Description
Cost - $550 (Academia $275, Africa/India $150)
Certification Course Description
The objective of this course is to learn how to perform population PK using Phoenix NLME. Population PK/PD modeling is being used increasingly in regulatory submissions. Population PK modeling can handle sparse data and also data combined from several studies. The population approach estimates the variability between subjects in the PK parameters and can help you understand potential sources of PK variability.
Through a series of practical exercises, learners will create population PK models, add covariates to models to help explain and quantify individual variation, and validate their models using bootstrap and VPC. Learners will become familiar with the theory necessary to make effective use of population modeling.
You will have access to this course for 3 years. No manual or printed material is associated with this course.
Pricing
Cost - $550 (Academia $275, Africa/India $150)
Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.
If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type.
Course Format, Language and Dates
This course format is 'e-learning', which means that you can take the course at your own pace. The course materials include recorded lectures and interactive tasks. You will be asked to carry out tasks in a simulation of Phoenix. You will interact by clicking and entering text. Although it will look and feel like you are interacting with Phoenix, the simulation is not a real instance of Phoenix. It can only go through the task that was assigned.
This course audio is in English, with closed captions that can be turned on or off.
Certification Exam
This course includes a certification exam. To obtain credit for this course and earn a Certara Certification as a PK/PD Modeler using Phoenix WinNonlin version 8.4 or 8.5, candidates need to earn a passing score on the exam. The exam validates proficiency and competence with Maximum Likelihood Models in Phoenix WinNonlin.
Exam Details
Software: There is no requirement to have the Phoenix NLME™ software installed to take the exam. The exam has interactive questions embedded that simulate the software. Those interactive questions are based on Phoenix NLME 8.4 or 8.5.
Grading: To successfully earn the Population Modeler certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing each part of the test. The exam tests 80-90 questions that cover theoretical knowledge of population modeling, and a practical section that evaluates software proficiency with population models in Phoenix NLME.
Time Limit: The exam is divided into 2 parts. There is a time limit of 1hr 45min to complete part 1, and 1hr 15min to complete part 2 of the exam. The clock starts counting when the user clicks on 'Start Exam' in each part.
Exam Content: Successful candidates should be able to use Phoenix NLME to create population models, including covariate analysis, covariance analysis, model validation, and simulation. Exam topics include:
- Population PK Theory
- Data Preparation
- Exploratory Data Analysis
- Model Development
- Covariate Models
- Covariance Models
- Model Comparisons
- Model Validation (VPC and Bootstrap)
- Reporting Population Model Results
Prerequisites and Time Commitment
Fundamental knowledge of PK/PD concepts including basic compartmental models. Familiarity with the functionality of Phoenix WinNonlin software. Recommended background courses include:
- (103-OD) Fundamentals of Pharmacokinetics
- either (122-LIVE-CERT) or (122-OD-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course
- either (123-LIVE-CERT) or (123-OD-CERT) Phoenix WinNonlin (Part 2) PK/PD Modeling Certification Course
The course provides approximately 6.5 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 24+ hours to complete, including time to perform the tasks in Phoenix.
Software
Phoenix WinNonlin and NLME
Participants are expected to have current licenses for both Phoenix WinNonlin and Phoenix NLME. If a 60-day software license is needed one can be provided for an additional fee. Contact us if you want to order a license.
Objectives
Learning Objectives
- Prepare and format pharmacokinetic data sets for population modeling in Phoenix by applying appropriate data cleaning and structuring techniques.
- Explain and apply key concepts of pharmacokinetic modeling, including compartmental models, parameter estimation, and goodness-of-fit assessment, to interpret model outputs in Phoenix.
- Construct individual pharmacokinetic models in Phoenix using a provided time–concentration dataset, by selecting appropriate structural models, estimating parameters, and validating model fit.
- Describe the fundamental principles of population pharmacokinetic modeling and identify key applications, including variability analysis and covariate effects, within the context of drug development.
- Develop a base population pharmacokinetic model in Phoenix using a prepared dataset, by specifying structural model parameters, estimating inter-individual variability, and evaluating model fit without incorporating covariates.
- Explain the role of covariates in population pharmacokinetic models, distinguish between categorical and continuous covariates, and identify examples of each that could influence drug exposure and variability.
- Build a population pharmacokinetic model in Phoenix by performing a stepwise covariate search, adding and removing covariates based on statistical criteria, and evaluating the impact on model fit and parameter variability.
- Construct covariance structures in population pharmacokinetic models using Phoenix by implementing diagonal, full-block, and partial-block omega matrices, and compare their impact on inter-individual variability and model stability.
- Validate population pharmacokinetic models in Phoenix by generating and interpreting Visual Predictive Checks (VPC), assessing predictive performance and identifying potential model misspecifications.
- Validate a population pharmacokinetic model in Phoenix by performing a bootstrap analysis, interpreting confidence intervals for parameter estimates, and assessing model stability.
- Generate population pharmacokinetic simulations in Phoenix to evaluate drug exposure across sub-groups (e.g., age, body weight), analyze differences in exposure, and propose potential dose adjustments for specific populations based on simulation results.
- Select and apply appropriate population model run options in Phoenix, including estimation algorithms, parallel processing settings, and ODE solvers for stiff systems, to optimize model performance and ensure numerical stability.
- Perform sequential pharmacokinetic/pharmacodynamic (PK/PD) model fitting in Phoenix by first estimating PK parameters from concentration–time data, then using these estimates to fit PD models, and evaluate the adequacy of the combined PK/PD model.
- Apply EMA guidance on population pharmacokinetic modeling to prepare a comprehensive final modeling report in Phoenix, incorporating required sections (e.g., objectives, methods, results, diagnostics, conclusions) and critically evaluate literature examples to ensure regulatory compliance and best practices.
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion
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Classroom Courses
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Notification of Cancellation by Participant Amount of Refund| 1-30 Calendar Days | 0% Refund |
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