Affiliation:
1. Department of Pharmaceutical Sciences University of Colorado Anschutz Medical Campus Aurora Colorado USA
2. Division of Women's Health Research MedStar Health Research Institute Washington District of Columbia USA
3. Skaggs School of Pharmacy and Pharmaceutical Sciences University of California San Diego San Diego California USA
4. Pediatrics Department University of California San Diego School of Medicine‐Rady Children's Hospital San Diego San Diego California USA
Abstract
AbstractPharmacokinetic (PK) studies in pregnant, postpartum, and breastfeeding people are critical to informing appropriate medication use and dosing. A key component of translating PK results in these complex populations into clinical practice involves the systematic review and interpretation of data by guideline panels, composed of clinicians, scientists, and community members, to leverage available data for informed decision making by clinicians and patients and offer clinical best practices. Interpretation of PK data in pregnancy involves evaluation of multiple factors such as the study design, target population, and type of sampling performed. Assessments of fetal and infant drug exposure while in utero or during breastfeeding, respectively, are also critical for informing whether medications are safe to use during pregnancy and throughout postpartum in lactating people. This review will provide an overview of this translational process, discussion of the various factors considered by guideline panels, and practical aspects of implementing certain recommendations, using the HIV field as an example.
Subject
Pharmacology (medical),Pharmacology
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