A Sample Size Computation Method For Nonlinear Mixed Effects Models 
by Dongwoo Kang, Janice B. Schwartz and Davide Verotta


Windows Version V.1.0 2004.09.07

Contents

The zip file includes 4 kinds of Splus scripts:
size.ssc: main program, also defines number of observations,
degree of variability, type I & II error.
size-model-nn.ssc : definition of parameters, dose, testing hypothesis,
etc. for model nn.
size-program-nn.ssc: part of the main program and subroutines for model nn.
size-compute.ssc: main calculation program.

Installation

Create a working directory (e.g., c:\work\sample-size is the default) and 
extract the zip file. After opening the main program (size.ssc) in Splus, the 
program is ready to be run. Change the names of the files if necessary,
ie, depending on their location. Change/modify model parameters and 
other things (e.g., parameter values, measurement times, degree of difference, 
testing hypothesis, relative group size, etc.) using size-model-nn.ssc. 
Sophisticated users of Splus may want to modifity the main program further 
to do more from one run.

Application 

The V.1.0 contains steady-state PK model and 1 compartment PK model with 1st 
order absorption which are demonstrated in the paper: 
A Sample Size Computation Method For Nonlinear Mixed Effects Models 
with Applications to Pharmacokinetics Models
by Dongwoo Kang, Janice B. Schwartz and Davide Verotta
Statistics in Medicine 2004;23:2551-2566.


Contact

Please forward your comments and concerns regarding the program to
Dongwoo Kang, PhD
Clinical Pharmacology
Pfizer Global R&D
10578 Science Center Drive / B95
San Diego, CA 92121
dongwoo.kang@pfizer.com