Bioequivalence and Bioavailability Forum • Two stage BE design

Two stage BE design — cold water thrown on our head [Two-Stage / GS Designs]

posted by Shuanghe – Spain, 2013-10-18 12:05 (4210 d 06:29 ago) – Posting: # 11692
Views: 25,841

Hi guys,

❝ I think method B is the current EU winner due to alpha=0.0294 being used at both steps.

Well, if the feedback I just got is official, you would be wrong — All methods with prefix "Potvin" are losers, in EMA region I mean.

Here's some input from certain agency with regard to 2-stage design I posted a year ago that the methods are "... not valid in Europe".

and a few weeks back we asked again for one of our projects, given the fact that more studies were presented with Potvin's method. Helmut alone got quite a few. :cool:

Below are loose translations:

Q: "..., we'd like to ask about the current status of 2-stage design BE study, ... if the BE protocol with Potvin's Method C is acceptable now ..."

A: "Potvin's methods are not acceptable in EMA."

:confused:

so, first question, how could it be? Have some of you guy's dossiers with Potvin's method(s) been approved/accepted (no deficient letter, rejection letter etc)?

Secondly, it got me double check the guideline. I always had the impression that method B is practically mentioned in the guide. Not quite. :no:

There's no mention of interim power analysis in the BE guide while method B... you know. So I guess the power analysis is probably the "evil" here causing all the fuss...

There's rumour that some working party is currently discussing this topic. Anyone has any insight?

—
All the best,
Shuanghe

Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12 [Two-Stage / GS Designs]
- Two stage BE design ElMaestro 2013-08-06 10:05
- Two stage BE design Helmut 2013-08-06 15:31
  - Two stage BE design Mahesh 2013-08-07 06:51
    - Two stage BE design kumarnaidu 2013-10-17 15:08
      - Two stage BE design ElMaestro 2013-10-17 17:28
        
        Two stage BE design kumarnaidu 2013-10-18 05:59
        
        EMA vs. rest of the world Helmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our headShuanghe 2013-10-18 10:05
        
        Open your mouth and forcefully spit the water out Helmut 2013-10-18 13:29
        
        Change in statistical design kumarnaidu 2013-10-19 07:52
        
        Bad idea Helmut 2013-10-19 15:04
        
        Bad idea kumarnaidu 2013-10-21 06:01
        
        Change to Method B? Helmut 2013-10-21 14:51
        
        Change to Method B? kumarnaidu 2013-10-22 06:15
        
        Simulations Helmut 2013-10-22 13:20
        
        Open your mouth and forcefully spit the water out Shuanghe 2013-10-22 09:03
        
        Reach for the stars Helmut 2013-10-22 13:05
        
        Alpha inflation in two stage design kumarnaidu 2013-12-04 13:43
        
        Deficiency letters Helmut 2013-12-04 14:50
        
        Deficiency letters kumarnaidu 2013-12-05 06:18
        
        Simulations Helmut 2013-12-05 15:51
        
        Simulations kumarnaidu 2013-12-05 16:07
        
        Simulations Helmut 2013-12-05 16:55
        
        Simulations kumarnaidu 2013-12-06 06:07
        
        Ejaculatio praecox Helmut 2013-12-06 14:30
        
        Ejaculatio praecox kumarnaidu 2013-12-06 15:13
        
        All effects fixed Helmut 2013-12-06 15:31
        
        All effects fixed kumarnaidu 2013-12-09 07:33
        
        EMA… Helmut 2013-12-09 12:45