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krish ☆ India, 2015-02-02 10:43 (3751 d 22:06 ago) Posting: # 14348 Views: 5,457 |
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Dear All, Can any one please let me know the exact time of post study/ Safety sample collection? Is it at the time of exit of the subject from the clinical after the last period or can it be collected after giving a gap after check out of the last period? please clarify. thanks and regards, KRISH.  Edit: Category changed. [Helmut] |
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Dr_Dan ★★ Germany, 2015-02-02 12:14 (3751 d 20:35 ago) @ krish Posting: # 14349 Views: 4,196 |
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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 — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz