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Origin and generic dugs

Posted: Thu Jan 27, 2005 8:26 pm
by nihal
Hi,
When we compare type and limit of related impürities in drug product
specifications , what types of differences should be mostly involved in origin drug product spesifications and generic drug product spesifications? I have no found enough information comperatively in ICH and FDA guidances.
Thank you for now.

Posted: Fri Jan 28, 2005 5:34 pm
by maris
Go to http://www.fda.gov/cder/guidance/2452fnl.htm

FDA gives you a very clear regulations