Bioequivalence and Bioavailability Forum

Dear Balavivekanand

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

If the IPs were provided in blisters, and were dispensed still in blister (just cutting around each tablet with scissors, making sure no blister gets open in the process): no problem, you can still use the remaining dispensed IPs.

If they were not in blisters, or if you opened the blisters: the problem is that you have no stability data in the containers you are using. If you keep your dispensed IPs in closed containers under strictly controlled temperature and humidity conditions it will have no consequence for most IPs; it may be problematic for more sensitive molecules. Two options:

• either contact the sponsor and discuss this issue with them. They may have stability data under various conditions with various types of containers;
  
• just re-dispense for the remaining subjects.

Regards
Ohlbe