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Back to the forum  Query: 2018-05-20 10:11 UTC (UTC+2h)

What's the problem? [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2017-07-11 12:56  - Posting: # 17534
Views: 5,512

» 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:

You probably have both options available. However, the gain with CV=32% is minute; I mean if you have a CVr of 32% in a replicate study you are widening the limits so minutely that I think it isn't worth the effort. At the end of the day those (semi)replicated are still far less routine than the standard 222BE jobs. And IEC's can have a lot of funny ideas when they review your protocol etc.

That said, I'd like to know the background better before saying this is my final answer :-)

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).

Best regards,

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.

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