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Hi
I have to calculate human dose of an NCE using preclinical data.
Therefore, I needed advise/suggestions regarding allometic scaling and
most widely used method used in pharmaceutical industry for the same.
I would be very thankful if anyone could provide me with relevant
papers...
Thanks a lot in advance,
Renu
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Dear Renu,
There are lot of references available, I have only mentioned some of
them and they may be of some use to you...
Xenobiotica 2004, vol. 34, no6, pp. 571-579
Antimicrob Agents Chemother. 2001 October; 45(10): 2787-2792
Regards,
Martin
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The following message was posted to: PharmPK
A good reference for HED estimates is the FDA guidance on 'Estimating
the maximum safe starting dose in initial clinical trials for
therapeutics'. Click on the link below:
http://www.fda.gov/cder/guidance/5541fnl.htm
Yomi
--
Abayomi Ogundele, Pharm.D.
Sr. Scientist II (DEV)
Clinical Pharmacology Group
Alcon Laboratories Inc.
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Hi Renu,
You may want to start with the US FDA guidelines on estimating safe
starting dose in healthy volunteers. The guidance document is
available at
http://www.fda.gov/cder/guidance/5541fnl.pdf
Thanks
Ganesh
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Dear Renu,
You can refer the book entitled 'Interspecies PK scaling' by Iftekhar
Mahmood.
It includes various approaches for human dose estimation including HED.
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Hi Renu,
Check the following article for easy and simple approach. Interspecies
prediction of human drug clearance based on scaling data from one or
two animal species. Drug Metab Dispos. 2007 Oct;35(10):1886-93.
Regards,
Azher
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