Bioequivalence and Bioavailability Forum • EMA vs. rest of the world

EMA vs. rest of the world [Two-Stage / GS Designs]

posted by Helmut – Vienna, Austria, 2013-10-18 16:42 (4266 d 05:52 ago) – Posting: # 11700
Views: 26,354

Hi Kumar,

❝ That means if I am adopting method C EU regulators will not accept or may raise serious questions on the design.

Yes, that will be possible. See the case studies in this presentation (slides 43–45). EMA* obviously believes to be very clever – which awaits proof.

❝ In Canadian guideline they have recommended method C.

Correct – following recommendations of the authors. Method C is also recommended by the FDA. Not surprising, since this method was developed by the the non-profit organization PQRI (members: FDA/CDER, Health Canada, USP, AAPS, CHPA, PhRMA,…). FDA’s Donald Schuirmann is one of the authors.

❝ Is there any recommendations for two stage design in EU guidelines like Canada.

Not that I recall. When it comes to two-stage designs the GL is crap. See also Shuanghe’s exeriences and my reply.

To be correct some members states’ authorities. I had never [sic] any problems with Germany’s BfArM, for example.

—
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Helmut Schütz

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Science Quotes

Complete thread:

Acceptance by FDA/CDER Mahesh 2013-08-06 06:12
- 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 worldHelmut 2013-10-18 14:42
        
        Two stage BE design — cold water thrown on our head Shuanghe 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