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sachin_bhandurge ☆ India, 2013-09-27 08:45 (4652 d 21:22 ago) Posting: # 11567 Views: 3,393 |
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Dear All, I want to conduct steady state study for Russia, there will be 5 days continuous dosing to the subjects at the interval of 8 hrs for 3 times i.e at 0 hr (8.00 am), 8 hr (4.00 pm) and 16 hr (12.00 pm) followed by vital at around 17 hr (1.00 am), next day morning subjects have to wake-up for vitals and predose Blood sampling. In all these activities subjects will sleep roughly for only 5hrs. On the whole My question is that is their any guideline? which talks about that subjects should take sleep for particular period. Kindly suggest proper justification if u can give me. THANK U!!! Regard's SACHIN — PREM |
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drgunasakaran1 ★★  2013-09-27 20:35 (4652 d 09:32 ago) @ sachin_bhandurge Posting: # 11571 Views: 2,693 |
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Dear Mr Sachin, ❝ On the whole My question is that is their any guideline? which talks about that subjects should take sleep for particular period. None of the Drug Regulatory guidelines talks about the minimum sleep duration required to be provided for study subjects. — 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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sachin_bhandurge ☆ India, 2013-10-01 13:11 (4648 d 16:56 ago) @ drgunasakaran1 Posting: # 11579 Views: 2,507 |
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Dear Dr.S.Gunasakaran, Thank you very much!! but if we think from ethical point of view we should have something which talks about sleep and somewhere less sleep for continuous 5 days and blood withdrawn collectively it may affect on the body of volunteer, bt at the same time, I need to keep this schedule which is the requirement of the study. In future if any query raised how we can justify. Regard's SACHIN Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] — PREM |
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drgunasakaran1 ★★ 2013-10-03 06:42 (4646 d 23:26 ago) @ sachin_bhandurge Posting: # 11591 Views: 2,511 |
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Dear Mr Sachin, ❝ but if we think from ethical point of view we should have something which talks about sleep and somewhere less sleep for continuous 5 days and blood withdrawn collectively it may affect on the body of volunteer, bt at the same time, I need to keep this schedule which is the requirement of the study. You can consider the option of maintaining the postural restriction in the supine position after dosing to avoid any ethical issues. — 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 |
Ing. Helmut Schütz