Bioequivalence and Bioavailability Forum • Zero concentrations – all samples

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

posted by ElMaestro – Denmark, 2014-04-05 22:17 (4465 d 16:16 ago) – Posting: # 12776
Views: 16,599

Hi Pash413,

❝ We are concerned about the data loss of subjects having non-zero PK parameters (Cmax and AUC) in at-least 2 or 3 periods, just because mathematically log (0) is not estimable.

❝

❝ 1. Is there any statistical methodology to include data of subjects who have non-zero PK parameters (Cmax and AUC) in at least 3 periods to prevent such huge data loss :confused:

Come on, with these 45%+ figures something has gone seriously wrong in the planning or conduct of your study; your data do not shed light onto the comparability of the two products. This isn't the time to fiddle and tweak with BLQ data or do imputation or clever transforms - rather it is the time to think hard and find out what went wrong and how to prevent recurrence.

❝ [Note: LLOQ was sufficiently low to capture the PK profile]

Errr..... so then the subjects didn't take the meds? Did the staff/PI check with a tongue spatula?

—
Pass or fail!
ElMaestro

Complete thread:

Zero concentrations – all samples – full replicate pash413 2014-04-05 14:56
- Zero concentrations – all samples – full replicateElMaestro 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 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