Supac-mr

[jllewelyn]

When determining if excipients rate a level 1, 2, or 3 change should a comparison be made against all strengths? In other words, does the w/w% of excipient in a 100 mg get compared to the w/w% of excipient in a 25 mg formulation if the 25 mg is to be included in an SNDA post-approval?

In addition, if there are several strengths approved, how do you go about choosing which strength to compare the 25 mg to?

Thanks