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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...
Autores principales: | Greupink, Rick, van Hove, Hedwig, Mhlanga, Felix, Theunissen, Peter, Colbers, Angela |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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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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