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Dear all,
Can anybody tell me how to calculate low dose required for acute toxicity studies if the molecule is already marketed for human use
-- Regards
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The following message was posted to: PharmPK
Dear Rajendra
Your question is too vague to provide a specific answer - why you would
wish to conduct an acute toxicity test using an approved agent? Whether
it's to study overdosage or potential in a new clinical indication, I
don't understand why you would wish to calculate a low dose for such a
study design - an appropriate dose range would be required to identify
the acute or maximum tolerated dose. Nonetheless, you may find the EMEA
EPARs page a useful resource to uncover some information regarding dose
levels in toxicology studies of marketed drug. Link is below
http://www.emea.europa.eu/htms/human/epar/a.htm
Cheers
Keith
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The following message was posted to: PharmPK
If it is an approved agent, one is best served to go obtain the Summary
Basis for Approval (SBA) document for the compound. This is the data
that is disclosed once a drug is approved by the FDA. They would
normally have information which you can reverse engineer to get what you
need.
Sincerely,
Ving J. Lee
CEO-CSO
Adesis Inc.
New Castle, DE 19720
And
SVP Research-CSO
Limerick Biopharma, Inc.
South San Francisco, CA 94080
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You may wish to use a reverse allometric scale from humans to rodents and then use a margin of safety factor of 10 in your calculations. Short of running a DRF (Dose range finding study) this would be your best starting point. You would also have to know if the drug has AUC or Cmax related tox... its an important consideration.
-- Sanjeev Thohan, PhD
SARx Consulting
SARxconsult.-at-.Gmail.com
http://www.linkedin.com/in/sanjeevthohan
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