Utilisation of Human Pharmacology Studies with Biomarkers for New Drug Applications in Japan

Yasuo Kodama,Kazuyuki Saito,Shunsuke Ono,Hirofumi Kodama,Masae Kuranari,Kimiko Tsutsumi,Deborah F. Yaplee,Hiromi Takano-Ohmuro,Mizue Mutoh,Akio Fujimura

Utilisation of Human Pharmacology Studies with Biomarkers for New Drug Applications in Japan

2005

Yasuo Kodama
Kazuyuki Saito
Shunsuke Ono
Hirofumi Kodama
Masae Kuranari
Kimiko Tsutsumi
Deborah F. Yaplee
Hiromi Takano-Ohmuro
Mizue Mutoh
Akio Fujimura

Objective:This study evaluated the utilisation of human pharmacology studies with biomarkers for either efficacy or safety estimation conducted for new drug applications (NDAs) submitted to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).

Keywords:

Alternative medicine
Drug
Christian ministry
Perospirone
Biomarker (medicine)
Pharmacology
Levocabastine
New drug application
Medicine
pharmacology toxicology
regulatory authority

Correction
Source
Cite
Save
Machine Reading By IdeaReader

References

Citations