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

INTRODUCTION: To allow the continued participation of women enrolled in pre‐licensure clinical trials who become pregnant, and to potentially enrol pregnant women in clinical trials, non‐clinical developmental and reproductive toxicology studies (DART) are essential. Generally during pharmaceutical...

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Detalles Bibliográficos
Autores principales: Greupink, Rick, van Hove, Hedwig, Mhlanga, Felix, Theunissen, Peter, Colbers, Angela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9294860/
https://www.ncbi.nlm.nih.gov/pubmed/35851570
http://dx.doi.org/10.1002/jia2.25914

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