velupharm
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2006-07-31 09:16

Posting: # 191
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 Comparision of Dissolution profile [Dissolution / BCS / IVIVC]

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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?
 
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