Bioequivalence and Bioavailability Forum

Suitable equipment? [Study As­sess­ment]

posted by ssussu – China, 2018-02-08 05:07 (2436 d 16:49 ago) – Posting: # 18377
Views: 9,973

Hi Helmut,

Thank you for your patience.

❝ ❝ So, you mean the Cmax and the AUC both will equal the one with a constant rate infusion?

❝

❝ Yes!

I thought the AUC would be effect because I saw the the black area in the below picture. Now i know the AUC is only depend on the dose as you said.

❝ For the next time I strongly recommend infusion pumps (yeah, I know, expensive): Exact infusion rates, no bubbles, no problems.

Yes, they used the infusion pumps, and I don't know why it occurs bubbles and I need to do more detailed investigation.

❝ If you would have kept the original infusion rate (after the five minutes stop), i.e., complete it at 35 minutes, you would have seen a C_max which is 0.35% (!) lower than expected with the planned schedule – if you have an early sampling time point. If not, you will observed a lower C_max. How much lower depends on the sampling schedule and the elimination rate. Theoretically the AUC is not affected (depends only on the dose).

Could I say (theoretically) that no matter how long will I stop the infusion,only if I complete infusion at 0.5h，the Cmax will be same with constant rate infusion for 0.5h?

❝ Why did it take the nurse five minutes to expel the bubble? In my experience about one minute should be sufficient.

Yes, actually they take 2min and I exaggerate it to 5min, want to see the effect if the stop time is not short enough to be ignore.

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

• When the the infusion speed deviate from the protocol specified ssussu 2018-02-06 10:48 [Study As­sess­ment] 
  • 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
  • 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