Bioequivalence and Bioavailability Forum • Pilot or Two-Stage

Pilot or Two-Stage [Design Issues]

posted by Ken Peh – Malaysia, 2013-02-18 19:19 (4879 d 07:26 ago) – Posting: # 10052
Views: 8,326

Dear Helmut,

❝ The 30years old paper does not help. After 5mg in five (!) subjects CV_total of C_max 93% and of AUC_t 51%… You need CV_intra from a cross-over study.

Understood. TQVM.

❝ IMHO you have two options:

❝ • Perform a pilot study which will (after drop-outs) > the minimum sample size in your regulation (Malaysia: 12). State in the protocol that if you are able to show BE already in the pilot the study will act as the pivotal study.

Do you mean if we use 20 subjects (>12) and able to show BE although the power is less than 80%, we can switch from pilot to pivotal ? How to justify to the regulatory agency on this ?

❝ • Perform a Two-Stage Sequential Design (see e.g., this presentation). Ask your authority whether such a design is acceptable. The Malaysian GL from 2000 of course does not cover such a design.

Yes, the new ASEAN guideline addresses this. Thank you for the presentation. Will digest the information.

Highly appreciate your kind assistance.

Best Regards,
Ken

Complete thread:

Trifluoperazine Ken Peh 2013-02-16 16:26 [Design Issues]
- Trifluoperazine drgunasakaran1 2013-02-17 08:53
  - Trifluoperazine Ken Peh 2013-02-18 07:28
    - Pilot or Two-Stage Helmut 2013-02-18 13:53
      - Pilot or Two-StageKen Peh 2013-02-18 18:19
        
        Pilot or Two-Stage Helmut 2013-02-19 13:37
        
        Pilot or Two-Stage Ken Peh 2013-02-20 03:34
        
        Post hoc power & other things… Helmut 2013-02-20 20:11
        
        Post hoc power & other things… Ken Peh 2013-02-22 08:17
        
        Post hoc power & other things… Helmut 2013-02-22 14:15
        
        Post hoc power & other things… Ken Peh 2013-02-24 09:08
        
        estimation ≠ calculation Helmut 2013-02-24 17:09