exlusion of subject due to vomiting [Regulatives / Guidelines]

posted by docksr – India, 2015-05-07 10:30 (4065 d 02:13 ago) – Posting: # 14773
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(edited on 2015-05-07 17:57)

in a bioequivalence study if the subject is withdrawan due to vomiting, his blood samples may be analyzed for safety purpose but the data will not be considered for statistical analyssis. I can understand if the samples are analyzed till the time of vomiting to establish any higher concentrations of the study drug. My query is; the purpose of analysis for establishing safety beyond that point.

Edit: Don’t shout! Post unto others as you would have others post unto you. It’s nice to start your post with a salutation, and include a signature as well. Please see the Forum’s Policy [Dr_Dan].

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