Description
April-May 2026
Cost - $550 (Academia $275, Africa/India $150)
Certification Course Overview
This course trains Phoenix WinNonlin users to perform population PK modeling using Phoenix NLME. Population PK/PD modeling is increasingly used in regulatory submissions due to its ability to handle sparse or pooled data and quantify variability in PK parameters across individuals.
Through hands-on exercises, learners will build population PK models, incorporate covariates to explain variability, and validate models using bootstrap and VPC. The course also covers essential theory to support effective model development and interpretation.
Course Structure
Total Duration: 18 hours of live sessions + 5 self-paced exercises
Live Components:
- 6 × 2-hour lecture/demo sessions
- 6 × 1-hour hands-on group exercises
Access: Recordings available for 3 months post-course
Prerequisites
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
Live Sessions
- Lecture/Demo: Tuesdays, April 21 – May 26 (10AM–12PM ET)
- Hands-on Exercises: Fridays, April 24 – May 29 (11AM–12PM ET)
Who Should Attend
This course is ideal for:
- Scientists and analysts working in pharmacokinetics, pharmacodynamics, or pharmacometrics
- Clinical pharmacologists seeking to learn population PK/PD modeling skills
- Professionals using Phoenix WinNonlin for drug development or regulatory submissions
- Academic researchers and graduate students who work with drug development
- Anyone who has completed the PK/PD modeling certification course and wants to develop skills in population modeling and simulation
Certification Exam
Software: No installation required; interactive simulation based on Phoenix WinNonlin 8.4/8.5
Structure: Two parts
- Part 1: 1 hr 45 min
- Part 2: 75 min
Content: 80–90 questions covering theory and practical application
Passing Score: 75% on both parts
Attempts: Two included
Topics: 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.
Time Commitment
Estimated 5 hours/week for live sessions and assignments, plus up to 6 hours for the certification exam
Software Requirements
Phoenix WinNonlinTM and Phoenix NLME licenses are both required
Participants are expected to have a current license to Phoenix WinNonlin and 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.
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.
Session Topics
Week 1 main session: course logistics, quick overview of population PK/PD methodology, overview of Phoenix, exploratory data analysis, overview of compartmental models, Phoenix model object, model assessment.
Week 1 hands-on session: perform exploratory data analysis, create individual models, compare models.
Week 2 main session: overview of 2 stage approach, structural model building, comparing models, residual error models, examine covariate relationships, naïve pool approach, FOCE-ELS.
Week 2 hands-on session: create phase 1 pop model with covariates, add covariates, set run options and update model, evaluate model fit, examine covariate relationships, test if removing time lag improves model, compare population models.
Week 3 main session: review of lecture 1 and demonstration with phoenix NLME, shrinkage, covariates effects, the Phoenix Model Comparer.
Week 3 hands-on session: create phase 3 model with covariates, evaluate phase 3 model and revise model, examine covariate relationships, conduct covariate search, create covariate model.
Week 4 main session: demonstration with Phoenix NLME, covariance analysis, model qualification: bootstrap/VPC, external validation, reporting population models.
Week 4 hands-on session: explore covariance models, conduct VPC on models, bootstrap (if time permits).
Week 5 main session: model simulation, visual predictive check.
Week 5 hands-on session: population simulations, determine dosing regimen for sub-groups.
Week 6 main session: sequential PK/PD, plots within Phoenix using R-script, Phoenix BQL options, Phoenix model run options, additional population engines.
Week 6 hands-on session: TBA
Objectives
By the end of this course, participants will be able to:
- Explain the principles of population PK/PD modeling and its applications in drug development and regulatory submissions.
- Perform exploratory data analysis and prepare datasets for population modeling using Phoenix WinNonlin and Phoenix NLME.
- Build and refine population PK models, including model structure, residual error, covariance, and covariate effects.
- Evaluate model performance using diagnostic plots, shrinkage, and model comparison tools.
- Incorporate covariates to quantify and explain inter-individual variability in PK parameters.
- Conduct model validation using bootstrap methods and visual predictive checks (VPC).
- Simulate population models to explore dosing strategies and predict outcomes for subgroups.
- Prepare and present population modeling results in a format suitable for regulatory or scientific communication.
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion
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Cancellation Policy
Classroom Courses
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If a scheduled class is cancelled, Certara will notify enrolled students at least thirty calendar days before the first day of the scheduled class and the full cost of the course would be refunded. Certara will not be responsible for any airfare, accommodation or other costs incurred by registrants in the event a course is cancelled for any reason. If Certara cancels a course within 30 days for any unforeseen reason a full refund will be issued and airfare exchange fees may be refunded.
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Notification of Cancellation by Participant Amount of Refund| 1-30 Calendar Days | 0% Refund |
| 31-59 Calendar Days | 50% Refund |
| 60 Calendar Days or More | 100% Refund |
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