Bioequivalence and Bioavailability Forum • Potency correction

Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 12:10 (2571 d 10:53 ago) – Posting: # 18957
Views: 6,572

Dear El Maestro,

❝ I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.

❝ 90% CI is 77-108 [...]

Now let's take the opposite example: 90% CI is 81-110. Contents: 103% for T, 97% for R. Baseline correction and assay results pre-specified in the protocol. Outcome after correction: the study fails.

—
Regards
Ohlbe

Complete thread:

Potency correction - I still don't get it ElMaestro 2018-06-23 10:14
- Potency correction - Only in exceptional cases d_labes 2018-06-23 18:04
  - Potency correction - Only in exceptional cases ElMaestro 2018-06-23 19:55
    - Potency correction: Rather why than when Helmut 2018-06-24 00:55
      - Potency correction: Rather why than when ElMaestro 2018-06-25 10:22
        
        Potency correction: Upper limit? Helmut 2018-06-25 15:34
    - Potency correction - Example d_labes 2018-06-24 14:40
- Potency correction - EAUnion opinion mittyri 2018-06-23 22:53
- Potency correction - exampleOhlbe 2018-06-25 10:10
- Let me answer my own question ElMaestro 2018-06-25 18:24
  - Someone, somebody - slightly OT d_labes 2018-06-25 19:49