Description
April-May 2025
Cost - $550 (Academia $275, Africa/India $150)
Certification Course Description
The objective of this course is to train Phoenix WinNonlin users 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.
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 as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times. This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel. Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course. You will have access to the recordings for 3 months following the last session of the course.
This course will be delivered in English.
Lecture/Demo Sessions
Live Zoom sessions will occur in April and May, 2025. There will be six two-hour lecture/demo sessions. Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 15 April and finishing on 20 May. We will record sessions and post the recordings for those who are unable to attend live. You will have access to the recordings for 3 months following the last session of the course.
Self-Paced Exercises
There are five self-paced exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis. You do not need to run Phoenix to do the self-paced exercises, because everything is contained in the module. Each practice exercise contains a quiz that you must pass with at least a 60% score, although you can repeat each quiz as many times as you need to pass it.
Hands-on Exercise Sessions
There are also five weekly "Hands-on Exercise" Zoom sessions that give you the opportunity to carry out the same analysis as in that week's "Self-Paced Exercise", working collectively in Phoenix. You will be divided into small groups, and will work together on the exercise. At least one in each group will need to have Phoenix running on their computer and have an active WinNonlin license.
- Hands On Exercise Session Option A is offered at times most convenient for participants in the Americas, Europe, and Africa. They are on Fridays at 11 AM New York (GMT-4).
- Hands On Exercise Session Option B is offered at times most convenient for participants in Asia/Pacific. They are on Tuesdays at 2 PM Brisbane (GMT+10). (FYI, 2 PM Tuesday in Brisbane is late Monday evening in New York.)
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
Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments.
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
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Lecture 5 - Special Topics:
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Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion
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User Accounts and Registrations
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Course Materials
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Cancellation Policy
Classroom Courses
Certara retains the right to cancel sessions, if 30 calendar days before the first day of class, there are fewer than five students enrolled. Participants should wait to book nonrefundable travel until they receive confirmation from Certara that a class has sufficient registrations to proceed.
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.
If you cannot attend the session for which you have enrolled, you can (1) choose a different session of the same course, (2) have another person attend in your place, or (3) you may be able to get a full or partial refund, based on the number of days prior to the session, as shown in the table.
| 1-30 Calendar Days | 0% Refund |
| 31-59 Calendar Days | 50% Refund |
| 60 Calendar Days or More | 100% Refund |
Live Online Courses
There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
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Details
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