Bioequivalence and Bioavailability Forum

Dear Mr Balavivekanand,

❝ In case of all the dispensed IPs are not dosed on dosing day due to insufficient volunteer for enrollment in to study as per protocol criteria (study divided in to groups) can the same remaining IPs form previous dispensed (stored under stability chamber) can be used for the dosing of next group.

Next Group?. Absolutely Not. You cannot dose the study subjects in Groups, if the same is not captured in the approved protocol.

❝ If IPs dispensed are not opened seal (IPs from blister pack with out opening seal-cut the IPs from blister and placed in Zip lock pouches and stored in Stability chamber till the dosing day).

If the current scenario is such that you dispensed the IPs one day prior to your planned dosing day. But, during checkin, sufficient number of volunteers didn't turned up for the study. In that case, the procedure for using the same dispensed IPs for the next dosing should be captured in your Standard Operating Procedure of Handling, Dispensing and Retention of the Investigational Products. You can mention in your SOP that the same dispensed IPs will be utilized for the consecutive day dosing, if the required number of subjects are not recruited.

❝ As per protocol 24 subjects need to be dosed accordingly in period-01,dispensing was done for 24 subjects as per randomization schedule, on the day of dosing it was realized that only 18 subjects enrolled, accordingly only 18 subjects were dosed.

It is a protocol violation. You cannot dose the subjects in groups if the dosing in groups is not mentioned in the approved protocol. Regulatory will not accept this approach.

❝ hence planned to conduct the study in groups stating that sufficient volunteers are not enrolled as per protocol criteria.

Will not accepted by the Regulatory Agencies. It is a protocol violation.