Aisha.ma
☆    

United Arab Emirates,
2019-10-07 07:46
(615 d 09:39 ago)

Posting: # 20672
Views: 3,004
 

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

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? :confused:


Edit: Category changed; see also this post #1[Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-10-07 09:52
(615 d 07:33 ago)

@ Aisha.ma
Posting: # 20673
Views: 2,583
 

 POT-50

Salam Aisha,

t50% (aka HVD – Half Value Duration, POT-50 – Peak Occupancy Time 50%) is not one of the PK metrics implemented in Phoenix WinNonlin.
  1. If your last sample was scheduled at 8 hours, follow the procedure described in this post.
  2. If you sampled longer, set up a data wizard / filter and include only time points ≤8 h and proceed with #1.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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 16:12
(615 d 01:12 ago)

@ Helmut
Posting: # 20675
Views: 2,552
 

 POT-50

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.:confused: Thank you so much.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-10-07 16:58
(615 d 00:27 ago)

@ Aisha.ma
Posting: # 20676
Views: 2,592
 

 AUC-apical?

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 AUCapical 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%Cmax and 75%Cmax) > 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 🖖
Helmut Schütz
[image]

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 18:43
(614 d 22:41 ago)

@ Helmut
Posting: # 20677
Views: 2,519
 

 AUC-apical?

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 AUCapical 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
★★★
avatar
Homepage
Vienna, Austria,
2019-10-07 18:54
(614 d 22:31 ago)

@ Aisha.ma
Posting: # 20678
Views: 2,515
 

 Define your terms!

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 🖖
Helmut Schütz
[image]

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 19:02
(614 d 22:23 ago)

@ Helmut
Posting: # 20679
Views: 2,500
 

 Define your terms!

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 10:51
(614 d 06:34 ago)

@ Aisha.ma
Posting: # 20681
Views: 2,474
 

 Define your terms!


Kindest regards, nobody
Activity
 Admin contact
21,518 posts in 4,498 threads, 1,523 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Sunday 17:25 CEST (Europe/Vienna)

A refund for defective software might be nice,
except it would bankrupt the entire software industry
in the first year.    Andrew S. Tanenbaum

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5