Transcript Leveraging Prior Knowledge in Guiding Drug Development and

Welcome
• Learning objectives
– Develop basic understanding of nonlinear regression and
non-linear mixed effects methods
– Build basic population pharmacokinetic models in NONMEM
– Create informative graphical analysis
– Conduct such or more complex analyses with minimal
supervision
– Understand the application of these methods to drug
development and regulatory decisions
• To make this course mutually useful
– ASK QUESTIONS
• AsK quEsTioNs
– aSk QuesTIons
October 09, 2008
Introduction
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Course format
• Session I
– Introduction to population pharmacokinetics
• Session II
– Population pharmacokinetic model building
• Session III
– NONMEM estimation methods
• Session IV
– Journal club meeting
October 09, 2008
Introduction
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Today’s Agenda
• Introductions
• Q & A on homework assignments 1 and 2
• Lecture 1 (Dr. Joga Gobburu)
– 10:30 AM-11:30 AM (60 mins)
• Break
• Lecture 1 continued
– 11:45 AM-1:00 PM (75 mins)
• Lunch break
• Hands on session (Dr. Pravin Jadhav)
– 2:00 PM-4:00 PM (2 hr)
• Pharmacometrics @ FDA
– 4:00 PM-5:00 PM (60 mins)
October 09, 2008
Introduction
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