# (300-OD) Advanced PK/PD Modeling using Phoenix WinNonlin

## Cost - $2395 (Academia $1198)

This course aims to give the course participants confidence and encouragement to learn advanced topics in PK/PD data analysis, and to practice on real life case studies from discovery, preclinical and development. Lectures cover many topics including nonlinear absorption, nonlinear disposition, binary PD outcomes, experimental design, target mediated drug disposition, instantaneous and delayed drug responses, effect-compartment, turnover and binding models, modeling tolerance and rebound, transduction, and an introduction to population PK.

**Course Length**: This course is expected to take approximately 40 hours to complete. Students will have access to the course materials and videos for a period of three years.

**Software Used**: Phoenix WinNonlin and Phoenix NLME. A temporary license is provided to subscribers of this course.

**Prerequisites**: Completion of the Intermediate level PK/PD modeling course (200) using Phoenix WinNonlin (or equivalent experience) is necessary to have a good understanding of Phoenix WinNonlin and the user model language.

# Instructors

## Tom Jones

**Tom Jones** has helped thousands of scientists become proficient with using Certara software in their research in the pharmaceutical industry. After completing his Ph.D. in analytical chemistry, he spent several years as an assistant professor, during which time he applied molecular modeling to teaching and research in chemistry, and then came to Certara, where for 18 years he has applied his passion for teaching scientific software applications. At first Tom was focused exclusively on molecular modeling applications in drug discovery and later broadened his expertise to include informatics and PK/PD modeling and analysis. He has created many training manuals, and you may very well have heard his voice in one of the numerous webinars and video demos he has created to help scientists become more proficient with Certara software.

## Dan Weiner

**Dan Weiner** has extensive drug development experience and has served as an expert consultant to the U.S. Food and Drug Administration (FDA) on pharmacokinetic modeling and bioequivalence assessment. Prior to his previous tenure with Certara/Pharsight as a Senior Vice President and Chief Science Officer, Dr. Weiner held several management positions with Merrell Dow Pharmaceuticals; Statistical Consultants, Inc.; Syntex Development Research; Quintiles; and IVAX Research. Dr. Weiner graduated from the University of Kentucky with a doctoral degree in Mathematical Statistics, with emphasis on compartmental modeling. He is the original designer/author of the WinNonlin family of PK/PD Modeling Software now used by over 1,000 institutions. He is the co-author of Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, now in its 5th ed. Dr. Weiner is an Adjunct Associate Professor with Division of Pharmacotherapy and Experimental Therapeutics in the School of Pharmacy, University of North Carolina and is an Affiliate Professor of Pharmacometrics, Center for Translational Medicine in the School of Pharmacy at the University of Maryland. During his career he has provided PK/PD training to over 2,000 students. He is currently a consultant in model-based drug development.

