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When the the infusion speed deviate from the protocol specified [Study As­sess­ment]

posted by ssussu - China, 2018-02-06 10:48  - Posting: # 18362
Views: 5,182

Dear guys,
I am writing this post to consult a problem.
We execute a drug clinical trial, the drug is specifed to administrate by infusion for 0.5 h as a same speed. We set the infusion speed as calculate, but unfortunately, during the infusion, we found a bubble in the infusion tube. For safety, we have to stop the infusion and expel the bubble in the infusion tube, and this stop takes 5min. And to complete the infusion in 0.5h, we speed up the infusion pump speed.

We will assessment the PK for this drug by NCA. What's the effect of this situation? Does the Cmax should be excluded? What about the AUC? What should the investigator to do if the same situation (need to stop temporarily or need to change the infusion speed) occurs next time?

Thank you.


Edit: Category changed; see also this post #1. [Helmut]

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