Bioequivalence and Bioavailability Forum • the run passes = there is no problem?

the run passes = there is no problem? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2019-11-13 18:35 (1223 d 14:40 ago) – Posting: # 20799
Views: 3,551

Hi nobody,

❝ I like discussions along the line "problem -> solution". So: if the LLOQ is rock solid, the calibration function stable and the QCs don't indicate a problem, why should I take care of day-to-day variations in IS response too much?

Using the same kind of argumentation why would you worry about IS at all then? If the run passes why would IS responses in any way be a worry under any circumstance?
If the purpose of a car is to take you from A to B why would anyone care if it starts making sudden clonking noises?

—
Pass or fail!
ElMaestro

Complete thread:

IS response variations Ohlbe 2019-09-04 19:03 [Regulatives / Guidelines]
- IS response variations nobody 2019-09-06 16:21
- More on IS response variations Ohlbe 2019-11-12 11:32
  - More on IS response variations ElMaestro 2019-11-12 12:27
    - More on IS response variations Helmut 2019-11-12 13:24
      - More on IS response variations ElMaestro 2019-11-12 13:38
        
        More on IS response variations Helmut 2019-11-12 13:41
      - More on IS response variations Ohlbe 2019-11-12 13:56
        
        More on IS response variations ElMaestro 2019-11-12 16:25
        
        More on IS response variations Ohlbe 2019-11-12 18:14
        
        More on IS response variations ElMaestro 2019-11-12 18:39
        
        Not more on IS response variations Ohlbe 2019-11-13 00:06
        
        Not more on IS response variations nobody 2019-11-13 10:06
        
        the run passes = there is no problem?ElMaestro 2019-11-13 17:35
        
        the run passes = there is no problem? nobody 2019-11-13 19:17