• Session I
• Session II
• Session III
• Session IV

offered at

Department of Pharmaceutics
Virginia Commonwealth University, Richmond, VA

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)

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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)

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Session III: November 13, 2008
Instructors: Yaning Wang

• Lecture 1: NONMEM Estimation methods

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Session IV: January 16, 2009
Instructors: Joga Gobburu, Pravin Jadhav, Christoffer Tornoe and Yaning Wang

• Journal club meeting (to be posted)