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Dear all,
I believe FDA has produced a guideline for first in man studies. Could
anybody tell me where I can find an electronic version of this
document?
Best regards,
Toufigh Gordi
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Toufigh,
There are numerous guidance documents related to first in man studies
on the FDA web site. Here is the link to the guidance page:
http://www.fda.gov/cder/guidance/
Regards,
Frank
Frank Bales, Ph.D.
Senior Regulatory Consultant
Worldwide Regulatory Affairs
PAREXEL Intl.
2520 Meridian Pkwy, Suite 200
Durham, NC 27713
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Toufigh,
You can locate all of FDA's Guidelines starting at
http://www.fda.gov/cder/index.html
Check out our Regulations and Guidelines section for other possibly
relevant sites and sources at www.SummitPK.com/links/links.htm
Regards,
David
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Montrose, CO 81401 Web: http://www.SummitPK.com
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Please find the link that would lead you to the
calculation of safe string dose for First in Man
studies.
http://www.fda.gov/cder/guidance/1855fnl.pdf
Hope this helps...
Regards
Ganesh
Ranbaxy Clinical Pharmacology Unit
INDIA
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Dear Toufigh
Perhaps is it this one you are looking for:
"Estimating the Safe Starting Dose in Clinical Trials for Therapeutics
in
Adult Healthy Volunteers"
http://www.fda.gov/cder/guidance/3814dft.pdf ?
Regards,
Fabrice
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)