Bioequivalence and Bioavailability Forum • Zero concentrations – all samples

Zero concentrations – all samples – full replicate [RSABE / ABEL]

posted by luvblooms – India, 2014-04-07 13:50 (4055 d 04:59 ago) – Posting: # 12784
Views: 13,591

Dear Pash

❝ We have thought about all possibilities as mentioned above, but there is no evidence for noncompliance in the study.

❝

❝ However the formulation (Mesalamine DR tablet) itself has such property. please refer Literature Reference.

I too am talking about the Meslamine DR tablet formulations and my experience with it. And what I told you were from those learning only. You need to control your clinical part and design your study appropriately and belive me this value will decrease to a level of 10-15% from 45-50%.

❝ Our main concern is how to handle such incomplete data statistically in scaled average (full/partial replicate) design study :confused:

IMHO, if your only concern is the data handling and stats, best option is to go for Controlled corresponence with FDA.

—
~A happy Soul~

Complete thread:

Zero concentrations – all samples – full replicate pash413 2014-04-05 14:56
- Zero concentrations – all samples – full replicate ElMaestro 2014-04-05 20:17
- Zero concentrations – all samples – full replicate luvblooms 2014-04-07 07:47
  - serious risk to public health Dr_Dan 2014-04-07 08:35
  - Zero concentrations – all samples – full replicate pash413 2014-04-07 08:37
    - Zero concentrations – all samples – full replicate Helmut 2014-04-07 09:01
      - Zero concentrations – all samples – full replicate pash413 2014-04-07 09:30
        
        Imputation and BE/TE ElMaestro 2014-04-07 12:14
      - Zero concentrations – all samples – full replicate nobody 2014-04-07 09:31
    - Zero concentrations – all samples – full replicateluvblooms 2014-04-07 11:50
      - Zero concentrations – all samples – full replicate Mahesh M 2014-04-07 12:23
      - Zero concentrations – all samples – full replicate jag009 2014-04-07 16:18
    - Zero concentrations – all samples – full replicate jag009 2014-04-07 15:29
- Stability ? Ohlbe 2014-04-07 18:23
  - Stability ? Helmut 2014-04-07 19:39
    - Stability ? pash413 2014-04-09 13:00
      - Stability ? Mahesh M 2014-04-09 14:51
      - Stability ? Ohlbe 2014-04-09 16:31