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Welcome

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

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Welcome

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  1. 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 Introduction

  2. Course format • Session I • Introduction to population pharmacokinetics • Session II • Population pharmacokinetic model building • Session III • NONMEM estimation methods • Session IV • Journal club meeting Introduction

  3. 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) Introduction

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