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Ambulatory missing blood samples in EMEA study [Regulatives / Guidelines]

posted by pash413 - India, 2017-10-13 13:10  - Posting: # 17894
Views: 1,815

(edited by pash413 on 2017-10-13 13:26)

Dear All
In BE study of modified release drug product for EMEA submission can we dropped the subject in clinical phase if he/she was not reported for continuous three or more ambulatory blood sample collections.

If we dropped the subject we need to analyse the renaming blood samples as per EMEA GL. However we should not included in final statastical analysis.

As per EMEA GL "Subjects should not be excluded from the statistical analysis if AUC(0-t) covers less than 80% of AUC(0-∞), but if the percentage is less than 80% in more than 20% of the observations then the validity of the study may need to be discussed. This does not apply if the sampling period is 72 h or more and AUC(0-72h) is used instead of AUC(0-t)".

Is there any regulatory concern if we have not included the drop out subject(s) due to ambulatory missing samples in the statastical analysis.

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