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petekoz1

01/30/10 11:52 AM

#27186 RE: Ubertino #27185

When testing for toxicity blood & urine is used which contain the drug being tested during in vivo preclinical, toxicity studies. However, several innovative in vitro toxicity test procedures are available utilizing non-animal human cell lines and certain chemicals, one is the MEIC Battery process which has proven to be the most effective predictor of human acute toxicity thus eliminating the use of animals & potential animal suffering. As well, these new in vitro toxicity study methods reduce the amount of time, but I understand can be more expensive.

http://www.pcrm.org/resch/PDFs/ae_invitro.pdf

However, NNVC has tested their drugs in over 2000 animals with no toxicity evidenced and all drugs have shown to be biodegradable excreted via normal bowel movements. I wonder if it is possible for NNVC to obtain some kind of waiver of sorts (if such is available from the FDA) regarding the necessity of thorough toxicity studies. I don’t know, but perhaps Dr. Feelgood or someone else may know that answer. I doubt the potential and whether it’s ever been applied for or allowed, but it makes sense.....but then again, common sense & the FDA make for strange bedfellows.