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RegisterComparision of Dissolution profile [Dissolution / BCS / IVIVC]
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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?
Complete thread:
- Comparision of Dissolution profile velupharm 2006-07-31 09:16
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