# Training material

- Welcome!
- Course Navigation
- Course Materials
- How to get help
- Questions
- Course Introduction
- Nonlinear Absorption
- Nonlinear Absorption (Part 1)
- Quiz 1: Nonlinear Absorption
- Nonlinear Absorption (Part 2)
- Quiz 2: Nonlinear Absorption
- Nonlinear Absorption (Part 3)
- Quiz 3: Nonlinear Absorption
- PK3 Exercise: Zero and First Order Absorption
- Introduction to PK3: Zero and First Order Absorption
- Instructions for PK3, Part 1: Exploratory Data Analysis
- Solution to PK3, Part 1: Exploratory Data Analysis
- Instructions for PK3, Part 2: Create First Order Model
- Solution to PK3, Part 2: Create First Order Model
- Instructions for PK3, Part 3: Create Zero Order Model
- Solution to PK3, Part 3: Create Zero Order Model
- PK30 Exercise: Subcutaneous Dosing of Hormone
- Introduction to PK30: Subcutaneous Dosing of Hormone
- Instructions for PK30, Part 1: Exploratory Data Analysis
- Solution to PK30, Part 1: Exploratory Data Analysis
- Instructions for PK30, Part 2: Obtain Initial Estimates by NCA
- Solution to PK30, Part 2: Obtain Initial Estimates by NCA
- Instructions for PK30, Part 3: Define Structural Model
- Solution to PK30, Part 3: Define Structural Model
- Instructions for PK30, Part 4: Enter Initial Estimates and Run Model
- Solution to PK30, Part 4: Enter Initial Estimates and Run Model
- PK42 Exercise: Nonlinear Absorption Models
- Introduction to PK42: Nonlinear Absorption Models
- Instructions for PK42, Part 1: Exploratory Data Analysis
- Solution to PK42, Part 1: Exploratory Data Analysis
- Instructions for PK42, Part 2: Create Initial Model
- Solution to PK42, Part 2: Create Initial Model
- Instructions for PK42, Part 3: Create Model with Saturating Absorption
- Solution to PK42, Part 3: Create Model with Saturating Absorption
- Nonlinear Disposition
- Nonlinear Disposition (Part 1)
- Quiz 4: Nonlinear Disposition
- Nonlinear Disposition (Part 2)
- Quiz 5: Nonlinear Disposition
- PK19 Exercise: Nonlinear Metabolite Kinetics
- Introduction to PK19: Nonlinear Metabolite Kinetics
- Instructions for PK19, Part 1: Exploratory Data Analysis
- Solution to PK19, Part 1: Exploratory Data Analysis
- Instructions for PK19, Part 2: Create Drug Model with Linear Disposition
- Solution to PK19, Part 2: Create Drug Model with Linear Disposition
- Instructions for PK19, Part 3: Create Drug Model with Nonlinear Disposition
- Solution to PK19, Part 3: Create Drug Model with Nonlinear Disposition
- Instructions for PK19, Part 4: Create Model for both Drug and Metabolite
- Solution to PK19, Part 4: Create Model for both Drug and Metabolite
- PD Models for Direct Effects and Effect Compartment Models
- Classical PD Models for Direct Effects and Effect Compartment Models (Part 1)
- Quiz 6: PD Models
- Classical PD Models for Direct Effects and Effect Compartment Models (Part 2)
- Quiz 7: PD Models
- PD22 Exercise: Effect Compartment Model
- Introduction to PD22 Exercise
- Instructions for PD22, Part 1: Exploratory Data Analysis
- Solution to PD22, Part 1: Exploratory Data Analysis
- Instructions for PD22, Part 2: Create PK Model
- Solution to PD22, Part 2: Create PK Model
- Instructions for PD22, Part 3: Create PKPD Model (freeze PK)
- Solution to PD22, Part 3: Create PKPD Model (Freeze PK)
- Instructions for PD22, Part 4: Create PKPD Model (Simultaneous Fit)
- Solution to PD22, Part 4: Create PKPD Model (Simultaneous Fit)
- Instructions for PD22, Part 5: Create Table Function Link Model
- Solution to PD22, Part 5: Create Table Function Link Model
- Modeling of Binary Outcomes
- Modeling of Binary Outcomes (Part 1)
- Quiz 8: Binary PD Outcomes
- Modeling of Binary Outcomes (Part 2)
- Quiz 9: Modeling Binary Outcomes
- Logistic Regression Exercise
- Introduction to Logistic Regression Exercise
- Instructions for Logistic Regression, Part 1: Exploratory Data Analysis
- Solution to Logistic Regression, Part 1: Exploratory Data Analysis
- Instructions for Logistic Regression, Part 2: Create Logistic Regression Model
- Solution to Logistic Regression, Part 2: Create Logistic Regression Model
- Instructions for Logistic Regression, Part 3: Plot Model Results
- Solution to Logistic Regression, Part 3: Plot Model Results
- Intro to Turnover/Indirect Response Models
- Intro to Turnover/Indirect Response Models (Part 1)
- Quiz 10: Indirect Response Models
- Intro to Turnover/Indirect Response Models (Part 2)
- Quiz 11: Indirect Response Models
- PD4 Exercise: Indirect Response Models
- Introduction to PD4: Indirect Response Models
- Instructions for PD4, Part 1: Exploratory Data Analysis
