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cr.maroj ☆ UK, 2013-10-01 15:47 (4240 d 13:08 ago) Posting: # 11580 Views: 5,505 |
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Hi, Could you please let me know your opinion, is dosing in a room separate from the clinic permissible? or dosing must always be done on subjects' bed only in sitting position? If dosing is done in a separate room, as subjects walk to their beds following the dosing, will it not affect PK/ variability? The protocol requirement is subjects need to be in semi-reclined position for the first 4 hours. So, as subjects walk following the dosing, will this become a protocol deviation? I tried to look for any regulatory requirement (MHRA) but couldn't find. Kindly let me know if there is any guidance available. Thanks, CR |
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jag009 ★★★ NJ, 2013-10-01 17:20 (4240 d 11:35 ago) @ cr.maroj Posting: # 11583 Views: 4,457 |
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Hi, Not really. In my studies subjects walk to a blood draw room (The room is part of the study space) to do blood draw. It depends on the drug product. With several studies we stated in the protocol that blood draw be carried out with the subjects were sitting down due to potential dizziness. We did that for a night dosing study as well (with catheter for blood draw). John |
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Dr_Dan ★★ Germany, 2013-10-02 12:20 (4239 d 16:35 ago) @ cr.maroj Posting: # 11588 Views: 4,362 |
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Dear CR The general procedure is that dosing is done in a separate room. However, you can deviate from this rule. If e.g. for safety reasons subjects need to be in semi-reclined position for the first 4 hours dosing can be performed in bed. You just need to describe this procedure in the study protocol. You could also state in the protocol that subjects walk to their bed following the dosing. It 's up to you. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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drgunasakaran1 ★★  2013-10-03 06:34 (4238 d 22:20 ago) @ cr.maroj Posting: # 11590 Views: 4,306 |
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Dear CR, ❝ Could you please let me know your opinion, is dosing in a room separate from the clinic permissible? Dosing in a separate room is permissible. We used to dose the subjects in separate dosing stations. ❝ or dosing must always be done on subjects' bed only in sitting position? No. Dosing need not be done on subject's bed only. For some molecules, where you expect immediate hypotension or giddiness, it is preferable to do the dosing in beds. — 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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