# (201-OD) Intermediate Population Modeling using Phoenix NLME

## Cost - $1,440 (Academia $720)

# Course Description

The course will provide an overview of biological systems exhibiting delays, concepts of lifespan driven pharmacodynamic response, modeling of cell maturation, and nonlinear mixed effect lifespan models. Delay differential equations (DDEs) will be introduced and implemented. The course will consist of both lectures and hands-on computer exercises. Source codes for DDE based PK/PD models and data will be provided to the participants.

The fee is in US dollars and includes training materials, tea, coffee and lunch. All travel, accommodation and evening meal expenses are the responsibility of the attendee. Contact info@certarauniversity.com for academic discount

All attendees are required to provide their own laptop for use during the course. Please bring a computer mouse.

View Session Dates & Locations

# Software Used

Phoenix WinNonlin

A temporary license is provided to subscribers of this course approximately two weeks prior to the course.

# Course Length

1 Day

# Prerequisites

Participants need to be comfortable with editing PK and PK/PD models in Phoenix Modeling Language (PML).

Participants should also be able to perform the tasks in the following Certara University courses:

- Intermediate PK/PD Modeling using Phoenix WinNonlin (On-Demand 200-OD
**or**Classroom 200-CL)

# Course Times

All full-day course times are 9 AM to 5 PM in the time zone of the venue.

It has come to our attention that some of the times are displaying in the time zone set in your local profile instead of the time of the venue. If you are not sure of the correct times, please contact info@certarauniversity.com

