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Maternal–Fetal Drug Development: An Industry Perspective

Medicines and vaccines prescribed to pregnant women often have not had pregnant women or lactating women included in clinical trials and products are often not approved by regulatory agencies for use in pregnant women. As a result, practitioners may need to prescribe medicines and give vaccines to t...

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Detalles Bibliográficos
Autores principales: Burnham, Janelle, Darsey, Edress
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/PMC9541578/
https://www.ncbi.nlm.nih.gov/pubmed/36106788
http://dx.doi.org/10.1002/jcph.2124
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author Burnham, Janelle
Darsey, Edress
author_facet Burnham, Janelle
Darsey, Edress
author_sort Burnham, Janelle
collection PubMed
description Medicines and vaccines prescribed to pregnant women often have not had pregnant women or lactating women included in clinical trials and products are often not approved by regulatory agencies for use in pregnant women. As a result, practitioners may need to prescribe medicines and give vaccines to this special population with limited drug efficacy and safety information available. Multiple regulatory guidance documents regarding the development of medications for pregnant and lactating women have been developed to encourage drug development and the investigation of medicines and vaccines used in this population. However, clinical, regulatory, ethical, and drug development challenges are encountered when designing clinical trials that include pregnant women and their fetuses, in which innovative methods and trial designs are essential. This article provides an overview of an industry perspective on maternal–fetal drug development that includes a review of the regulatory landscape for developing medicines for pregnant women and their fetuses, trial designs that include pregnant women, identification of gaps and challenges, and strategies for potential maternal–fetal drug development considerations for the future development of medicines and vaccines for pregnant women. Early involvement and discussion of drug and vaccine products with multiple stakeholders, including therapeutic experts, patients, physicians, and regulators, is encouraged to optimize the development of safe and effective medicines and vaccines for pregnant women and their fetuses.
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spelling pubmed-95415782022-10-14 Maternal–Fetal Drug Development: An Industry Perspective Burnham, Janelle Darsey, Edress J Clin Pharmacol Supplement Articles Medicines and vaccines prescribed to pregnant women often have not had pregnant women or lactating women included in clinical trials and products are often not approved by regulatory agencies for use in pregnant women. As a result, practitioners may need to prescribe medicines and give vaccines to this special population with limited drug efficacy and safety information available. Multiple regulatory guidance documents regarding the development of medications for pregnant and lactating women have been developed to encourage drug development and the investigation of medicines and vaccines used in this population. However, clinical, regulatory, ethical, and drug development challenges are encountered when designing clinical trials that include pregnant women and their fetuses, in which innovative methods and trial designs are essential. This article provides an overview of an industry perspective on maternal–fetal drug development that includes a review of the regulatory landscape for developing medicines for pregnant women and their fetuses, trial designs that include pregnant women, identification of gaps and challenges, and strategies for potential maternal–fetal drug development considerations for the future development of medicines and vaccines for pregnant women. Early involvement and discussion of drug and vaccine products with multiple stakeholders, including therapeutic experts, patients, physicians, and regulators, is encouraged to optimize the development of safe and effective medicines and vaccines for pregnant women and their fetuses. John Wiley and Sons Inc. 2022-09-15 2022-09 /pmc/articles/PMC9541578/ /pubmed/36106788 http://dx.doi.org/10.1002/jcph.2124 Text en © 2022 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Supplement Articles
Burnham, Janelle
Darsey, Edress
Maternal–Fetal Drug Development: An Industry Perspective
title Maternal–Fetal Drug Development: An Industry Perspective
title_full Maternal–Fetal Drug Development: An Industry Perspective
title_fullStr Maternal–Fetal Drug Development: An Industry Perspective
title_full_unstemmed Maternal–Fetal Drug Development: An Industry Perspective
title_short Maternal–Fetal Drug Development: An Industry Perspective
title_sort maternal–fetal drug development: an industry perspective
topic Supplement Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9541578/
https://www.ncbi.nlm.nih.gov/pubmed/36106788
http://dx.doi.org/10.1002/jcph.2124
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