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12:00 AM
Jul 25, 2005
 |  BioCentury  |  Regulation

FOBs according to BIIB

FOBs according to BIIB

Study type Required comparison Probability of success
Biochemical Statistical equivalency on measured parameters and acceptable ranges (innovator vs. follow-on) Low-moderate: Sample 10-12 lots of originator compound purchased from different geographic regions for comparison to 10-12 follow-on batches, data collected over...

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