chak
☆    

2008-11-26 15:19
(6007 d 00:53 ago)

Posting: # 2808
Views: 7,695
 

 prediction of steady-state PK parameters from SD data [Software]

Dear all,

can we predict/simulate steady-state PK parameters from single oral dose results. Can anyone guide me with information? Is it possible to do this using WinNonlin 5.2.What are the PK parameter of single dose required to perform this simulation?


regards
chak
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2008-11-26 16:01
(6007 d 00:12 ago)

@ chak
Posting: # 2809
Views: 6,806
 

 steady-state PK parameters = SD PK parameters!

Dear chak!

❝ can we predict/simulate steady-state PK parameters from single oral dose

❝ results.


Ehm... PK parameters in steady state are the same as after a single dose. I guess you want to predict/simulate the plasma concentrations?

Please use the search feature of the forum first (we had an example just two weeks ago.

❝ Can anyone guide me with information? Is it possible to do this

❝ using WinNonlin 5.2.


Please do your homework first. There's a nice step-by-step example in WinNonlin's documentation.

❝ What are the PK parameter of single dose required to

❝ perform this simulation?


The PK parameters which defined your model after a single dose. In WinNonlin you can perform simulations on any of the compiled models - and on models you have written yourself. For the simulation you need SD model parameters, the doses and the dosage intervals.

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

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

2008-11-27 18:31
(6005 d 21:41 ago)

@ Helmut
Posting: # 2821
Views: 6,568
 

 steady-state PK parameters = SD PK parameters!

Dear Helmut,

As per the WinNonlin user manual 5.2, for simulation we need to enter model parameters like k10 (elimination rate constant), k01 (absoprtion rate constant), V_F (volume of distibution). from single dose pk data we can get the value of k10 & V_F. But from where we can get the value of K01? can we calculate it from single dose data using WinNonlin. please guide us.

Also for model 11, following value for model parameter have been given in WinNonlin user manual.
K12=1.5, K21=1
Are they constant value? can we consider these value in our simuation?

regards
chak
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2008-11-27 18:51
(6005 d 21:22 ago)

@ chak
Posting: # 2822
Views: 6,582
 

 steady-state PK parameters = SD PK parameters!

Dear chak!

❝ As per the WinNonlin user manual 5.2, for simulation we need to enter

❝ model parameters like k10 (elimination rate constant), k01 (absoprtion

❝ rate constant), V_F (volume of distibution).


Exactly.

❝ from single dose pk data we can get the value of k10 & V_F.


If it's an i.v. administration, you get k10 and V (not V_F) = WinNonlin model 1
If it's an p.o. formulation you get V_F and k10 (models 3, 4, 5, 6)

❝ But from where we can get the value of K01? can we calculate it from

❝ single dose data using WinNonlin.


From your study. If you have only i.v. data, you can only simulate MD i.v.; if you have SD p.o. data, use one of the models mentioned above in order to get k10 first, then start the simulation.

❝ Also for model 11, following value for model parameter have been given in

❝ WinNonlin user manual.

❝ K12=1.5, K21=1

❝ Are they constant value?


Sure, this is an example of a simulation of a two-compartment model. What do you mean by 'constant'?

❝ can we consider these value in our simuation?


No! They are constant given the data - you may not use them for your formulation!!

Once - and last - again (see also this post):
  1. Model your single dose data set
  2. Use these parameters in the simulation
  3. Consider participating in Pharsight's training.

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

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

Denmark,
2008-11-27 20:59
(6005 d 19:13 ago)

@ Helmut
Posting: # 2823
Views: 6,520
 

 steady-state PK parameters = SD PK parameters!

❝ 1. Model your single dose data set

❝ 2. Use these parameters in the simulation

❝ 3. Consider participating in Pharsight's training.


4. Use a model that makes sense for the drug/formulation in your study.


EM.
d_labes
★★★

Berlin, Germany,
2008-11-28 09:29
(6005 d 06:44 ago)

@ ElMaestro
Posting: # 2828
Views: 6,318
 

 The power to know

Dear Chak,

0. Consider participating in a basic course on pharmacokinetics / compartmental models

❝ ❝ 1. Model your single dose data set

❝ ❝ 2. Use these parameters in the simulation

❝ ❝ 3. Consider participating in Pharsight's training

❝ 4. Use a model that makes sense for the drug/formulation in your study.


Regards,

Detlew
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
231 visitors (0 registered, 231 guests [including 11 identified bots]).
Forum time: 17:13 CEST (Europe/Vienna)

Young man, in mathematics you don’t understand things.
You just get used to them.    John von Neumann

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