Bioequivalence and Bioavailability Forum

Failed Fed study on Indapamide MR [Study Assessment]

posted by Clarc – Romania, 2013-11-20 08:28 (4595 d 04:56 ago) – Posting: # 11922
Views: 14,592

Dear All

Thank You for the replies

Dear El Maestro

❝ 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.

We have looked at the raw data, and the chromatograms too. Unfortunately the data tells me, that C_max for the test drug, is lower in 25 of 26 volunteers, and it's under 75% of the reference C_max, in about 20 volunteers.

To be more specific, and to complete the data: the AUC has made it, however the %AUCextra didn't.

Geomean Ratio (Test/Reference) = 1.38161

(around the ratio:[test form]/[ref form])=[1.1131,1.7149]

Clarc

—
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello

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 MR ElMaestro 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 MRClarc 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]