Dose Rationale Documents for medications in pregnancy
Hiensch, D.T.A.
Dibbets, C.
This collection contains dose rationale documents (DRDs) developed by Project Madam. Within Project Madam, pregnancy-specific dosing recommendations are developed based on data on the drug’s safety, effectiveness, and pharmacokinetics during pregnancy. These data are obtained through systematic literature review and physiology-based pharmacokinetic (PBPK) modelling. The rationale underlying these dosing recommendations is documented in the DRDs, which are submitted to the national multidisciplinary expert group. The endorsed dosing recommendations are published on the websites of the Dutch Teratology Information Service (Moeders van Morgen, Lareb) and national drug formulary (Farmacotherapeutisch Kompas). The DRDs are accessible via the Radboud Data Repository and our website Projectmadam.org. Version 2 of this collection includes three additional DRDs compared to version 1.