Bioequivalence and Bioavailability Forum

Dear HS,

❝ 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.

Ummmm.., I don't know it is my business, or not? I just give my opinion to everyone in meeting whether please caution about bias. Previously, one person in the meeting answered QA's question about that subject "why don't we drop him out after bio analysis? when his plasma concentration is irregular from another period because that shows laying down effect to plasma concentration". I had realized already that I don't have right to judge which deviation is minor or major but in this case I have to give opinion. I don't concern what is protocol deviation because that is QA duty. I give opinion because I only don't want to let it go without discussion concerning bias. But my opinion support QA.

Regards,
Boonchai L. (Mr.Statistician)