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Introductory NONMEM & PDx-Pop

Date of Meeting: 10-11 April 2018

Location: Business Training Center, Howard County, Maryland

Instructors: Robert J. Bauer, Ph.D., Brian Sadler, Ph.D., Indrajit Das, Ph.D

Agenda Items:

DAY 1 - "Introductory NONMEM & PDx-Pop" - Presentation: Time

9:00 – 1. Course Introduction 9:15 AM

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 9:15 – 2. - First Order 11:15 AM - First Order Conditional Estimation - Model Development & Diagnostics - data exploration - structural and error model development - goodness of fit diagnostics - diagnostic plots

11:15 – 3. Coffee Break 11:30 AM

Analysis of Data from One Subject (3hrs) 11:30 – 4. - Example (PK, Variance Models) 12:30 AM - Introduction to NONMEM Files and Analysis

12:30 – 5. Lunch 1:30 AM

1:30 – 6. Analysis of Data from One Subject (continued) 3:30 PM

3:30 – 7. Break 3:45 PM

3:45 – 8. Population Analysis with No Covariates (1.75hrs) 5:30 PM

DAY 2 – "Introductory NONMEM & PDx-Pop" - Presentation: Time

8:30 – 1. Population Analysis with No Covariates (continued) 9:00 AM

Population Analysis with Covariates (3.25hrs) - NONMEM Files 9:00 – 2. - Exploratory Analysis 10:00 AM - Model Building Example

10:00 – 3. Break 10:15 AM

10:15 – 4. Population Analysis with Covariates (continued) 11:30 AM

11:30 – 5. Lunch 12:30 AM

12:30 – 6. Population Analysis with Covariates (continued) 1:30 PM

Introduction to Model Evaluation Methods - User-Written Models in NONMEM (1.75hrs) 1:30 – 7. * A PK-PD Example 2:30 PM * NONMEM Files

2:30 – 8. Break 2:45 PM

User-Written Models (continued) 2:45 – 9. PK-PD Model Problem 3:30 PM

3:30 – 10. Population Analysis Final Example & Practice Session 5:00 PM