exlusion of subject due to vomiting [Regulatives / Guidelines]
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].
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].
Complete thread:
- exlusion of subject due to vomitingdocksr 2015-05-07 08:30 [Regulatives / Guidelines]