LEXICON
No.106 March 19, 2012

“True” clinical benefits
真の臨床的有用性
Usefulness or utility
有用性(日本の臨床試験において)

The FY2010 NHI pricing system reform introduced a premium for existing drugs with “true” clinical benefits (真の臨床的有用性) that had been unknown at the time of the initial NDA submission and that were thereafter demonstrated based on post-marketing clinical studies conducted...

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