Introductory NONMEM & PDx-Pop Date of Meeting: 1 – 2 March, 2016 Location: Doubletree by Hilton San Francisco Airport, 835 Airport Boulevard, Burlingame, CA 94010 Instructors: Robert J. Bauer, Ph.D., Brian Sadler, Ph.D. Agenda Items: DAY 1 - "Introductory NONMEM & PDx-Pop" - Presentation: Time 1. Course Introduction 9:00 – 9:15 AM 2. Introduction to Population Pharmacokinetics (2hrs) - Classical Population Analysis Principles/Methodologies - Sums of Squares Objective Functions - Extended Least Squares - Fixed and Random effects - Population Analysis Methods - First Order - First Order Conditional Estimation - Model Development & Diagnostics - data exploration - structural and error model development - goodness of fit diagnostics - diagnostic plots 9:15 – 11:15 AM 3. Coffee Break 11:15 – 11:30 AM 4. Analysis of Data from One Subject (3hrs) - Example (PK, Variance Models) - Introduction to NONMEM Files and Analysis 11:30 – 12:30 AM 5. Lunch 12:30 – 1:30 AM 6. Analysis of Data from One Subject (continued) 1:30 – 3:30 PM 7. Break 3:30 – 3:45 PM 8. Population Analysis with No Covariates (1.75hrs) 3:45 – 5:30 PM Page 1 of 2 DAY 2 – "Introductory NONMEM & PDx-Pop" - Presentation: Time 1. Population Analysis with No Covariates (continued) 8:30 – 9:00 AM 2. Population Analysis with Covariates (3.25hrs) - NONMEM Files - Exploratory Analysis - Model Building Example 9:00 – 10:00 AM 3. Break 10:00 – 10:15 AM 4. Population Analysis with Covariates (continued) 10:15 – 11:30 AM 5. Lunch 11:30 – 12:30 AM 6. Population Analysis with Covariates (continued) 12:30 – 1:30 PM 7. Introduction to Model Evaluation Methods - User-Written Models in NONMEM (1.75hrs) * A PK-PD Example * NONMEM Files 1:30 – 2:30 PM 8. Break 2:30 – 2:45 PM 9. User-Written Models (continued) PK-PD Model Problem 2:45 – 3:30 PM 10. Population Analysis Final Example & Practice Session 3:30 – 5:00 PM Page 2 of 2