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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...

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Detalles Bibliográficos
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
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/PMC9294861/
https://www.ncbi.nlm.nih.gov/pubmed/35851758
http://dx.doi.org/10.1002/jia2.25917