Tutorial for $DESIGN in NONMEM: Clinical trial evaluation and optimization.

ABSTRACT: This NONMEM tutorial shows how to evaluate and optimize clinical trial designs, using algorithms developed in design software, such as PopED and PFIM 4.0. Parameter precision and model parameter estimability is obtained by assessing the Fisher Information Matrix (FIM), providing expected model parameter uncertainty. Model parameter identifiability may be uncovered by very large standard errors or inability to invert an FIM. Because evaluation of FIM is more efficient than clinical trial simulation, more designs can be investigated, and the design of a clinical trial can be optimized. This tutorial provides simple and complex pharmacokinetic/pharmacodynamic examples on obtaining optimal sample times, doses, or best division of subjects among design groups. Robust design techniques accountin

SUBMITTER: Bauer RJ 

PROVIDER: S-EPMC8674001 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature