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Re: Ubertino post# 39935

Wednesday, 10/13/2010 5:11:59 PM

Wednesday, October 13, 2010 5:11:59 PM

Post# of 146240
You need FDA approval to market a drug for animals - you don't need it to conduct toxicology testing - but you do need a certified cGMP facility. Those facilities are expensive and no companies have captive ones. You go to a provider who has capacity (takes months to get) and pay them. Chimps are very expensive and not great HIV surrogates - most people roll the dice and do two-species tox with smaller animals and don't bother with disease models - trust the cell culture ADME work and hope efficacy happens in humans.
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