Impact of “Guidance for Industry: Clinical Pharmacokinetic Studies of Pharmaceuticals” on New Drug Approvals of Central Nervous System Drugs in Japan

「Background」 A pharmacokinetic (PK) study, which is classified as one of the human pharmacology studies defined by the ICH-E8 guideline,1) has become a critical component of a complete clinical data package for new drug application (NDA).2) While the three preliminary studies, single-dose, multipled...

Ausführliche Beschreibung

Bibliographische Detailangaben

Veröffentlicht in:	DRUG METABOLISM AND PHARMACOKINETICS 2011-01, Vol.26 (1), p.117-120
Hauptverfasser:	Nakade, Susumu, Kitagawa, Junsaku, Ohno, Tomoya, Amano, Chihiro, Honda, Naoki, Kodama, Yasuo, Ogawa, Mikio
Format:	Artikel
Sprache:	eng
Schlagworte:	Asian Continental Ancestry Group Biomedical Research central nervous system Central Nervous System Agents - pharmacokinetics clinical pharmacokinetics Drug Approval - legislation & jurisprudence Drug Approval - methods Humans Japan MHLW guidance new drug application
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!