Table 1.

Need for designed pharmacological studies performed during pregnancy, lactation and postpartum.

Scope of the problem

Contributors to the problem

• Inadequate pharmacological studies performed during pregnancy, lactation and postpartum • Limited data on pregnancy mediated changes in drug exposure and response • Optimal dosing for pregnant, lactating, postpartum women unclear for most medications • Impact of drug exposure on fetal growth and development is unclear for almost all medications used during pregnancy • Limited data on drug transfer through breast feeding • Limited incentive for industries (safety—liability issues)

• Pregnancy is an exclusion in most clinical trials • Inadequate funding for clinical pharmacology research in pregnant, lactating and postpartum women • Inadequate number of investigators qualified to perform or engaged in such studies • Inconvenient study designs for participants • Need for innovative sampling techniques and modeling approaches