Impact of "guidance for industry: clinical pharmacokinetic studies of pharmaceuticals" on new drug approvals of central nervous system drugs in Japan

Drug Metab Pharmacokinet. 2011;26(1):117-20. doi: 10.2133/dmpk.dmpk-08-cm-054. Epub 2010 Oct 22.

Authors

Susumu Nakade¹, Junsaku Kitagawa, Tomoya Ohno, Chihiro Amano, Naoki Honda, Yasuo Kodama, Mikio Ogawa

Affiliation

¹ Pharmacokinetic Research Laboratories, Ono Pharmaceutical Co., Ltd., Wadai, Tsukuba, Ibaraki, Japan. snakade@ono.co.jp

PMID: 20978363
DOI: 10.2133/dmpk.dmpk-08-cm-054

No abstract available

MeSH terms

Asian People
Biomedical Research
Central Nervous System Agents / pharmacokinetics*
Drug Approval / legislation & jurisprudence
Drug Approval / methods*
Humans
Japan

Substances

Central Nervous System Agents