Current Practices, Gap Analysis, and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective-Reference-Cited by-同舟云学术

Current Practices, Gap Analysis, and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective

Published:2021-12-24 Issue: Volume: Page:
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Hariparsad Niresh¹,Ramsden Diane²,Taskar Kunal³,Badée Justine⁴,Venkatakrishnan Karthik⁵⁶,Reddy Micaela B.⁷,Cabalu Tamara⁸,Mukherjee Dwaipayan⁹,Rehmel Jessica¹⁰,Bolleddula Jayaprakasam⁵⁶,Emami Riedmaier Arian¹¹,Prakash Chandra¹²,Chanteux Hugues¹³,Mao Jialin¹⁴,Umehara Kenichi¹⁵,Shah Kushal¹⁶,De Zwart Loeckie¹⁷,Dowty Martin¹⁸,Kotsuma Masakatsu¹⁹,Li Mengyao²⁰,Pilla Reddy Venkatesh²¹,McGinnity Dermot F.²²,Parrott Neil¹⁵

Affiliation:

1. DMPK, Research and Early Development Oncology R&D AstraZeneca Boston Massachusetts USA

2. Takeda Development Center Americas, Inc. Cambridge Massachusetts USA

3. Drug Metabolism and Pharmacokinetics IVIVTGlaxoSmithKline Stevenage UK

4. PK Sciences Novartis Institutes for Biomedical Research Basel Switzerland

5. EMD Serono Research & Development Institute, Inc Billerica Massachusetts USA

6. Merck KGaA Darmstadt Germany

7. Department of Clinical Pharmacology, Oncology Pfizer Boulder Colorado USA

8. Merck & Co., Inc. Kenilworth New Jersey USA

9. Clinical Pharmacology & Pharmacometrics AbbVie, Inc. North Chicago Illinois USA

10. Lilly Research Laboratories Eli Lilly and Company Indianapolis Indiana USA

11. Bristol Meyers Squibb Princeton New Jersey USA

12. Agios Pharmaceuticals Cambridge Massachusetts USA

13. UCB BiopharmaQP‐DMPK Brussels Belgium

14. Department of Drug Metabolism and Pharmacokinetics GenentechA Member of the Roche Group South San Francisco California USA

15. Pharmaceutical Sciences Roche Pharma Research & Early Development Roche Innovation Center Basel Basel Switzerland

16. Drug Metabolism and Pharmacokinetics Vertex Pharmaceuticals Incorporated Boston Massachusetts USA

17. DMPK Janssen Research and Development Beerse Belgium

18. Department of Pharmacokinetics, Dynamic, and Metabolism Pfizer Cambridge Massachusetts USA

19. Quantitative Clinical Pharmacology Daiichi‐Sankyo, Inc. New Jersey USA

20. Pharmacokinetics, Dynamics and Metabolism Sanofi Bridgewater New Jersey USA

21. Clinical Pharmacology and Pharmacometrics Biopharmaceuticals R&D AstraZeneca Cambridge UK

22. DMPK, Research and Early Development Oncology R&D AstraZeneca Cambridge UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2503

Reference45 articles.

1. Drugs Behave as Substrates, Inhibitors and Inducers of Human Cytochrome P450 3A4

2. Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance

3. The Induction of Cytochrome P450 3A5 (CYP3A5) in the Human Liver and Intestine Is Mediated by the Xenobiotic Sensors Pregnane X Receptor (PXR) and Constitutively Activated Receptor (CAR)

4. Differential Time-Dependent Inactivation of P450 3A4 and P450 3A5 by Raloxifene: A Key Role for C239 in Quenching Reactive Intermediates

5. Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control

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