Bioequivalence and Bioavailability Forum • Reporting of plasma concentration data etc

Reporting of plasma concentration data etc [Bioanalytics]

posted by jag009 – NJ, 2014-09-19 00:22 (4302 d 12:11 ago) – Posting: # 13537
Views: 14,932

Hi Ohlbe,

Okay.. So what if the dose given is 20mg? I mean we don't know the decimals right? The reason I ask is what if the concentration data shows high variability and you see values such as 0.0543, 1.1253, 20.3521? So you would go with 0.0543, 1.13, 20.4? But yet with the 90% CI rule the goal post is 80.00 - 125.00 and 2 decimal places needed to be reported (?)

❝ I would report the concentrations with 3 significant digits (or more probably 4, actually) but I would calculate AUC with non-rounded concentrations. You can put a note in the report explaining that the concentrations in the tables are rounded but that PK parameters were calculated with full precision to avoid questions from reviewers.

What would you do with Cmax if the individual values range from 10.xxx to 100.xxx?

Thanks
John

Complete thread:

Reporting of plasma concentration data etc jag009 2014-09-18 21:32
- Reporting of plasma concentration data etc Ohlbe 2014-09-18 21:50
  - Reporting of plasma concentration data etcjag009 2014-09-18 22:22
    - Reporting of plasma concentration data etc Ohlbe 2014-09-19 12:26
  - Reporting of plasma concentration data etc d_labes 2014-09-19 08:46
    - Reporting of plasma concentration data etc nobody 2014-09-19 10:31
      - Reporting of plasma concentration data etc jag009 2014-09-19 15:26
        
        Reporting of plasma concentration data etc nobody 2014-09-19 16:01
        
        Reporting of plasma concentration data etc jag009 2014-09-26 16:29
- Reporting of plasma concentration data etc SDavis 2014-09-25 15:10
  - Reporting of plasma concentration data etc Helmut 2014-09-25 16:11
  - Reporting of plasma concentration data etc jag009 2014-09-26 16:22
    - Reporting of plasma concentration data etc Ohlbe 2014-09-28 13:53
  - Reporting of plasma concentration data etc ElMaestro 2014-09-28 15:07
    - SAS vs. PHX/WNL Helmut 2014-09-28 17:21
- Numbers should reflect the precision of the instrumentation Helmut 2014-09-28 19:34