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Siswanto ☆ Indonesia, 2023-08-12 11:18 (45 d 20:46 ago) Posting: # 23693 Views: 774 |
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Dear all, Some subjects in our BE study of paracetamol suppositories was reported with zero data in reference drug or test drug. The BE lab did not have any idea for the reason and claimed that there were no mistakes in drug delivery method into subject. Could you please inform us any reason of the problem and how to prevent it? ![[image]](img/uploaded/image248.jpg) Thank you. Regards, Siswanto Edit: Category changed; see also this post #1. [Helmut] |
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dshah ★★ India/United Kingdom, 2023-08-14 18:15 (43 d 13:49 ago) @ Siswanto Posting: # 23694 Views: 621 |
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Hello Siswanto! It seems to be the issue with administration. Generally for oral drug- it is checked that dosage is consumed completely and is not spitted. So was the suppository administration monitored and confirmed that subject have not removed them? Regards, Divyen |
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Siswanto ☆ Indonesia, 2023-08-15 04:18 (43 d 03:45 ago) @ dshah Posting: # 23695 Views: 625 |
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Dear Divyen, Thank you for your reply. Single dose of the study drug (equivalent to one suppository), either test or reference according to the randomization code will be administered by Responsible Physician or Study Nurse to the subjects in a lateral position. Then, subjects will be asked to maintain in supine position for at least 4 hours and will be monitored by the study team. If there is any subject who needs to go to the toilet during the time range, subject needs to report to study team and study team will record the time and subject’s purpose (urinate/defecate). Regards, Siswanto |
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dshah ★★ India/United Kingdom, 2023-08-15 13:07 (42 d 18:57 ago) @ Siswanto Posting: # 23696 Views: 588 |
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Hi Siswanto! ❝ If there is any subject who needs to go to the toilet during the time range, subject needs to report to study team and study team will record the time and subject’s purpose (urinate/defecate). This may help you if the same subject had visited toilet immediately after administration. Hope study team ensure that subjects are complying with protocol after the toilet visit. Regards, Divyen |
Ing. Helmut Schütz