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nidan7500

06/27/20 12:08 PM

#256530 RE: tredenwater2 #256524

[quot]e Do you mean reproducible as in at the unmasking verifieng who was on placebo and who was on which dose[/quote]

It gets a little complicated but generally one must follow the steps outlined starting here. No doubt this has already been done as part of trial planning/execution.

https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
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McMagyar

06/27/20 3:05 PM

#256557 RE: tredenwater2 #256524

Oh we are close

Any delay is crossing g the t’s and dotting the i’s