Comparision of Dissolution profile [Dissolution / BCS / IVIVC]
Daer all
for US-FDA,when we do a biostudy with highest strength and asked for a biowaiver of lower strengths,should the dissolution proile be matched with corresponding doses of the innovator or within the different strengths of our own product or both the ways?
for US-FDA,when we do a biostudy with highest strength and asked for a biowaiver of lower strengths,should the dissolution proile be matched with corresponding doses of the innovator or within the different strengths of our own product or both the ways?