Bioequivalence and Bioavailability Forum

Regulations ≠ Science [Study Assessment]

posted by Helmut – Vienna, Austria, 2017-05-19 16:07 (3319 d 11:27 ago) – Posting: # 17373
Views: 9,862

Hi Averroes,

❝ […] the GMR constrant is there for political reasons more than for scienfic or statistical reasons.

Exactly. Suggested by Les Benet.

❝ Do you think we could still have an opportunity with European regulatory agencies?

I’m always happy to challenge regulatory practices. But in this case the chances to succeed are close to nil. IMHO, even trying is a complete waste of time. Alfredo will never, ever buy it.

—
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:

Study Results VSL 2015-04-20 21:46
- Study Results ElMaestro 2015-04-20 23:47
  - upper CL < PE Helmut 2015-04-21 00:39
- PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 00:24
  - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-21 16:49
    - PE restriction for HVDs/HVDPs; testing effects Helmut 2015-04-21 17:12
      - PE restriction for HVDs/HVDPs; testing effects jag009 2015-04-22 15:47
        
        PE restriction for HVDs/HVDPs Helmut 2015-04-22 16:41
  - GMR outside the limits when using ABEL Averroes 2017-05-19 11:53
    - Regulations ≠ ScienceHelmut 2017-05-19 14:07
      - Regulations ≠ Science Averroes 2017-05-22 20:51

Regulations ≠ Science [Study As­sess­ment]

Complete thread:

Regulations ≠ Science [Study Assessment]