Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.

Obstetrics and Gynecology
Daniel GonzalezMichael Cohen-Wolkowiez

Abstract

Children and pregnant women are vulnerable populations lacking clinical data to guide drug dosing. For children, over the past 15 years, the knowledge gap in pharmacokinetic, safety, and efficacy data has been narrowed as a result of the use of innovative clinical trial designs, minimal risk research methods, increased understanding of developmental pharmacology, multidisciplinary research teams, increased clinical pharmacology expertise and training, collaborative research networks, and critical legislative changes. This progress has not been observed to a similar degree for pregnant women. These two populations, however, share similar drug development challenges and, therefore, lessons learned in pediatric clinical trials can be leveraged to advance drug development in pregnant women.

References

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Citations

May 27, 2015·American Journal of Obstetrics and Gynecology·Gerald G BriggsCraig V Towers
Sep 12, 2015·Seminars in Perinatology·Martina Ayad, Maged M Costantine
Oct 11, 2016·Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'obstétrique Et Gynécologie Du Canada : JOGC·Sophie PalmerRobert L Reid
Mar 10, 2018·The Annals of Pharmacotherapy·Brooke L GriffinAnahit Simonyan
Jan 17, 2019·American Journal of Public Health·Alan R HinmanWalter A Orenstein
Sep 20, 2017·British Journal of Clinical Pharmacology·Sílvia M IllamolaAnne Zajicek
Apr 20, 2020·Journal of Pharmacokinetics and Pharmacodynamics·Monique McKieverMaged M Costantine
Apr 23, 2021·American Journal of Obstetrics and Gynecology·Zhaoxia RenAaron C Pawlyk
May 18, 2021·Frontiers in Pharmacology·Raju KhatriCraig R Lee
Nov 6, 2021·Expert Opinion on Drug Metabolism & Toxicology·Ian R MulreninCraig R Lee
Aug 6, 2017·Pediatrics·Delesha CarpenterBenjamin Wilfond
Dec 15, 2021·British Journal of Clinical Pharmacology·Jamil M KazmaHoma K Ahmadzia

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