Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically-Based Pharmacokinetic Modeling: A Regulatory Perspective

Autor: Paola Coppola, Essam Kerwash, Janet Nooney, Susan Cole, Siu Ping Lam
Rok vydání: 2020
Předmět:
Zdroj: CPT: Pharmacometrics & Systems Pharmacology
CPT: Pharmacometrics & Systems Pharmacology, Vol 9, Iss 10, Pp 547-549 (2020)
ISSN: 2163-8306
Popis: It is generally recommended that use of medicines should be avoided during pregnancy, sometimes however use of a medicine is essential to safeguard the health of mother and baby. A very limited number of medicines are however specifically licensed for use in pregnancy. This article considers the potential of PBPK modelling as a predictive tool to investigate the expected systemic exposure of medicines in pregnant women and to support possible dosing adjustment to maintain efficacy.
Databáze: OpenAIRE