Bioequivalence and Bioavailability Forum

Dear Ken,

❝ I. In bioanalytical method validation, if we need N=5, is it acceptable to inject 8 and select 5 samples ?

No. This would be considered cherry picking. If the unreported values fail: this may be interpreted as data manipulation.

❝ What if all 8 QC samples pass the precision and accuracy ? Should present results of 8 or 5 ?

If you analyse 8, report 8 whether they pass or fail.

❝ II. 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.

No. Again, this would be considered as cherry picking or even data manipulation.

❝ III. 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.

Follow the guideline of the region to which you intend to submit data. There are indeed some differences between the EMA, FDA, ANVISA etc. guidelines. If you want to have an SOP which covers all areas: for each parameter, use the most stringent requirement or recommendation.