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The following message was posted to: PharmPK
Dear Colleagues,
I have synthetised a drug as antibiotic and would like to perform
preclinical studies testing. Therefore I am looking for SOPs for Pk/Pd
and toxicity to be accecpted by FDA..
Any help where I can get these. Thanks
Regards
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Dear Abdelwahab,
If your lab isn't already set up to run these kind of studies, you
might consider doing the work with a reputable CRO (contract testing
organization) lab, since they are set up to do non-GLP and GLP work for
FDA submissions and can provide guidance and options on different
strategies for you.
Adrian Sheldon, Ph.D.
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