Outliers: reasons to not analyse? [Outliers]

posted by mittyri – Russia, 2014-01-30 21:14 (3791 d 20:25 ago) – Posting: # 12298
Views: 9,470

Dear Auditor, Dr_Dan, Erkin and all members,

Could you explain your practice and guideline interpretation:

If we state in the protocol the reasons to exclude the results of subjects from analysis (according to the EMA guide), does it mean that the analysis of these samples should be performed and presented anyway?
e.g. vomiting was begun in 1 hour after dosing. After that the volunteer was excluded from the study. The plasma concentration-time profile will be evedently unreliable. should we perform the sample analysis of this subject?

Could you indicate any reasons/situations when the samples analysis can be not performed for some of subjects?

PS I met very strange opinion to this issue. I'm in doubt at this moment :confused:

Kind regards,

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