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Re: tredenwater2 post# 256524

Saturday, 06/27/2020 12:08:37 PM

Saturday, June 27, 2020 12:08:37 PM

Post# of 516501
[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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