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Can someone out there update me on how much PEG400 or DMSO can
beadministered with an IV run under GLP or non-GLP conditions for
toxicity in dog? ThanksAnila
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The following message was posted to: PharmPK
Dear Anila,
The excipients you have mentioned should be avoided to be used in safety
studies, be it is investigational or regulatory. These can be used in
early
preclinical efficacy specially DMSO. PEG 400 can be used up to 1g/Kg/
day as
per EMEA data. There are various ways of formulating avoiding these
excipients, however they can be used if unavoidable but a vehicle
control
should run for a complete safety profile as well.
regards,
V. Sihorkar
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Dear Anila,
The following article may be of help to you
Expert Opin. Drug Metab. Toxicol. (2006) 2(5)
Regards
L. Chakradhar
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