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

• Published in: Clinical pharmacokinetics Vol. 62; no. 6; pp. 891 - 904
• Main Authors: Cleary, Yumi, Kletzl, Heidemarie, Grimsey, Paul, Heinig, Katja, Ogungbenro, Kayode, Silber Baumann, Hanna Elisabeth, Frey, Nicolas, Aarons, Leon, Galetin, Aleksandra, Gertz, Michael
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.06.2023; Springer Nature B.V
• Subjects: Adult; Adults; Age; Bioavailability; Child; Cytochrome; Cytochrome P-450 CYP3A - metabolism; Drug Interactions; Enzymes; Humans; Infant; Internal Medicine; Investigations; Medicine; Medicine & Public Health; Metabolism; Models, Biological; NCT; NCT02633709; NCT02908685; NCT02913482; NCT03032172; NCT03988907; Neuromuscular diseases; Original; Original Research Article; Parameter estimation; Pediatrics; Pharmacokinetics; Pharmacology/Toxicology; Pharmacotherapy; Prospective Studies; Proteins

Background and Objective Spinal muscular atrophy (SMA) is a progressive neuromuscular disease caused by insufficient levels of survival motor neuron (SMN) protein. Risdiplam (Evrysdi TM ) increases SMN protein and is approved for the treatment of SMA. Risdiplam has high oral bioavailability and is p...