title: Industry Perspective of Drug Development for Pregnant/Breastfeeding Women.
abstract: As part of drug development, drug companies conduct experiments to gather data about the potential toxicity of medications in pregnant and lactating animals. Increasingly, physiologically based pharmacokinetic models are developed to simulate drug concentrations in pregnant and lactating women. As these women are not usually included in clinical trials, targeted postapproval safety monitoring, registries, or clinical studies may be performed to gather safety and efficacy information about drug use in these special populations.
authors.affiliation: Clinical Pharmacology, Pfizer, Collegeville, Pennsylvania, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Korth-Bradley
mesh_terms: D000818:Animals; D001942:Breast Feeding; D015195:Drug Design; D004345:Drug Industry / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007774:Lactation; D008954:Models, Biological; D010599:Pharmacokinetics; D011247:Pregnancy