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Additional excipient justification [Dissolution / BCS / IVIVC]

posted by nobody – 2014-11-30 21:44 (4216 d 19:46 ago) – Posting: # 13958
Views: 8,000

afaik only WHO considers (some limited) class II APIs egligilbe for biowaivers. Look up literature for ibuprofen to have details on limitations for this approach, has been discussed here in the past iirc...

Regards

nobody

—
Kindest regards, nobody

Complete thread:

Additional excipient justification srinivasuk 2014-11-30 08:53
- Biowaiver for BCS Class II? Helmut 2014-11-30 14:24
- Additional excipient justificationnobody 2014-11-30 20:44
  - Additional excipient justification Dr_Dan 2014-12-02 09:34
    - Additional excipient justification nobody 2014-12-02 10:38

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