Surfactant in Biowaiver media [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2014-12-16 06:29 (3858 d 16:51 ago) – Posting: # 14075
Views: 5,549

Hi Amira/Helmut

Which biowaiver we are talking about?
a) If BCS based biowaiver to be proposed then NEVER
b) If biowaiver for strengths other than bio strength: YES but need to provide sufficient justification/Data for usage of surfactant (especially in case of BCS class II/IV drugs, one have to add surfactant to show complete release)

~A happy Soul~

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