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RegisterSubjects sleep schedule during study?? [Regulatives / Guidelines]
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
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
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Complete thread:
- Subjects sleep schedule during study??sachin_bhandurge 2013-09-27 06:45
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- Subjects sleep schedule during study?? drgunasakaran1 2013-09-27 18:35
- Subjects sleep schedule during study?? sachin_bhandurge 2013-10-01 11:11
- Subjects sleep schedule during study?? drgunasakaran1 2013-10-03 04:42
- Subjects sleep schedule during study?? sachin_bhandurge 2013-10-01 11:11
- Subjects sleep schedule during study?? drgunasakaran1 2013-09-27 18:35
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