Bioequivalence and Bioavailability Forum • Reporting of plasma concentration data etc

Reporting of plasma concentration data etc [Bioanalytics]

posted by nobody – 2014-09-19 18:01 (4300 d 09:31 ago) – Posting: # 13542
Views: 14,784

❝ I just don't like the inconsistency of the labs. Some go with 3 decimal places, some go with 3 significant figures.

Isn't there anything in the guidances? ;-)

Start a controlled correspondence with the FDA?

The "4 digits" approach is reasonable, ask your lab in the analytical study plan to provide the data in the format you like, or are you the poor one who get's the data after all is finished? :-(

PS: Found it...

"A presentation of numeric data that is consistent with instrumental capabilities and acceptance criteria. The method should indicate what format to use to report results (e.g., percentage label claim, weight/weight, and weight/volume etc.) with the specific number of significant figures needed.

The American Society for Testing and Materials (ASTM)E29 describes a standard
practice for using significant digits in test data to determine conformance with specifications."

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf

In the bioanalytical method validation guidance there is nothing on significant digits...

—
Kindest regards, nobody

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 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 etcnobody 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