Post Study – Safety sample collection [Study Performance]
Dear KRISH
The time for the post study safety sample collection is at the discretion of the Principle Investigator. If an alteration of blood parameters is expected with the study drug it might make sense to delay the safety sample collection. In this case the sample is collected after giving a gap after check out of the last period (= first post study safety assessment) and you might need a second post study safety assessment (=follow up). This is why most of the CROs take for a general BE study the safety sample directly after drawing the last PK sample and before discharging the subject.
I hope this helps
Kind regards
Dr_Dan
The time for the post study safety sample collection is at the discretion of the Principle Investigator. If an alteration of blood parameters is expected with the study drug it might make sense to delay the safety sample collection. In this case the sample is collected after giving a gap after check out of the last period (= first post study safety assessment) and you might need a second post study safety assessment (=follow up). This is why most of the CROs take for a general BE study the safety sample directly after drawing the last PK sample and before discharging the subject.
I hope this helps
Kind regards
Dr_Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Post Study – Safety sample collection krish 2015-02-02 09:43
- Post Study – Safety sample collectionDr_Dan 2015-02-02 11:14