What's the problem? [Regulatives / Guidelines]

posted by nobody – 2017-05-17 09:48 (2497 d 20:22 ago) – Posting: # 17362
Views: 21,804

❝ ...If you have 20 reports with a CV of 11% and one with a CV of 41% then you start wondering.


OK, and (as a regulator) what are the options? Start an inspection of the CRO? Find some other "good reason" not to grant MA to the pile of trash high quality generic developed in a scientifically advanced pharmaceutical company with cutting edge technology?

Kindest regards, nobody

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