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vivekanand ☆ India, 2012-11-24 15:51 (4551 d 16:41 ago) Posting: # 9581 Views: 6,555 |
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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.
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 Edit: Category changed. [Helmut] |
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Ohlbe ★★★ France, 2012-11-24 16:13 (4551 d 16:19 ago) @ vivekanand Posting: # 9584 Views: 5,551 |
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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:
Ohlbe — Regards Ohlbe |
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drgunasakaran1 ★★  2012-11-24 16:25 (4551 d 16:07 ago) @ vivekanand Posting: # 9585 Views: 5,566 |
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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. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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anky1212 ☆ India, 2013-05-30 15:37 (4364 d 17:55 ago) @ vivekanand Posting: # 10684 Views: 4,151 |
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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] |
Ing. Helmut Schütz