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biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah – India/United Kingdom, 2022-01-24 11:01 (123 d 06:30 ago) – Posting: # 22750
Views: 905

Hi John!
Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.
Regards,
Dshah

Complete thread:

biowaiver for higher strength jag009 2022-01-24 07:48 [Regulatives / Guidelines]
- biowaiver for higher strengthdshah 2022-01-24 11:01
  - biowaiver for higher strength jag009 2022-01-24 15:09
    - biowaiver for higher strength dshah 2022-01-24 20:18
    - biowaiver for higher strength dshah 2022-02-03 19:07
- Linearity Ohlbe 2022-01-24 12:16
  - Linearity jag009 2022-01-24 15:06
- biowaiver for higher strength wienui 2022-02-01 09:12

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