You may have a plan to launch your new drug in Japanese market. Submission J-NDA or License out.
Japanese Data in global phase 3 studies are essential.
PK data and/or Safety data with Japanese subjects is necessary for initiating a global phase 3 study
Including 6-8 Japanese nationals in phase 1 studies will dramatically increase the VALUE of the data of your drug, as it will add the third largest market in the world.
Japanese Data in global phase 3 studies are necessary for approvals in Japan
When you initiate a Global Phase 3 study in Japan, prior PK data and/or Safety data with Japanese subjects will be required. Phase 1/PK studies including Japanese cohort are effective in the speedy clinical development.
(Guideline: MHLW Notification No. 0928010, September 28, 2007: Basic principles on Global Clinic Trials.)
The study including a Japanese cohort should be conducted in the US
HGMI Health recommends that the standard safety/PK study including a Japanese cohort be conducted in the US.
It will produce enough data for the future global phase 3 studies including Japanese population in the least expensive and fastest way.
HGMI Health ensures that Japanese phase 1 studies are successfully conducted in the US and the application is acceptable to the Japanese authority.