Bioequivalence and Bioavailability Forum

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.