Bioequivalence and Bioavailability Forum • Not more on IS response variations

Not more on IS response variations [Regulatives / Guidelines]

posted by nobody – 2019-11-13 11:06 (1616 d 13:46 ago) – Posting: # 20797
Views: 4,019

Not a key opinion leader in this field, but:

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?

If have had cases where different lab people (in the good old days of liquid-liquid extraction, though...) could produce different IS response with absolute same equipment, solutions, protocols to follow. Why bother to much, as long the quality of the method/validation covers that?

—
Kindest regards, nobody

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 variationsnobody 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