Non‐clinical considerations for supporting accelerated inclusion of pregnant women in pre‐licensure clinical trials with anti‐HIV agents-Reference-Cited by-同舟云学术

Non‐clinical considerations for supporting accelerated inclusion of pregnant women in pre‐licensure clinical trials with anti‐HIV agents

Published:2022-07 Issue:S2 Volume:25 Page:
ISSN:1758-2652
Container-title:Journal of the International AIDS Society
language:en
Short-container-title:J Int AIDS Soc.

Author:

Greupink Rick¹^ORCID,van Hove Hedwig¹^ORCID,Mhlanga Felix²^ORCID,Theunissen Peter³^ORCID,Colbers Angela⁴^ORCID

Affiliation:

1. Department of Pharmacology and Toxicology Radboud Institute of Molecular Life Sciences Nijmegen Netherlands

2. UZ‐UCSF Collaborative Study in Women's Health Zimbabwe Harare Zimbabwe

3. CBG‐MEB Utrecht Netherlands

4. Department of Pharmacy Radboud Institute for Health Sciences Nijmegen Netherlands

Publisher

Wiley

Subject

Infectious Diseases,Public Health, Environmental and Occupational Health

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jia2.25914

Reference23 articles.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).ICH guideline M3(R2) on non‐clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals.2009. Available from:https://database.ich.org/sites/default/files/M3_R2__Guideline.pdf. Accessed 11 April 2022.

2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).Detection of reproductive and developmental toxicity for human pharmaceuticals S5(R3).2020. Available from:https://database.ich.org/sites/default/files/S5‐R3_Step4_Guideline_2020_0218_1.pdf. Accessed 11 April 2022.

3. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).Preclinical safety evaluation of biotechnology‐derived pharmaceuticals S6(R1).2011. Available from:https://database.ich.org/sites/default/files/S6_R1_Guideline_0.pdf. Accessed 11 April 2022.

4. World Health Organization.Approaches to enhance and accelerate study of new drugs for HIV and associated infections in pregnant women: meeting report.2021. Available from:https://www.who.int/publications/i/item/9789240040182. Accessed 11 April 2022.

5. World Health Organization.Conference on ARV Drug Optimization (CADO).2022. Available from:https://www.who.int/groups/antiretroviral‐drug‐optimization. Accessed 11 April 2022.

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Developmental safety of nirmatrelvir in zebrafish ( Danio rerio ) embryos;Birth Defects Research;2022-11-14

2. Disrupting the status quo to achieve early inclusion of pregnant women in studies of new agents for prevention and treatment of HIV infection;Journal of the International AIDS Society;2022-07

3. Accelerating investigation of new HIV drugs in pregnancy: advancing the research agenda from theory to action;Journal of the International AIDS Society;2022-07

4. Approaches to accelerating the study of new antiretrovirals in pregnancy;Journal of the International AIDS Society;2022-07