The workshop will demonstrate how NONMEM® and PDx-Pop®
can be used to solve practical examples. Attendees will
learn from didactic sessions and hands-on practical experience.
The workshop will also demonstrate the role of population
analysis in drug development and the regulatory process.
As a departure from our traditional workshop format, each workshop
participant will be required to bring a laptop with licensed copies
of NONMEM version VI and PDx-Pop version 2.0 software installed.
This will allow participants to work through the problems with the
instructors, develop thorough understanding of the software, and
establish confidence in applying the software to population
pharmacokinetic problems.
This workshop is targeted toward individuals interested in learning
how to solve population pharmacokinetic problems. We have designed
the workshop in a general manner in order to serve a wide background
of participants.
Workshop
Agenda:
Day
1:
Day
2:
9:00 - 9:15
Course Introduction
9:15 -11:15 Introduction to Population Pharmacokinetics
Population Analysis Principles/Methodologies Model Development,
Evaluation
11:15 - 11:30 Break
11:30- 12:30 Analysis of Data from One Subject: Example
(PK, Variance Models) Introduction
to NONMEM Files and Analysis
12:30 - 1:30 Lunch
1:30 - 3:30 Analysis of Data from One Subject (continued)
3:30 - 3:45 Break
3:45 - 5:30 Population Analysis with No Covariates: Example
(PK, Intersubject, Variance Models) NONMEM
Files, Population Analysis
8:30 - 9:00
Population Analysis with No Covariates (continued)
9:00 - 10:00 Population Analysis with Covariates: NONMEM
Files Exploratory
Analysis Modeling
Building Example
10:00 - 10:15 Break
10:15 - 11:30 Population Analysis with Covariates (continued)
11:30 - 12:30 Lunch
12:30 - 1:30 Population Analysis with Covariates (continued)
1:30 - 2:30 User-Written Models in NONMEM (PK-PD Analysis)
Example
NONMEM
Files PK-PD
Modeling
2:30 - 2:45 Break
2:45 - 3:30 PK-PD Population Analysis (continued)
3:30 - 5:00 Population Analysis Final Example & Practice
Session
