Bioequivalence and Bioavailability Forum • Reporting of plasma concentration data etc

Reporting of plasma concentration data etc [Bioanalytics]

posted by Ohlbe – France, 2014-09-19 14:26 (3901 d 12:24 ago) – Posting: # 13540
Views: 13,005

Hi John,

❝ Okay.. So what if the dose given is 20mg? I mean we don't know the decimals right?

True, but the 20 mg is not used for calculations of PK parameters or bioequivalence.

❝ 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?

Yes. Or actually go for 4 digits if possible.

❝ But yet with the 90% CI rule the goal post is 80.00 - 125.00 and 2 decimal places needed to be reported (?)

Yes... Which is indeed in contradiction with what I wrote previously (5 digits for 125.00, more than the 4 I use for concentrations). In any case it is a bit artificial here: the rounding of 90 % CI to two decimals is just for reporting, but Helmut would say that the exact value should be used to conclude on bioequivalence...

I usually use full precision for any calculation, and only round at the end. If you round each value before the calculations, inaccuracies will add on.

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

I would report 10.xx to 100.x...

—
Regards
Ohlbe

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 etc jag009 2014-09-18 22:22
    - Reporting of plasma concentration data etcOhlbe 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