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The following message was posted to: PharmPK
Is it possible to run WinNonlin with TID dosing (at 0, 6, and 12 hours)
to calculate AUC (0-24) and possible t 1/2 (from the last dose) using a
noncompartmental approach?
Gary Elfring MS | Senior Director, Statistics |
PTC Therapeutics | 100 Corporate Court | South Plainfield, New Jersey
07080 |
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The following message was posted to: PharmPK
Dear Mr. Gary,
Yes it is possible to run WinNonlin with TID dosing (at 0, 6, and 12
hours) to calculate AUC (0-24) and 1/2 (from the last dose) using a
noncompartmental approach?
What you have to do is that under Dosing regimen enter time of last dose
as 12 hr and dose X mg and then go to the Partial Area tab.. In partial
Area tab. Enter AUC1 lower as 0 and AUC1 upper as 24 for all the
subjects. Then follow the usual procedure of NCA. Finally in the PK
workbook you will get the AUC0-24.
For t 1/2 (from the last dose), you can use Lambda Z or slope ranges
tab. and specify the time interval you want to use for calculating Kel
and WinNonlin will use this Kel to calculate t 1/2. Now if you specify
time interval with 12hr as lower limit and Y>12 as upper limit for Kel
calculation then I think your t 1/2 is automatically calculated form
last dose as time interval specified by you is after last dose.
Hope this will help you.
Thanks & Regards,
Ravi Shankar Pandey
Biostatistician
Mailto:shankpandey.at.gmail.com
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The following message was posted to: PharmPK
Hi Gary - Ravi has already indicated that if you want WinNonlin to assess the Thalf, AUC etc. from the last dose then just ensure that you enter in the time of the last dose as you have defined it in the data. I.e. if you've used a continuous time from first dose and your last dose was at 8hours on the 4th day of dosing then enter 80 hours. If you've split your data up in by Day then you can use Day as one of your Sort variables and that will give you a profile of Day 4 data only when you last dose was at e.g. 8 h.
If you need to 'predict' that profile at some timepoint that you have not actually assessed and you do not want to use Modelling and Simulation then you could use Non Parametric Superposition found under the "Tools" menu. We just had a thread regarding a very similar simulation of TID on the WinNonlin products forum last week using Phoenix WinNonlin 6.1 but the principles are the same in WinNonlin Classic (i.e. versions 5.x) if you haven't upgraded yet.
[login in required - db]
http://www.pharsight.com/extranet/index.php?option=com_kunena&Itemid=5 5&func=view&catid=39&id=220#226
Best regards,
Simon.
--
Simon.Davis.aaa.certara.com
Senior Scientific Consultant
Pharsight- A Certara(tm) Company
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