Back to the Top
HI all,
I have a small project I need assistance with as I have not used WinNonlin in several years and am
unfamiliar with model simulations in this new version and don't have the bandwidth to come to speed.
I have a single compassionate use patient receiving oral capsules of Drug A (FDA has allowed us to
go to this single patient in the absence of any GLP tox as this is a cancer patient who has
exhausted all options). I have blood levels following qd dosing (I will have bid data sometime
today). Enteric coated capsules so minimal drug at 0-1 hr post dose; Tmax is 4 h; t1/2 is
approximately 4 hr (not affected by dose so far). Dog data that suggests F% is 33%, but not F%
data in humans. Clinical team is wanting up the dose and go to tid dosing. I'm wanting to run
simulations on this to see if there is any benefit to going to tid vs bid or if the steady state
will be similar.
Please email me if interested - it is a really small project.
Cheers
Jeff
Jeffrey Larson, Ph.D, DABT
Vice President, Nonclinical Development
Salarius Pharmaceuticals
Back to the Top
To simulate TID, need to have QD plasma concentration curve. Thanks.
Regard,
Jennifer Yang
[And some other replies that should have gone directly to Jeff ;-) db]
Back to the Top
Dear Jeff,
With the information you provide trough concentrations will certainly be increased by tid dosing.
Whether this is beneficial very much depends on the drug itself. As an example, for some antibiotics
it's better to have high peak concentrations (e.g. gentamicin), while for others a long period over
a certain threshold is more important (beta-lactams). Thus, splitting a given daily dose from qd to
tid may be beneficial or harmful.
Best regards,
Uwe
[Try https://www.boomer.org/c/p4/js/w1401/index1.html once you get the PK parameters ;-) db]
Back to the Top
What is meant by QD plasma concentration curve?
[Have a look at https://www.boomer.org/ios/cs/ :-) db]
Back to the Top
Why not use superposition method? No modeling expertise required. Do you know the minimum desirable
plasma concentrations?
Good Luck.
Aziz Karim
[https://www.boomer.org/c/p4/c15/c1505.html might be useful - db]
Back to the Top
Because they don't teach anything practical like this any more. It is all non-men and simcyp
Dennis Bashaw
Back to the Top
Dear Aziz Karim,
I think there is no such limitation but it must follow linear PK.
Dr .Zafar Iqbal (T.I.)
Meritorious Professor
Department of Pharmacy
University of Peshawar
PharmPK Discussion List Archive Index page |
Copyright 1995-2014 David W. A. Bourne (david@boomer.org)