Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels-Reference-Cited by-同舟云学术

Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels

Published:2022-05-05 Issue:2 Volume:113 Page:226-245
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Bowman Christopher J.¹^ORCID,Becourt‐Lhote Nathalie²,Boulifard Virginie³,Cordts Rüdiger⁴,Corriol‐Rohou Solange⁵^ORCID,Enright Brian⁶,Erkman Linda⁷,Harris Jayne⁸,Hartmann Andreas⁷,Hilpert Jan⁹,Kervyn Sophie¹⁰,Mattson Britta¹¹,Morford LaRonda¹²,Muller Mireille¹³,Powell Marcy¹⁴,Sobol Zhanna¹¹,Srinivasan Rajamuthu¹⁵,Stark Claudia¹⁶,Thompson Kary E.¹⁷^ORCID,Turner Katie J.¹⁷,Barrow Paul¹⁸

Affiliation:

1. Worldwide Research, Development, and Medical Pfizer Inc Groton Connecticut USA

2. Nonclinical Safety, Translational Medicine Servier Gidy France

3. Ipsen Pharma Les Ulis France

4. Boehringer Ingelheim Pharma GmbH & Co. KG Biberach Germany

5. Global Regulatory Policy, R&D AstraZeneca Paris France

6. Preclinical Safety AbbVie Inc. North Chicago Illinois USA

7. Preclinical Safety Novartis Pharma Basel Switzerland

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

9. Translational Medicine, Pharma Research and Early Development Bayer AG Berlin Germany

10. UCB Pharma Braine‐l'Alleud Belgium

11. Merck & Co., Inc. West Point Pennsylvania USA

12. Lilly Research Laboratories Indianapolis Indiana USA

13. Regulatory Policy Novartis Pharma Basel Switzerland

14. GlaxoSmithKline Research Triangle Park North Carolina USA

15. Sanofi Pasteur Marcy L’Etoile France

16. Preclinical Development, Pharma Research and Early Development Bayer AG Berlin Germany

17. Nonclinical Safety Janssen Pharmaceuticals Spring House Pennsylvania USA

18. Pharma Research and Early Development F. Hoffmann‐La Roche Ltd. Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2602

Reference84 articles.

1. Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model

2. ICH.S2(R1) harmonised tripartite guideline. Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (2011).

3. ICH.S5(R3) Guidance on detection of reproductive and developmental toxicity for human pharmaceuticals (2020).

4. ICH.M3(R2) Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (2009).

5. Evolving knowledge of the teratogenicity of medications in human pregnancy

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