Japanese Bridging Studies

What are clinical trials and clinical trials?

A clinical trial is a study conducted on “humans” to improve methods such as diagnosis, treatment, and prevention of diseases. Among clinical trials, clinical trials are conducted to obtain manufacturing approval for new drugs and new medical devices. Drugs and medical devices refer to those that doctors can write and use in hospitals and clinics, and data showing that these are worthy of FDA (US Food and Drug Administration) approval for manufacturing. The purpose of the clinical trial is to submit.

Why are you recruiting Japanese clinical trial participants?

If the Ministry of Health, Labor and Welfare permits the import and sale of overseas pharmaceuticals and medical equipment, some data from overseas may be diverted, but in principle it is not acceptable that there is no data in Japan, and Japanese people need to present the data. Participation in new drug clinical trials may lead to the collection of necessary data for Japanese people, speeding up the approval process, and delivery to patients in need of new drugs.

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