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

• Główni autorzy: Dionna J. Green (Autor), Kyunghun Park (Autor), Varsha Bhatt-Mehta (Autor), Donna Snyder (Autor), Gilbert J. Burckart (Autor)
• Format: Książka
• Wydane: Frontiers Media S.A., 2021-07-01T00:00:00Z.
• Hasła przedmiotowe: article
• Dostęp online: Connect to this object online.

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...