Additional Strength Biowaiver Requirements [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2020-07-18 03:13 (707 d 13:13 ago) – Posting: # 21738
Views: 1,953

Hi dshah

» I believe 2.5X8 tab Vs 20 mg, 10X2 tab vs 20 mg and 15 vs 20 mg strength using 0.4% SDS media is one of the option, but is there any other options for dissolution comparision?

I am not well versed in Additional Strength Biowaivers but I think one of the basic requirements is that the dissolution media should not contain any surfactant at all.

Scopy

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