Bioequivalence and Bioavailability Forum • Pilot or Two-Stage

Pilot or Two-Stage [Design Issues]

posted by Ken Peh – Malaysia, 2013-02-20 04:34 (4869 d 16:20 ago) – Posting: # 10072
Views: 7,918

Dear Helmut,

❝ The sample size should be as large that after excluding drop-outs you have still 12 evaluable subjects. In how many you actually start depends on the AE-profile of the drug. I would consider it unethical to perform a pivotal study when you have already shown BE in the pilot. Of course your intention to do so has to be stated in the protocol.

Do you mean even we can not achieve the power (>80%) as long as BE is proven ??? Am I correct?

❝ Do you have a reference?

I do not have newer version. Nevertheless, the 2013 ASEAN Guideline on BA/BE will be out soon.

❝ If one expects a deviation of ±20% (c) the samples size has to be infinity even for a CV of zero. ;-) Should read “ie ±5%”.

I am sorry. Could you please kindly elaborate the last sentence."If one expects a deviation of ±20%, the samples size has to be infinity even for a CV of zero. Should read “ie ±5%".

Regards,
Ken

Complete thread:

Trifluoperazine Ken Peh 2013-02-16 16:26
- 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-Stage Ken Peh 2013-02-18 18:19
        
        Pilot or Two-Stage Helmut 2013-02-19 13:37
        
        Pilot or Two-StageKen 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