Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations apply to the fetus. The HHS regulation 45 CFR Part 46...

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Detalles Bibliográficos
Autores principales: Green, Dionna J., Park, Kyunghun, Bhatt-Mehta, Varsha, Snyder, Donna, Burckart, Gilbert J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Pediatrics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8350126/
https://www.ncbi.nlm.nih.gov/pubmed/34381745
http://dx.doi.org/10.3389/fped.2021.698611

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8350126/
https://www.ncbi.nlm.nih.gov/pubmed/34381745
http://dx.doi.org/10.3389/fped.2021.698611

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