Bioequivalence and Bioavailability Forum • Biowaiver rejected...

Biowaiver rejected... [Regulatives / Guidelines]

posted by H_Rotter – Germany, 2006-10-10 16:19 (7201 d 09:32 ago) – Posting: # 301
Views: 9,824

Hi Ahmed,

you summarized the important points, but since (as Regaiffairs has already stated in his/her previous post:

❝ We have claimed BCS waiver based on the applicable guideline [...]

BTW, which country's MOH (Ministry of Health?) are you talking about - guidelines differ...

Regards,
Hermann

Complete thread:

BE study after Time Lag Regaffairs 2006-10-06 10:38
- BE study after Time Lag H_Rotter 2006-10-06 13:21
  - BE study after Time Lag Regaffairs 2006-10-06 14:24
    - Biowaiver rejected... H_Rotter 2006-10-06 15:07
- Biowaiver rejected... Ahmed meeran 2006-10-10 13:49
  - Biowaiver rejected...H_Rotter 2006-10-10 14:19
    - Biowaiver rejected... Ahmed meeran 2006-10-10 14:41
      - Biowaiver rejected... H_Rotter 2006-10-10 15:02

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