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The assessment of drug safety for the fetus

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Long standing concerns regarding the use of medications during pregnancy and their unknown effects on fetal development and child health suggests the need for modified study methods regarding the establishment… Click to show full abstract

Long standing concerns regarding the use of medications during pregnancy and their unknown effects on fetal development and child health suggests the need for modified study methods regarding the establishment of drug safety for the fetus. This Current Commentary highlights several pharmacological study method limitations and offers suggestions for the establishment of drug safety for the fetus. For example, extensive phase 1 pharmacology studies are needed to assess the complex pharmacokinetic relationships between mother and fetus in order to determine injurious doses to the fetus throughout pregnancy. In addition, long term randomized clinical trials are needed to assess the effects medications may have on children following exposure during gestation.

Keywords: drug safety; assessment drug; safety fetus

Journal Title: International Journal of Clinical Pharmacy
Year Published: 2020

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