# Training material

- Welcome!
- Course Navigation
- Course Materials
- How to get help
- Questions
- Course Overview: Intermediate Population PKPD Modeling Using Phoenix NLME
- Lecture: Review of Basic Compartmental Models
- Quiz 1: Review of Compartmental Modeling
- Lecture: Statistical Aspects of Population Analysis, Part 1
- Lecture: Statistical Aspects of Population Analysis, Part 2
- Quiz 2: Statistical Aspects of Population Modeling
- Exercise 1: Pop PK Base Model
- Instructions for Exercise 1, Part 1: Exploratory Data Analysis
- Exercise 1: 1-Compartment IV Bolus Solution, Part 1: Exploratory Data Analysis
- Instructions for Exercise 1, Part 2: PK Compartment Modeling
- Exercise 1: 1-Compartment IV Bolus Solution, Part 2: Population Modeling & Comparison
- Lecture: Covariate Modeling, Part 1: Background
- Lecture: Covariate Modeling, Part 2: Plots & Comparisons
- Lecture: Covariate Modeling, Part3: Covariate Search Methods
- Quiz 3: Covariate Modeling
- Exercise 2: Covariate Modeling
- Exercise 2: Covariates Setup, Part 1
- Exercise 2: Covariates Setup, Part 2
- Instructions for Exercise 2: Population PK Covariate Search & Selection, Part 1: Exploratory Data Analysis
- Exercise 2: Population PK Covariate Search & Selection, Solution Part 1: Exploratory Data Analysis
- Instructions for Exercise 2: Population PK Covariate Search & Selection, Part 2: Fit a PK Compartment Model to the Individual Subject Data
- Exercise 2: Population PK Covariate Search & Selection, Solution Part 2: Fit a PK Compartment Model to the Individual Subject Data
- Instructions for Exercise 2: Population PK Covariate Search & Selection, Part 3: Fit a Population Base Model to the Data
- Exercise 2: Population PK Covariate Search & Selection, Solution Part 3: Fit a Base Population PK Model to the Data
- Instructions for Exercise 2: Population PK Covariate Search & Selection, Part 4: Perform a Stepwise Covariate Search
- Exercise 2: Population PK Covariate Search & Selection, Solution Part 4: Perform a Stepwise Covariate Search
- Instructions for Exercise 2: Population PK Covariate Search & Selection, Part 5: Re-run Population Model with Select Covariates and Compare Results
- Exercise 2: Population PK Covariate Search & Selection, Solution Part 5: Re-run Population Model with Selected Covariates, Compare Results
- Exercise 3: PK/PD Simulation with Continuous Data
- Exercise 3: PKPD Emax Model with Continuous data: Background & Setup
- Instructions for Exercise 3: PKPD Emax Model with Continuous data
- Exercise 3: PKPD Emax Model with Continuous Data: Solution
- Lecture: PK/PD Modeling Binary Outcomes; includes Background for Exercise 4
- Quiz 4: PD Modeling of Binary Responses
- Exercise 4: PK/PD Modeling Binary Outcomes
- Instructions for Exercise 4, Part 1: Exploratory Data Analysis
- Exercise 4: PKPD Modeling Binary Outcomes: Solution Part 1
- Instructions for Exercise 4, Part 2: Fit a Model to the Placebo Logits
- Exercise 4: PKPD Modeling Binary Outcomes: Solution Part 2
- Instructions for Exercise 4, Part 3: Derive Initial Estimates for Emax and E50, and Fit a Combined Logit Model to the Data for All Dose Groups
- Exercise 4: PKPD Modeling Binary Outcomes: Solution Part 3
- Instructions for Exercise 4, Part 4: Create Additional Plots to Compare the Treatment Groups
- Exercise 4: PKPD Modeling Binary Outcomes: Solution Part 4
- Lecture: Modeling Multinomial Categorical Responses, Part 1
- Lecture: Modeling Multinomial Categorical Responses, Part 2
- Quiz 5: Multinomial Categorical Responses
- Exercise 5: Modeling Multinomial Categorical Responses
- Instructions for Exercise 5, Part 1: Review the Exploratory Data Analysis
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 1
- Instructions for Exercise 5, Part 2: Use Data Tools to Get Initial Estimates for the PD Parameters
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 2
- Instructions for Exercise 5, Part 3: Construct the Base Multinomial Categorical Response Model
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 3
- Instructions for Exercise 5, Part 4: Refine the Multinomial Categorical Response Model
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 4
- Instructions for Exercise 5, Part 5: Construct the Base Multinomial Categorical Response Model
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 5
- Instructions for Exercise 5, Part 6: Create Probability Plots vs Time and vs Concentration
- Exercise 5: Modeling Multinomial Categorical Responses: Solution, Part 6
- Lecture: Covariate Styles and Options
- Lecture: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME
- Quiz 6: Covariate Styles and Options
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV)
- Instructions for Exercise 6, Part 1: Exploratory Data Analysis
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME: Solution, Part 1
- Instructions for Exercise 6, Part 2: Construct the Base Pop PK Structural Model
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME: Solution, Part 2
- Instructions for Exercise 6, Part 3: Add a model Comparer object, and Use Reset to allow IOV Modeling
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME: Solution, Part 3
- Instructions for Exercise 6, Part 4: Add Period as an Inter-Occasion Covariate (IOC)
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME: Solution, Part 4
- Instructions for Exercise 6, Part 5: Investigate Whether there is a Formulation Effect
- Exercise 6: Handling Crossover Studies and Inter-Occasion Variability (IOV) in PHX NLME: Solution, Part 5
- Lecture: Graphical Model Basics and Setup for Exercise 7: IV/SC & Bioavailability
- Exercise 7: Simultaneous Fitting of IV & SC data with Bioavailability Estimation
- Instructions for Exercise 7, Part 1: Exploratory Data Analysis
- Exercise 7: Graphical Model IV/SC & Bioavailability: Solution Part 1
- Instructions for Exercise 7, Part 2: Build a Graphical Model to fit IV/SC data for all Subjects
- Exercise 7: Graphical Model IV/SC & Bioavailability: Solution Part 2
- Instructions for Exercise 7, Part 3: Build a Graphical Model with XF Ratio to fit IV/SC data for All Subjects
- Exercise 7: Graphical Model IV/SC & Bioavailability: Solution Part 3
- Exercise 8: Multiple Absorption Routes
- Exercise 8: Multiple Absorption Routes: Setup
- Instructions for Exercise 8, Part 1: Construct the Graphical Model
- Exercise 8: Multiple Absorption Routes: Solution, Part 1
- Instructions for Exercise 8, Part 2: Review Results and Refine the Model
- Exercise 8: Multiple Absorption Routes: Solution, Part 2
- Exercise 9: Simultaneous Modeling of Parent Drug and Multiple Metabolites
- Exercise 9: Modeling Parent Drug and Multiple Metabolites: Setup
- Instructions for Exercise 9, Part 1: Exploratory Data Analysis
- Exercise 9: Modeling Parent Drug and Multiple Metabolites: Solution, Part 1
- Instructions for Exercise 9, Part 2: Build a Graphical Model to Simultaneously Fit Parent & Metabolite Data
- Exercise 9: Modeling Parent Drug and Multiple Metabolites: Solution, Part 2
- Instructions for Exercise 9, Part 3: Map Input Data, Specify Initial Estimates, and Run the Model
- Exercise 9: Modeling Parent Drug and Multiple Metabolites: Solution, Part 3
- Instructions for Exercise 9, Part 4: Modify the Graphical Model to have Reversible Metabolite Formation
- Exercise 9: Modeling Parent Drug and Multiple Metabolites: Solution, Part 4
- Quiz 7: Graphical Model Interface
- Lecture: Covariance Modeling and Interpreting the Omega Matrix (includes shrinkage)
- Quiz 8: Covariance Modeling and Interpreting the Omega Matrix
- Lecture: Modeling BLQ Data in Phoenix NLME
- Quiz 9: Modeling BLQ Data in Phoenix NLME
- Exercise 10: Modeling BLQ Data in Phoenix NLME
- Exercise 10: Analysis of BQL Concentrations: Setup
- Instructions for Exercise 10, Part 1: Use Data Tools to Perform BQL Replacements
- Exercise 10: Analysis of BQL Concentrations: Solution, Part 1
- Instructions for Exercise 10, Part 2: Model Data with BQL Set to Missing
- Exercise 10: Analysis of BQL Concentrations: Solution, Part 2
- Instructions for Exercise 10, Part 3: Model Data with BQL Set to LLOQ/2
- Exercise 10: Analysis of BQL Concentrations: Solution, Part 3
- Instructions for Exercise 10, Part 4: Model Data with BQL Replaced According to the M3 Method
- Exercise 10: Analysis of BQL Concentrations: Solution, Part 4
- Instructions for Exercise 10, Part 5: Compare the Best Models for Each BQL Replacement Method
- Exercise 10: Analysis of BQL Concentrations: Solution, Part 5
- Lecture: Visual Predictive Check (VPC) Options for Continuous Data
- Quiz 10: Visual Predictive Check (VPC) for Continuous Data
- Lecture: Ordinary Differential Equation (ODE) Solvers
- Lecture: NLME Run Mode Algorithms
- Quiz 11: Phoenix NLME Run Algorithms
- End of On-Demand Course Survey v2
- Thank you from Certara University Training