Srinetram ☆ India, 2014-07-21 10:32 (3538 d 13:18 ago) Posting: # 13280 Views: 3,156 |
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Dear All A very warm Good Morning We are planning to do a study for US submission and we want to put a condition of 24hr pre-dose housing for the same. Our regulatory team wantsto put a justification for the same in the protocol. And I am totally confused how to write it? Would this below kind of write up will suffice the need "Subjects will be housed 24 hr pre-dose for conditioning and required to fast overnight for at least 10 hours until their scheduled dosing time. Fasting will be continued four hours post-dose (Blah.... Blah). " Or there is any alternate way of writing the same? Thanks in advance. Regards Srinetram |
Dr_Dan ★★ Germany, 2014-07-22 10:06 (3537 d 13:44 ago) @ Srinetram Posting: # 13287 Views: 2,124 |
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Dear Srinetram The question is not how to include a 24 h predose housing but why should the subjects be housed for such a period since this is an additional burden for them? If you have a reasonable answer then it should be no problem to include the prolonged pre-dose housing in the protocol. Safety is always a strong argument. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
kvgreddy06 ☆ India, 2014-07-23 20:12 (3536 d 03:38 ago) @ Dr_Dan Posting: # 13302 Views: 2,142 |
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Dear ALL We can write like, All subjects will be housed in the clinical study facility at least 24.00 hours before administration of the IP and will continue to remain in the clinical study facility for at least 24.00 hours after administration of the IP in each study period. pre dose In house will be usefull in few BE studies, we have experience in this case. Kind regards venu |