Bioequivalence and Bioavailability Forum • EMA oracle

EMA oracle [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2015-01-27 17:27 (3760 d 01:48 ago) – Posting: # 14322
Views: 25,343

Dear all,

today (at the XII Congreso de la Sociedad Española de Farmacia Industrial y Galénica in Barcelona) I had a strange encounter with Alfredo García-Arieta.

I asked him whether the EMA is aware that by applying their ABEL-method for HVD(P)s the type I error might be substantially inflated.* The answer was no and that the two Lászlós showed inflation of up to 7% only for FDA’s method – which is not correct (already in their paper of 2009). Next I asked whether it would be acceptable to use a method different from the guideline (e.g., iteratively adjusted α). Answer: “No; you have to comply with what is stated in the guideline.” I couldn’t believe it and asked for confirmation whether one has to use a method which might inflate the patient’s risk to 20%. The answer was “Yes. If you want you can change the guideline.”
Was too strong stuff for my poor soul. A regulator who values a lousy piece of paper more than the health of patients. I had to leave the lecture hall.

Later on he confirmed that Potvin’s methods are not acceptable because the intermediate power estimation is not stated in the guideline.
Lesson learned: Whatever might be published by well renowned authors in peer-reviewed journals counts (by far) less than the personal opinion of the almighty oracle speaking ex cathedra.

Wonnemann M, Frömke C, Koch A. Inflation of the Type I Error: Investigations on Regulatory Recommendations for Bioequivalence of Highly Variable Drugs. Pharm Res. 2015;32(1):135–43. doi 10.1007/s11095-014-1450-z.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

EMA oracleHelmut 2015-01-27 16:27 [RSABE / ABEL]
- EMA oracle nobody 2015-01-27 17:07
- Personal opinion ElMaestro 2015-01-27 17:56
- EMA oracle d_labes 2015-01-27 19:44
  - EMA oracle nobody 2015-01-28 09:04
    - EMA oracle ElMaestro 2015-01-28 13:11
- Response from Alfredo García-Arieta Helmut 2015-01-30 10:55
  - Response from Alfredo García-Arieta nobody 2015-01-30 14:55
    - Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 01:35
      - Wonnemann’s Figure 4 on steroids nobody 2015-02-01 11:18
        
        Wonnemann’s Figure 4 on steroids Helmut 2015-02-01 14:49
      - General remarks ElMaestro 2015-02-01 18:43
        
        General remarks nobody 2015-02-01 22:04
        General remarks Helmut 2015-02-02 00:48
        
        General remarks nobody 2015-02-02 08:09
        
        General remarks Helmut 2015-02-02 14:06
        
        TIE: questions mittyri 2015-02-03 12:44
        
        TIE: questions Helmut 2015-02-03 13:24
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 12:02
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 12:22
        
        FDA RSABE & alpha inflation d_labes 2015-02-03 13:07
        
        FDA RSABE & alpha inflation Helmut 2015-02-03 13:41
- New Zealand nobody 2015-01-31 11:25
  - New Zealand Helmut 2015-02-01 16:08
    - New Zealand nobody 2015-02-01 22:08
      - New Zealand Helmut 2015-02-01 23:54
        
        New Zealand nobody 2015-02-02 08:07