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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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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:
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
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author Green, Dionna J.
Park, Kyunghun
Bhatt-Mehta, Varsha
Snyder, Donna
Burckart, Gilbert J.
author_facet Green, Dionna J.
Park, Kyunghun
Bhatt-Mehta, Varsha
Snyder, Donna
Burckart, Gilbert J.
author_sort Green, Dionna J.
collection PubMed
description 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 Subpart B limits research approvable by an institutional review board to research where the risk to the fetus is minimal unless the research holds out the prospect of a direct benefit to the fetus or the pregnant woman (45 CFR 46.204). Research that does not meet these requirements, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health of pregnant women, fetuses, or neonates, may be permitted by the Secretary of the HHS after expert panel consultation and opportunity for public review and comment (45 CFR 46.407). If the product is regulated by the US Food and Drug Administration (FDA), FDA may get involved in the review process. The FDA does however have a Reviewer Guidance on Evaluating the Risks of Drug Exposure in Human Pregnancies from 2005 and this guidance does discuss the intensity of drug exposure. Estimation of that exposure using physiologically based pharmacokinetic (PBPK) modeling has been suggested by some investigators. Given that drug exposure during pregnancy will impact the fetus, a number of new guidances in the last 2 years also address inclusion of pregnant women in clinical drug trials. Therefore, the drug-specific information on fetal pharmacology will increase dramatically in the next decade due to interest in drugs administered in pregnancy and with the assistance of model-informed drug development.
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spelling pubmed-83501262021-08-10 Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling Green, Dionna J. Park, Kyunghun Bhatt-Mehta, Varsha Snyder, Donna Burckart, Gilbert J. Front Pediatr Pediatrics 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 Subpart B limits research approvable by an institutional review board to research where the risk to the fetus is minimal unless the research holds out the prospect of a direct benefit to the fetus or the pregnant woman (45 CFR 46.204). Research that does not meet these requirements, but presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health of pregnant women, fetuses, or neonates, may be permitted by the Secretary of the HHS after expert panel consultation and opportunity for public review and comment (45 CFR 46.407). If the product is regulated by the US Food and Drug Administration (FDA), FDA may get involved in the review process. The FDA does however have a Reviewer Guidance on Evaluating the Risks of Drug Exposure in Human Pregnancies from 2005 and this guidance does discuss the intensity of drug exposure. Estimation of that exposure using physiologically based pharmacokinetic (PBPK) modeling has been suggested by some investigators. Given that drug exposure during pregnancy will impact the fetus, a number of new guidances in the last 2 years also address inclusion of pregnant women in clinical drug trials. Therefore, the drug-specific information on fetal pharmacology will increase dramatically in the next decade due to interest in drugs administered in pregnancy and with the assistance of model-informed drug development. Frontiers Media S.A. 2021-07-26 /pmc/articles/PMC8350126/ /pubmed/34381745 http://dx.doi.org/10.3389/fped.2021.698611 Text en Copyright © 2021 Green, Park, Bhatt-Mehta, Snyder and Burckart. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pediatrics
Green, Dionna J.
Park, Kyunghun
Bhatt-Mehta, Varsha
Snyder, Donna
Burckart, Gilbert J.
Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title_full Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title_fullStr Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title_full_unstemmed Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title_short Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling
title_sort regulatory considerations for the mother, fetus and neonate in fetal pharmacology modeling
topic Pediatrics
url 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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