Bioequivalence and Bioavailability Forum • FDA - Biowaiver Class III

FDA - Biowaiver Class III [Regulatives / Guidelines]

posted by jag009 – NJ, 2015-05-14 18:31 (3565 d 23:45 ago) – Posting: # 14820
Views: 4,097

❝ Yep. Samaya notified us last week.

And the Test and Ref need to be super fast in dissolution time. 15 mins... for Class 3

For Class 1 they only ask for within 30mins...

John

Complete thread:

FDA - Biowaiver Class III nobody 2015-05-12 10:01 [Regulatives / Guidelines]
- FDA - Biowaiver Class III Helmut 2015-05-12 12:27
  - FDA - Biowaiver Class III nobody 2015-05-12 13:14
  - FDA - Biowaiver Class IIIjag009 2015-05-14 16:31
    - FDA - Biowaiver Class III Helmut 2015-05-14 18:51
- OT: Reality vs Guidance luvblooms 2015-05-15 07:31
  - OT: Reality vs Guidance nobody 2015-05-15 10:34
    - OT: Reality vs Guidance luvblooms 2015-05-15 12:09
      - OT: Reality vs Guidance nobody 2015-05-15 16:40

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