Bioequivalence and Bioavailability Forum

Dear YT

❝ 1. Is this a major deviation in GCP point of view?

❝ 2. The study staffs knew that this is a protocol deviation. Are we make

❝ wrong decision to let this volunteer continued in second period?

Indeed! If your study staff knew that this is a protocol deviation then what is the point to continue with that particular subject. Any deviation in the protocol is a deviation and that is an abstract fact. so you shouldn't try to hide or modify the fact.

❝ The clinical persons replied : "Hey!! both of you were not understand the

❝ clinical point of view. Just laying down is only minor deviation that

❝ may not effect absorption pattern. So it is OK to keep him."

Mostly with the ER/XR formulations this is a case that subject should stay upright for some time and movement should be restricted after administration of dosage because that can affect the gastric motility and gastric residence time of the dosage unit.

❝ The QA : "If you think there are little effect on absorption, why you

❝ write it down in the protocol............."

The outlier criterion should be pre-defined in the protocol and has to be observed scrupulously.

Regards
Kaushalesh