FDA IND Requirements

pharma2005 p_raghunathan at hotmail.com
Thu Jan 13 21:05:24 EST 2005


Hello
Does anyone know what are the quality requirements for drug compounds
used in pre-clinical toxicity and efficacy tests leading upto the IND
filing.  Does FDA require the compounds to be GLP grade? Or is there a
purity threshold?

Regards and thanks in advance

Partha Raghunathan
Symbiotic Therapeutics




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