Estimation of FMO3 Ontogeny by Mechanistic Population Pharmacokinetic Modelling of Risdiplam and Its Impact on Drug –Drug Interactions in Children

ConclusionMech-PPK modelling successfully estimated in vivo FMO3 ontogeny from risdiplam data collected from 525 subjects aged 2 months –61 years. To our knowledge, this is the first investigation of in vivo FMO3 ontogeny by population approach using comprehensive data covering a wide age range. Derivation of a robust in vivo FMO3 ontogeny function has significant implications on the prospective prediction of PK and DDI in childr en for other FMO3 substrates in the future, as illustrated in the current study for FMO3 and/or dual CYP3A-FMO3 substrates.Clinical Trial Registry NumbersNCT02633709, NCT03032172, NCT02908685, NCT02913482, NCT03988907.
Source: Clinical Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research