Origin and generic dugs
Posted: Thu Jan 27, 2005 8:26 pm
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.
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.