Bioequivalence and Bioavailability Forum

Dear Shankaranarayanan!

❝ As you mentioned in this post "were the concentrations higher than 'normal'" should be excluded, subjected with the reason. I think you mean to say the subject is an outlier. Which should be dropped based on pk/statistical analysis.

I did not mean that. At least according to European guidelines biosamples of a subject who dropped out from a study (for any reason), must be analysed and accounted for. Just imagine a situation where a subject withdraw consent continuing the study because of adverse events (e.g., heavy headaches). If you administered a modified release formulation which might be subjected to a sudden release of drug, it's quite interesting to see such a relationship.

This has nothing to do with exclusion of a subject.