Strategy for CYP3A Induction Risk Assessment from Preclinical Signal to Human: a Case Example of a Late-Stage Discovery Compound

Purpose The exposure of G2917 decreased by four-fold at oral doses of 100 mg/kg twice daily for seven days in cynomolgus monkeys. Additional investigative work was conducted to understand: (1) the causes for the significant reduction in G2917 exposure in monkeys; (2) the extrapolation of in vitro in...

Ausführliche Beschreibung

Gespeichert in:

Bibliographische Detailangaben
Veröffentlicht in:	Pharmaceutical research 2017-11, Vol.34 (11), p.2403-2414
Hauptverfasser:	Mao, Jialin, Fan, Peter, Wong, Susan, Wang, Jianshuang, Ismaili, Moulay Hicham Alaoui, Dean, Brian, Hop, Cornelis E. C. A., Wright, Matthew, Chen, Yuan
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Oral Animals Biochemistry Bioindicators Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Computer Simulation Cortisol Cytochrome P-450 CYP3A - biosynthesis Drug Discovery Drug dosages Drug Interactions Enzyme Induction Exposure Extrapolation Humans Hydrocortisone - analogs & derivatives Hydrocortisone - metabolism Hydroxycholesterols - metabolism Liability Liver Liver - drug effects Liver - metabolism Macaca fascicularis Medical Law Medical research Medicine, Experimental Midazolam - pharmacology Models, Biological Monkeys Pharmacokinetics Pharmacology/Toxicology Pharmacy Research Paper Rifampin - pharmacology Risk assessment RNA, Messenger - biosynthesis Toxicology
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!

Schreiben Sie den ersten Kommentar!