Bioequivalence and Bioavailability Forum • Choose and Pick in method validation

Choose and Pick in method validation [Bioanalytics]

posted by Ken Peh – Malaysia, 2013-11-24 05:41 (4203 d 16:03 ago) – Posting: # 11950
Views: 4,371

Dear All,

Appreciate feedback on the following questions:

In bioanalytical method validation, if we need N=5, is it acceptable to inject 8 and select 5 samples ? What if all 8 QC samples pass the precision and accuracy ? Should present results of 8 or 5 ?
For method validation, does it make sense to prepare samples until we get the numbers we want ? For example, inject 5, 1 fails, inject 1 again, the process continues until we get the results of 5.
If we follow EMEA method for bioanalysis, does it mean that we have to follow exactly ? There are some differences in opinions betwee FDA and EMEA in bioanalytical analysis. Any possibility inspector or regulatory agency asking us to carry out tests that are mentioned in FDA guideline but not in EMEA.

Thank you.

Best Regards,
Ken

Choose and Pick in method validationKen Peh 2013-11-24 04:41
- Choose and Pick in method validation Ohlbe 2013-11-24 22:45
  - Choose and Pick in method validation Ken Peh 2013-11-26 13:37
    - Choose and Pick in method validation Ohlbe 2013-11-26 18:45