# ISOP Webinar, July 14, 2021, 11:00am EDT: Understanding the Methodology and Uses of Some New Features in NONMEM 7.5: Clinical Trial Design Evaluation and Optimization, and Delay Differential Equations

From: Bauer, Robert <Robert.Bauer>
Date: Tue, 13 Jul 2021 15:03:48 +0000

Dear nmusers:

You are invited to the following webinar:

[https://insp.memberclicks.net/assets/site/New%20Isop%20logo.RS.jpg]

ISoP MCS SIG Webinar Series
presents
Robert Bauer, Ph.D.
Pharmacometrics and PK/PD Modeling & Simulation, ICON Clinical Research, LL=
C.
Seminar Title
Understanding the Methodology and Uses of Some New Features in NONMEM 7.5: =
Clinical Trial Design Evaluation and Optimization, and Delay Differential E=
quations
July 14, 2021

Abstract

Two major features newly developed in NONMEM 7.5 are modelling delays, and =
clinical trial design evaluation and optimization. Algorithms that model d=
elays for biological problems are explained, particularly cell lifespan and=
cell maturation are discussed. These delays may be modelled either as a =
discrete delay, or as a distributed delay, the most common being gamma dist=
ributed and Weibull distributed. The numerical integrator tools and techniq=
ues required to model each type of delay is discussed, describing their beh=
avior, and their pros and cons in terms of ease of use, efficiency, stabili=
ty, and stiffness. In addition, the tools and techniques of clinical trial=
design and evaluation and optimization are discussed. The goal of clinica=
l trial design is to find times and doses that are most efficient and econo=
mical to obtain the desired information about a therapeutic. In particular,=
good quality parameters of the PK/PD model describing that therapeutic in =
humans desired. For example, we may want to determine the sample times whi=
ch gives us the lowest possible standard errors to the population parameter=
s, or determine cohorts that a have the ideal combination of dosing regimen=
and sample times. Often we wish to also take into account the robustness =
of a design, that is, determine a sampling strategy that is rich enough to =
account for the variations in PK/PD parameters that are likely to occur in =
a set of subjects.

Registration

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