Bioequivalence and Bioavailability Forum • Reference scaled approach for HVD

Reference scaled approach for HVD [RSABE / ABEL]

posted by BE – 2009-03-19 13:30 (6308 d 12:56 ago) – Posting: # 3380
Views: 18,417

Dear HS,

❝ In the EU RSABE is not acceptable anyhow.

Please let me know when you state that RSABE approach is not accepted by EU, are you referring to any guideline. If such is the case, how you do recommend to conduct BE studies for HVD, especially to claim wider limits. I hope you agree that 2 way crossover is not the correct design the depict the innovator variability.

Best Regards,

BE

Edit: Quote restored. [Helmut]

Complete thread:

Reference scaled approach for HVD KR 2009-02-07 11:29
- Reference scaled approach for HVD Helmut 2009-02-07 15:58
  - Reference scaled approach for HVD d_labes 2009-02-09 11:26
    - Reference scaled approach for HVD ddubins 2009-03-12 03:34
      - Estimated knowledge d_labes 2009-03-12 14:55
        
        Estimated knowledge sdu 2010-01-26 21:21
        
        SABE issues d_labes 2010-01-27 14:00
  - Reference scaled approach for HVDBE 2009-03-19 12:30
- Reference scaled approach for HVD MGR 2009-04-01 07:59