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Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2.

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

Author information

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.

Abstract

This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members. Examples of regulatory submission of PBPK analyses across various intended applications are presented and discussed. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recent draft guidelines regarding PBPK analyses and reporting are encouraging, and to advance the use and acceptability of PBPK analyses, more clarity and flexibility are warranted.

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