Bioequivalence and Bioavailability Forum

Failed Fed study on Indapamide MR [Study Assessment]

posted by ElMaestro – Denmark, 2013-11-19 16:56 (4600 d 16:15 ago) – Posting: # 11915
Views: 14,635

Hello Clarc,

I get a 26% CV for AUC, which is a bit higher than the observed CV for Cmax. Although this may happen, it is rarely the actual case and for that reason I raise an eyebrow. So I can't conclude anything, but I would investigate this if I were you; in particular I'd look at the raw data from the bioanalysis, esp. chromatograms.
In the past when I have triggered audits because of this phenomenon we have always been able to identify an 'issue' although in the grand scheme of things it has not been that many studies, and none of them were MR SODFs if I recall correctly.

—
Pass or fail!
ElMaestro

Complete thread:

Failed Fed study on Indapamide MR Clarc 2013-11-19 11:04
- Failed Fed study on Indapamide MR Dr_Dan 2013-11-19 14:31
- Failed Fed study on Indapamide MRElMaestro 2013-11-19 15:56
  - CV from CI Helmut 2013-11-19 16:42
    - CV from CI ElMaestro 2013-11-19 16:59
      - Misprint gremlin Helmut 2013-11-19 17:05
  - Failed Fed study on Indapamide MR Clarc 2013-11-20 07:28
- Failed Fed study on Indapamide MR jag009 2013-11-19 19:45
  - Failed Fed study on Indapamide MR Clarc 2013-11-20 07:36
    - Failed Fed study on Indapamide MR luvblooms 2013-11-20 08:51
      - Failed Fed study on Indapamide MR Clarc 2013-11-20 10:59
        
        Failed Fed study on Indapamide MR jag009 2013-11-20 17:30
        Failed Fed study on Indapamide MR luvblooms 2013-11-21 06:00
        
        Failed Fed study on Indapamide MR Clarc 2013-11-21 07:11

Failed Fed study on Indapamide MR [Study As­sess­ment]

Complete thread:

Failed Fed study on Indapamide MR [Study Assessment]