EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals-Reference-Cited by-同舟云学术

EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

Published:2023-06-02 Issue:8 Volume:89 Page:2341-2348
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

van der Laan Jan Willem¹²³,Andersson Mikael⁴,Beken Sonja⁵,Bonelli Milton⁶,Brendler‐Schwaab Susanne⁷,Kane Rosemary⁸,Pasanen Markku²⁹,Ponzano Stefano⁶,Paur Jakob¹⁰,Siezen Christine¹,Soleng Anne¹¹,Whomsley Rhys⁶^ORCID

Affiliation:

1. Medicines Evaluation Board Utrecht The Netherlands

2. ICH S1 Expert Working Group European Medicines Agency Amsterdam The Netherlands

3. Division of Drug Discovery and Safety Leiden Academic Centre for Drug Research, University of Leiden Leiden Netherlands

4. Medical Products Agency Uppsala Sweden

5. Federal Agency for Medicines and Health Products Brussels Belgium

6. European Medicines Agency Amsterdam The Netherlands

7. Federal Institute for Drugs and Medical Devices (BfArM) Bonn Germany

8. Health Products Regulatory Authority Dublin Ireland

9. School of Pharmacy University of Eastern Finland Kuopio Finland

10. Austrian Medicines and Medical Devices Agency (AGES) Vienna Austria

11. Norwegian Medicines Agency Oslo Norway

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15790

Reference44 articles.

1. ICH topic S1B. Testing for carcinogenicity of pharmaceuticals part II S1B‐R1_FinalGuideline_2022_0719.pdf(ich.org).

2. ICH S1A. Guideline on the need for carcinogenicity studies of pharmaceuticals.S1A Guideline.pdf(ich.org) (checked February 28 2023).

3. ICH topic S1B. Carcinogenicity: testing for carcinogenicity of pharmaceuticals. Step 4 consensus guideline. Part I.S1B‐R1_FinalGuideline_2022_0719.pdf(ich.org).

4. ICH topic S1C. Dose selection for carcinogenicity studies of pharmaceuticals.S1C(R2) Guideline.pdf(ich.org) (checked February 28 2023).