Bioequivalence and Bioavailability Forum • BE study after Time Lag

BE study after Time Lag [Regulatives / Guidelines]

posted by Regaffairs – 2006-10-06 16:24 (7205 d 13:22 ago) – Posting: # 287
Views: 9,850

Dear Mr.Rotter,

Further to your quoted reply please find a suitable response

❝ You only may get a waiver for an in vivo BE study, if all of the conditions stated in the respective guideline (slightly different from country to country) are fulfilled, i.e., submitting dissolution similarity by an f₂ >50.

❝ Do you mean, you haven't submitted any in vitro data, and are now asked to show them, or your application for a biowaiver was rejected and the regulator now wants to see a biostudy?

We have claimed BCS waiver based on the applicable guideline and also have submitted the invitro dissolution data performed in the required regulatory media. The disso profile met the applicable requirement with more than 85% release in desired 30 minutes and F2 values > 50.

The application was reversed citing information on biostudy.

Thanks

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Edit: Original quotes restored. [Helmut]

Complete thread:

BE study after Time Lag Regaffairs 2006-10-06 10:38 [Regulatives / Guidelines]
- BE study after Time Lag H_Rotter 2006-10-06 13:21
  - BE study after Time LagRegaffairs 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