- Solution to PD4, Part 1: Exploratory Data Analysis
- Instructions for PD4, Part 2: Create Built-In Model
- Solution to PD4, Part 2: Create Built-In Model
- Instructions for PD4, Part 3: Create Textual Model with Tlag
- Solution to PD4, Part 3: Create Textual Model with Tlag
- Instructions for PD4, Part 4: Create Precursor/Pool Models
- PD4, Part 4: Create Precursor/Pool Models
- PD38 Exercise: Turnover Model with Repeated Dosing
- Introduction to PD38: Turnover Model with Repeated Dosing
- Instructions for PD38, Part 1: Exploratory Data Analysis
- Solution to PD38, Part 1: Exploratory Data Analysis
- Instructions for PD38, Part 2: Create Model
- Solution to PD38, Part 2: Create Model
- Modeling Tolerance and Rebound
- Modeling Tolerance and Rebound
- Quiz 12: Tolerance and Rebound
- PD35 Exercise: Transduction Models
- Introduction to PD35: Transduction Models
- Instructions for PD35, Part 1: Exploratory Data Analysis
- Solution to PD35, Part 1: Exploratory Data Analysis
- Instructions for PD35, Part 2: Create Models
- Solution to PD35, Part 2: Create Models
- Instructions for PD35, Part 3: Compare Models
- Solution to PD35, Part 3: Compare Models
- Instructions for Transduction Models, Part 4: Transit Command
- Solution to PD35, Part 4: Transit Command
- Fate of mAbs and Target-Mediated Drug Disposition
- Fate of mAbs and Target-Mediated Drug Disposition (Part 1)
- Quiz 16: TMDD
- Fate of mAbs and Target-Mediated Drug Disposition (Part 2)
- Quiz 17: TMDD
- TMDD Exercise: Target-Mediated Drug Disposition
- Introduction to TMDD Exercise
- Instructions for TMDD Exercise, Part 1: Exploratory Data Analysis
- Solution to TMDD, Part 1: Exploratory Data Analysis
- Instructions for TMDD Exercise, Part 2: Create Two-Compartment PK Model
- Solution to TMDD, Part 2: Create Two-Compartment PK Model
- Instructions for TMDD Exercise, Part 3: Create Parallel Elimination Model
- Solution to TMDD, Part 3: Create Parallel Elimination Model
- Instructions for TMDD Exercise, Part 4: Create TMDD Model
- Solution to TMDD, Part 4: Create TMDD Model
- Experimental Design
- Practical Experimental Design Considerations for PK and PD Experiments (Part 1)
- Quiz 18: Experimental Design
- Practical Experimental Design Considerations for PK and PD Experiments (Part 2)
- Quiz 19: Experimental Design
- Practical Experimental Design Considerations for PK and PD Experiments (Part 3)
- Quiz 20: Experimental Design
- Introduction to Population Modeling 1
- Intro to Population Modeling 1 (Part 1)
- Quiz 13: Population Modeling 1
- Intro to Population Modeling 1 (Part 2)
- Quiz 14: Population Modeling 1
- Intro to Population Modeling 1 (Part 3)
- Quiz 15: Population Modeling 1
- Introduction to Population Modeling 2
- Introduction to Population Modeling 2 (Part 1)
- Quiz 21: Population Modeling 2
- Introduction to Population Modeling 2 (Part 2)
- Quiz 22: Population Modeling 2
- Introduction to Population Modeling 2 (Part 3)
- Quiz 23: Population Modeling 2
- Introduction to Population Modeling 2 (Part 4)
- Quiz 24: Population Modeling 2
- Introduction to Population Modeling 2 (Part 5)
- Quiz 25: Population Modeling 2
- Post-Hoc Exercise: Use of a Satellite PK Study to Generate Post-Hoc Estimates for a Sparsely Sampled PD Study
- Introduction to the Satellite PK Exercise
- Instructions for Satellite PK, Part 1: Exploratory Data Analysis
- Solution to Post-Hoc Estimates, Part 1: Exploratory Data Analysis
- Instructions for Satellite PK, Part 2: Create PK Model
- Solution to Post-Hoc Estimates, Part 2: Create PK Model
- Instructions for Satellite PK, Part 3: Create Population Model
- Solution to Post-Hoc Estimates, Part 3: Create Population Model
- Instructions for Satellite PK, Part 4: Compute Post-hoc Estimates
- Solution to Post-Hoc Estimates, Part 4: Compute Post-Hoc Estimates
- Remifentanil Exercise: Population Modeling
- Introduction to Remifentanil Exercise
- Instructions for Remifentanil Exercise, Part 1: Exploratory Data Analysis
- Remifentanil Exercise, Part 1: Exploratory Data Analysis
- Instructions for Remifentanil Exercise, Part 2: Create Individual Model
- Remifentanil Exercise, Part 2: Create Individual Model
- Instructions for Remifentanil Exercise, Part 3: Create Base Population Model
- Remifentanil Exercise, Part 3: Create Base Population Model
- Instructions for Remifentanil Exercise, Part 4: Include Covariates in Population Model
- Remifentanil Exercise, Part 4: Include Covariates in Population Model
- Course Recap
- Thank you from Certara University Training
- End of On-Demand Course Survey