It is my position with our R&D and Marketing folks that any product
to be used on humans (ie clinical study) for safety or efficacy must
be produce in acordance with GMP's.
Having said that how are people meeting the burdens associated with
validation and stability on batches that may be early on or one offs
for testing such as RIPT. And what is a reasonable docssier content
to require of my R&D and Marketing friend prior to allowing a batch
to be released for use in a studiy such as RIPT.
Thank in advance
Mark
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