Bioequivalence and Bioavailability Forum • Open your mouth and forcefully spit the water out

Open your mouth and forcefully spit the water out [Two-Stage / GS Designs]

posted by Shuanghe – Spain, 2013-10-22 11:03 (4262 d 10:21 ago) – Posting: # 11724
Views: 26,026

Hi Helmut,

❝ Have you asked them which methods would be acceptable according to their impeccable wisdom instead? They should enlighten us simpletons.

No, I contact them indirectly (through a colleague of mine).

❝ Yes. For some recent (this year’s) experiences see slide 45 of this presentation. Method C [sic] accepted by Germany (RMS) and CMSs Austria, Denmark, Sweden, and The Netherlands. Spain asked for an all-fixed effects analysis (subjects within sequence were random in the original analysis).

Seems the same one as I saw in Budapest in your talk this May. This is actually the very reason I wanted to ask the same question again since you have presented some studies already... Well, now we know how it goes...

❝ ... I hope someone has the balls and goes for a referral. If a GL (not a law anyway) states 2×2=5 I would wholeheartedly ignore it for sure.

If that's my own company, I probably will. :lol3:

Unfortunately I have boss to answer to...

❝ ... A paper “On the Statistical Model of the Two-Stage Design in Bioequivalence Assessment” by Karalis/Macheras is currently under review (J Pharm Pharmacol). ...

Interesting. Thanks. I'll get it when it is published.

—
All the best,
Shuanghe

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 world Helmut 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 outShuanghe 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