Bioequivalence and Bioavailability Forum

Dear All

I had a question regarding dispensing of IPs and dosing in a BA/BE study

Dispensing shall be carried out as per protocol for number of subjects planned to do dosing as per randomization schedule and dispensed IPs shall be stored in Stability chamber.

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.

1. What is the impact in respect to duration of days between dispensing and dosing.
   
2. 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).

Example

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


Now the question stated above is can we use the previously remained IPs after dispensing for 06 subjects planned to dose in period-01.


Can you please let me know the impact and guide what is the correct procedure

Regards
G.Balavivekanand

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Edit: Category changed. [Helmut]