1. Pravin.Jadhav@fda.hhs.gov October 09, 2008 Introduction 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

2. Pravin.Jadhav@fda.hhs.gov October 09, 2008 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

3. Pravin.Jadhav@fda.hhs.gov October 09, 2008 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)