Table of Contents
NICHD Perspective on Needs for the Study of Therapeutic Drug Use in Pregnancy
Issues
Therapeutic drug use is common and required in pregnancy for:
Maternal conditions commonly requiring therapy in pregnancy
Pregnancy-related conditions commonly requiring therapy
Fetal conditions commonly requiring drug therapy
Drug therapy in pregnancy
Pregnancy: Maternal physiologic changes affect therapeutic drug administration
Pregnancy: Cardiovascular changes
Pregnancy: Cardiovascular changes
Pregnancy: Cardiovascular changes
Gastrointestinal changes
Consequences of physiologic changes:
Consequences of physiologic changes:
Timing: Effect of gestational age
Maternal fetal transfer
Monitoring fetal drug levels
Ethical considerations & study design
NICHD & FDA Initiatives:
Bottom line
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