Bioequivalence and Bioavailability Forum • Zero concentrations – all samples

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

posted by pash413 – India, 2014-04-07 11:30 (4055 d 03:01 ago) – Posting: # 12782
Views: 13,540

Hello HS

❝ I don’t think that you can derive a meaningful comparison from your data.

Agreed to your point.

But the reason behind us being curious to use partial data (subjects with non-zero Cmax/AUC in at-least 2/3 periods) is because one of the firm has used the method of Imputation for same molecule (MESALAMINE) which was well accepted by FDA. (Delzicol Clinical Pharmacology and Bio-pharmaceutics review link provided in my above posts).

We would like to understand the applicability and scope of such statistical methodology.

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 replicatepash413 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 replicate luvblooms 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