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What's the problem? [Regulatives / Guidelines]

posted by kumarnaidu - Mumbai, India, 2017-07-11 14:43  - Posting: # 17533
Views: 9,678

Hi all,
Recently we did pilot and pivotal (Partial reference replicate) studies for WHO and we got high variability (CV=32%). In the USFDA product specific guidance they have suggested 2x2 crossover design for this drug. Based on our prior experience can we perform reference replicate study or need to go as per guidance?:confused:

Kumar Naidu

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