dispensing of IPs and dosing [Study Per­for­mance]

posted by anky1212 – India, 2013-05-30 15:37 (4771 d 01:27 ago) – Posting: # 10684
Views: 5,388

Dear Mr. Vivekanand,

❝ 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".


In this case, first of all you have to take sponsor approval stating that 18 subject had checked in instead of 24 subjects. You can dose 18 subjects only after seeking sponsor approval. Also, you can not divide study in a group if it is not specified in the protocol.

❝ 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).


Dispensing and dosing duration should kept as minimum as possible to maintain IP stability.
Since, IPs are in blister pack, you can use the same for dosing of another subjects even after dispensing.

Regards,
anky1212

Edit: Standard quotes restored. [Helmut]

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