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leifsmith

01/31/14 11:13 AM

#79426 RE: davidc2 #79425

That's not an effective answer to my question.

Why not?

Because you ask me to assume that because the company didn't mention multiple animals until now that they did not know multiple animals would be required.

I claim that they have always known that complete toxicology studies require multiple species.

You claim that they could not have known this because they just told us about it.

Do you really think you are making a rational case here?
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BonelessCat

01/31/14 11:29 AM

#79429 RE: davidc2 #79425

Because it is part of the final toxicology work and not part of the efficacy and proof of concept studies. Using the final form of the drug, the toxicology is performed across 3 species to determine a safe starting point for the first dose and to get a range of dose possibilities for the escalation, several possible highest doses. They use the most sensitive species outcomes to determine a safe starting dose. Then they examine the pharmacokinetics to see how long the drug remains in the system for each species and how each species processes and eliminates the drug to get an idea of cross species differences. This also gives insight into what might be anticipated as problems especially if each species processes and eliminates a drug quite differently. None of this can be done earlier.