹⁰,Bouzom Francois¹¹,Chen Jun¹²,Chen Yuan¹³,Cleary Yumi¹⁴,Collins Christiane¹⁵,Dickinson Gemma L.¹⁶,Djebli Nassim¹²,Einolf Heidi J.¹⁷,Gardner Iain³,Huth Felix¹⁸,Kazmi Faraz⁹,Khalil Feras¹⁹,Lin Jing²⁰,Odinecs Aleksandrs²¹,Patel Chirag²²,Rong Haojing⁴,Schuck Edgar²³,Sharma Pradeep⁷,Wu Shu-Pei²⁴,Xu Yang²⁵,Yamazaki Shinji²⁶,Yoshida Kenta¹³,Rowland Malcolm²⁷

Affiliation:

1. AbbVie Inc.; North Chicago Illinois USA

2. Merck & Co.; Kenilworth New Jersey USA

3. Simcyp (a Certara Company); Sheffield UK

4. Shire; Lexington MA USA

5. GlaxoSmithKline; Ware UK

6. Merck KGaA; Darmstadt Germany

7. AstraZeneca; Cambridge UK

8. Bristol-Myers Squibb; Princeton NJ USA

9. Johnson & Johnson; Beerse Belgium

10. Servier; Centre-Val de Loire France

11. UCB Biopharma; Braine I'Alleud Belgium

12. Sanofi; Région de Montpellier France

13. Genentech; San Francisco CA USA

14. Roche Innovation Center; Basel Switzerland

15. Astellas; Leiden The Netherlands

16. Eli Lilly & Company; Indianapolis Indiana USA

17. Novartis; East Hanover NJ USA

18. Novartis; Basel Switzerland

19. Grünenthal; Aachen Germany

20. Sunovion Pharmaceuticals Inc.; Marlborough MA USA

21. Nektar Therapeutics; San Francisco CA USA

22. Takeda Pharmaceuticals International Co.; Cambridge MA USA

23. Eisai Inc.; Woodliff Lake NJ USA

24. Vertex Pharmaceuticals; Boston MA USA

25. Amgen; CA USA

26. Pfizer; San Diego CA USA

27. University of Manchester; UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference69 articles.

1. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective;Jones;Clin. Pharmacol. Ther.,2015

2. Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK;Wagner;CPT Pharmacometrics Syst. Pharmacol.,2015

3. Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency;Luzon;Clin. Pharmacol. Ther.,2016

4. Quantitative modeling and simulation in PMDA: a Japanese regulatory perspective;Sato;CPT Pharmacometrics Syst. Pharmacol.,2017

5. United States Food and Drug Administration. Guidance for Industry: physiologically Based Pharmacokinetic Analyses-Format and Content https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM531207.pdf

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