Learning
objectives
At the conclusion of this course, the students should be able to
• Develop basic understanding
of nonlinear regression and non-linear mixed effects methods
• Build basic population pharmacokinetic models in NONMEM
• Create informative graphical analysis using Splus or R
• Conduct such or more complex analyses with minimal supervision
• Understand the application of these methods to drug development
and regulatory decisions
Course
Pre-requisites
The students attending this course should have
• Knowledge of basic
pharmacokinetic and pharmacodynamic concepts
• Hands on experience with compartmental and noncompartmental
modeling
• Experience with one of the modeling packages such as (but
not limited to) WinNonlin, Scientist, ADAPT etc.
Course Format
The course is divided in
4 sessions spanned over four months and will rely on material available
at Pharmacometrics
Learning Resource. For each session, preparatory material will
be circulated 3 weeks before the session. The students are expected
to conduct analysis provided in the preparatory material and submit
a report at the session. For first three sessions, equal time will
be devoted to didactic teaching and hands-on exercise. The last of
these sessions will be journal club meeting. Each student will choose
a journal article at the conclusion of the third session and will
make presentation to the entire group.
Course coordinator
Pravin Jadhav, Ph.D.
Pharmacometrics reviewer, Office of Clinical Pharmacology
10903 New Hampshire Avenue
Bldg 51, Rm 3117
Silver spring, MD 20903
Phone: 301 796 1510
Course Instructors
Joga Gobburu, Ph.D., Director,
Pharmacometrics
Christoffer Tornoe, Ph.D., Pharmacometrics reviewer
Yaning Wang, Ph.D., Team Leader, Pharmacometrics
Course
outline
Session
I: October 9, 2008
Instructors: Joga Gobburu and Pravin Jadhav
• Preparatory
material (Homework #1 and #2)
(Note: This MS Word document contains supplement files as inserted objects)
• Introduction
• Lecture
1: Introduction to population
modeling
• Lecture
2: Hands on session
(Note: This MS PowerPoint document contains supplement files as inserted
objects)
Session II: October 28, 2008
Instructors: Christoffer Tornoe and Pravin Jadhav
• Preparatory
material (Homework #3)
(Note: This MS word document contains supplement files as inserted objects)
• Introduction
• Lecture
1: Population PK Model
Building
• Lecture
2: Model qualification and
assumption checking
(Note: This MS PowerPoint document contains supplement files as inserted
objects)
Session III: November 13, 2008
Instructors: Yaning Wang
• Lecture
1: NONMEM Estimation methods
Session IV: January 16, 2009
Instructors: Joga Gobburu, Pravin Jadhav, Christoffer Tornoe and Yaning
Wang
• Journal
club meeting (to be posted)
