Bioequivalence and Bioavailability Forum

Aisha.ma ☆ United Arab Emirates, 2019-10-07 09:46 (1656 d 05:59 ago) Posting: # 20672 Views: 4,512	how to get t50%GIR-AUC(0-8h) in winnolin? [Software] Post reply
	Dear all, I am a biostatistician, and I have a project about insulin glargine. The parameter t50%GIR-AUC(0-8h) will be analysed, but I don't know how to get this parameter. Can I get it by WinNolin software and which parameter in WinNonlin will be? Edit: Category changed; see also this post #1. [Helmut]

Helmut
★★★

Vienna, Austria,
2019-10-07 11:52
(1656 d 03:52 ago)

@ Aisha.ma
Posting: # 20673
Views: 3,857

POT-50

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Salam Aisha,

t_50% (aka HVD – Half Value Duration, POT-50 – Peak Occupancy Time 50%) is not one of the PK metrics implemented in Phoenix WinNonlin.

If your last sample was scheduled at 8 hours, follow the procedure described in this post.
If you sampled longer, set up a data wizard / filter and include only time points ≤8 h and proceed with #1.

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Aisha.ma ☆ United Arab Emirates, 2019-10-07 18:12 (1655 d 21:32 ago) @ Helmut Posting: # 20675 Views: 3,823	POT-50 Post reply
	W.salam Helmut, Thank you very much. Now I know how to get t50% Cmax via Phoenix WinNonlin. But I want to know t50% AUC(0-8h) (time to 50% of AUC, and my last sample was scheduled at 8 hours). So next what should I do if I know HVD? I hope you help me again. Thank you so much.

Helmut
★★★

Vienna, Austria,
2019-10-07 18:58
(1655 d 20:47 ago)

@ Aisha.ma
Posting: # 20676
Views: 3,865

AUC-apical?

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Hi Ashima,

BTW, are you referring to this guideline?

❝ But I want to know t50% AUC(0-8h) (time to 50% of AUC, and my last sample was scheduled at 8 hours).

Just to clarify: Are you interested in the yellow area?

[image]

Doesn’t look like your GIR cause that’s a PK profile but you get the idea. IIRC, this was called AUC_apical by the “Two Lászlós” (Endrényi and Tóthfalusi). Have to dig it out.

Or this one?

[image]

❝ So next what should I do if I know HVD?

Both are not easy to calculate because HVD is the difference between the two intersections times which you don’t get in Phoenix. I suggest to register at Certara’s forum and post an example project containing the data of one subject.

Ideas:

Modify one of the R-scripts of this thread and call them from Phoenix.
Preliminary NCA (where we calculated 50%C_max and 75%C_max) > Final Parameters Pivoted > Data Wizard > Exclude Cmax_75
Custom Function: New Column Name: Baseline, Formula: 0
Properties: Cmax > Max_Response, Cmax_2 > Threshold
Rename the Data Wizard to PD limits
Set up another NCA-object > Options > Model Type Drug Effect (220)
Therapeutic Response > Drag/drop the Results of PD limits (the mapping should be recognized)
When you execute the NCA-Object you get
AUC_Above_T AUC_Below_T AUC_Net_T
I have to figure out which is what (in my example the last was negative).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Aisha.ma
☆

United Arab Emirates,
2019-10-07 20:43
(1655 d 19:01 ago)

@ Helmut
Posting: # 20677
Views: 3,776

AUC-apical?

Post reply

Hi Helmut,

❝ BTW, are you referring to this guideline?

Maybe the sponsor had consult this guideline before designing the study . Gir is the glucose-infusion rate.

❝ Just to clarify: Are you interested in the yellow area?

❝

[image]

❝ Doesn’t look like your GIR cause that’s a PK profile but you get the idea. IIRC, this was called AUC_apical by the “Two Lászlós” (Endrényi and Tóthfalusi). Have to dig it out.

I need to know time to 50% of GIR-AUC0-8. At the begining, I think that I can use summary table from Phoenix resluts and the function of AUC to get this time, but I am not sure whether this idea is right.
I have search many meterials about glucose-infsion study, this parameter is the secondary end. So it is a common parameter in glucose-infsion study, but I can not find the calculating mathod. :-(

Helmut
★★★

Vienna, Austria,
2019-10-07 20:54
(1655 d 18:51 ago)

@ Aisha.ma
Posting: # 20678
Views: 3,829

Define your terms!

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Hi Aisha,

❝ I need to know time to 50% of GIR-AUC0-8.

That’s not my field. If the sponsor is so clever to demand a certain metric, ask what is exactly meant.

❝ At the begining, I think that I can use summary table from Phoenix resluts and the function of AUC to get this time, but I am not sure whether this idea is right.

No, this will not work.

❝ So it is a common parameter in glucose-infsion study, but I can not find the calculating mathod.

Fantastic. Keep searching. Once you know how it is defined, we can try to come up with a calculation method. Not before. Sorry.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Aisha.ma ☆ United Arab Emirates, 2019-10-07 21:02 (1655 d 18:42 ago) @ Helmut Posting: # 20679 Views: 3,776	Define your terms! Post reply
	Hi Helmut, Thank you so much. You have give me many useful information. I will search continue and I hope other experts in this forum also can help me.

nobody nothing 2019-10-08 12:51 (1655 d 02:53 ago) @ Aisha.ma Posting: # 20681 Views: 3,709	Define your terms! Post reply
	...let me startpage this for you: https://link.springer.com/article/10.1007/s00125-005-1916-y — Kindest regards, nobody

how to get t50%GIR-AUC(0-8h) in winnolin? [Software]

POT-50

POT-50

AUC-apical?

AUC-apical?

Define your terms!

Define your terms!

Define your terms!