Bioequivalence and Bioavailability Forum • Additional Strength Biowaiver Requirements

Additional Strength Biowaiver Requirements [Dissolution / BCS / IVIVC]

posted by Obinoscopy – USA, 2020-07-18 05:13 (2157 d 16:30 ago) – Posting: # 21738
Views: 7,351

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

Complete thread:

Biowaiver for lower strength using different OGD media dshah 2020-07-13 08:09
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  - EMA: No biowaivers for NTIDs Relaxation 2020-07-16 10:54
    - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Helmut 2020-07-16 11:27
      - Biowaiver only for BCS I and – under certain conditions – BCS III drugs Obinoscopy 2020-07-16 14:36
        
        Biowaiver only for BCS I and – under certain conditions – BCS III drugs dshah 2020-07-17 06:27
        
        Additional Strength Biowaiver RequirementsObinoscopy 2020-07-18 03:13
        Additional strength Biowaiver wienui 2020-07-18 18:00