Most drug labels do not provide dosing guidance for pregnant and lactating women, yet in the U.S. alone, more than 6 million women are pregnant each year, and it is estimated that more than 90 percent take at least one medication while pregnant or lactating. Simcyp has developed and published papers on its time varying models which consider physiological changes impacting pharmacokinetics over the entire gestational life cycle, as well as both mother and baby after birth. In this webinar, maternal dosing for a number of case studies was be shared, including the concept of dose adjustments for different stages during this cycle, impacting the mother and the fetus. We also discussed prediction of milk drug exposure in breastfeeding mothers and estimation of infant dose and infant risk assessment.
