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Clinical and population‐based study design considerations to accelerate the investigation of new antiretrovirals during pregnancy
INTRODUCTION: Pregnant women are routinely excluded from clinical trials, leading to the absence or delay in even the most basic pharmacokinetic (PK) information needed for dosing in pregnancy. When available, pregnancy PK studies use a small sample size, resulting in limited safety information. We...
Autores principales: | Brummel, Sean S., Stringer, Jeff, Mills, Ed, Tierney, Camlin, Caniglia, Ellen C., Colbers, Angela, Chi, Benjamin H., Best, Brookie M., Gaaloul, Myriam El, Hillier, Sharon, Jourdain, Gonzague, Khoo, Saye H., Mofenson, Lynne M., Myer, Landon, Nachman, Sharon, Stranix‐Chibanda, Lynda, Clayden, Polly, Sachikonye, Memory, Lockman, Shahin |
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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/PMC9294861/ https://www.ncbi.nlm.nih.gov/pubmed/35851758 http://dx.doi.org/10.1002/jia2.25917 |
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