Log in
RegisterWhen the the infusion speed deviate from the protocol specified [Study Assessment]
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]
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]
Complete thread:
- When the the infusion speed deviate from the protocol specifiedssussu 2018-02-06 10:48 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different PK profile Helmut 2018-02-06 13:28
- Different PK profile ssussu 2018-02-07 02:50
- Different PK profile Helmut 2018-02-07 11:04
- Different PK profile ssussu 2018-02-07 11:42
- Suitable equipment? Helmut 2018-02-07 14:13
- Suitable equipment? ssussu 2018-02-08 04:07
- AUC=f·D/CL Helmut 2018-02-08 10:28
- AUC=f·D/CL ssussu 2018-02-08 11:21
- AUC=f·D/CL Helmut 2018-02-08 21:55
- AUC=f·D/CL ssussu 2018-02-09 00:31
- AUC=f·D/CL Helmut 2018-02-08 21:55
- AUC=f·D/CL ssussu 2018-02-08 11:21
- AUC=f·D/CL Helmut 2018-02-08 10:28
- Suitable equipment? ssussu 2018-02-08 04:07
- Suitable equipment? Helmut 2018-02-07 14:13
- Different PK profile ssussu 2018-02-07 11:42
- Different PK profile Helmut 2018-02-07 11:04
- Different PK profile ssussu 2018-02-07 02:50
- When the the infusion speed deviate from the protocol specified ElMaestro 2018-02-07 13:20
- When the the infusion speed deviate from the protocol specified ssussu 2018-02-08 04:23
- Different PK profile Helmut 2018-02-06 13:28
Ing. Helmut Schütz