Bioequivalence and Bioavailability Forum • Speculations

Speculations [BE/BA News]

posted by nobody – 2014-12-07 18:31 (3427 d 01:59 ago) – Posting: # 14002
Views: 19,257

What is the producer risk (rough estimate is sufficient) for a BE-study?

Just asking...

Sometimes statistics is against you, sometimes it's your friend. Not to speak of being able to read chromatograms, calibration curves etc.

I would start with an overview on all analytical runs performed, from validation to the final study samples. Dates, times, run time per chromatogram, run time per batch. Compare to times on print-outs of chromatograms. Start from the basics (if we talk of the analytical part, clinics is a differnt piece of cake).

If you can't get these data, reject the study overall.

My 5cent...

—
Kindest regards, nobody

Complete thread:

Bioequivalence in prime time TV news Dr_Dan 2014-12-05 08:42
- Bioequivalence in prime time TV news nobody 2014-12-05 08:51
  - Bioequivalence in prime time TV news Ohlbe 2014-12-05 14:10
    - Bioequivalence in prime time TV news nobody 2014-12-05 16:56
      - Bioequivalence in prime time TV news Helmut 2014-12-05 17:24
    - Bioequivalence in prime time TV news nobody 2015-01-23 17:08
- If you know German… Helmut 2014-12-05 13:27
  - If you know German… nobody 2014-12-05 14:20
    - Monitoring CROs Helmut 2014-12-05 17:49
      - Monitoring CROs nobody 2014-12-05 18:02
        
        Ethics? Helmut 2014-12-05 22:54
        
        Ethics? nobody 2014-12-06 14:23
      - Monitoring CROs ElMaestro 2014-12-06 22:10
        
        Monitoring CROs Helmut 2014-12-07 14:08
        
        Monitoring CROs nobody 2014-12-12 10:51
        
        Inspectors ≠ teachers (rather = examiners) Helmut 2014-12-12 14:41
- RCA ElMaestro 2014-12-07 01:06
  - Speculations Helmut 2014-12-07 14:41
    - Speculationsnobody 2014-12-07 17:31
    - Speculations ElMaestro 2014-12-07 20:20