Bioequivalence and Bioavailability Forum

Dear Ohlbe and all!

I agree with all points Ohlbe made. I think Mr. Statistician is a little bit overreacting. The decision whether a protocol deviation is minor or major is not his business. Imaging a situation where 500 mg paracetamol are allowed per period in order to treat headaches and the investigor decided to give a second dose. Biostatistics are a supportive technique, decisions always have to be based on clinical grounds.

❝ Whatever you decide: take the decision before you analyse the samples from

❝ this subject.

I guess by 'analyse' you mean the statistical analysis? I would always perform bioanalyses - even if the decision was against keeping the subject in the evaluation. What if regulators want to see an evaluation including the subject two years later - when biosamples went already to the garbage bin?