Description
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. Upon successful completion of this course, you will receive an e-badge as a Population Modeler using Phoenix NLME. This certification is valid for 3 years.
Pricing
Cost - $550 (Academia $275, Africa/India $150)
If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing. Note that you must register with an email address that is associated with an academic institution to get academic pricing.
If you work on a permanent basis in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing. You will need to provide proof that you are physically located in India to get the pricing.
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, 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.
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
Software Used
Phoenix WinNonlin and NLME™
A temporary (30-day) license is provided to subscribers of this course. When you are ready to start the practice exercises in this course, contact us to request your license.
Accessing the Course
After registering for this course, access your Dashboard. You will have access to this course for a period of 3 years after the purchase. The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course.
Course Length:
The course provides approximately 6 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.
Prerequisites
Fundamental knowledge of PK/PD concepts including basic compartmental models. Familiarity with the functionality of Phoenix WinNonlin software. Recommended background courses include:
Instructor
Nathan Teuscher is a leader in the pharmaceutical industry as a scientist, consultant, and teacher. Nathan has been teaching and training for over 15 years in the pharmaceutical industry, providing lectures in general pharmacokinetics to non-scientists, and specialized training in population pharmacokinetics and drug development to industry experts. Nathan also developed on-line training tools for Pharmacy students, intuitive software tools to aid in pharmacokinetic analysis, and a mobile application for calculation of pharmacokinetic parameters. His dynamic teaching style helps students understand the material and integrate the concepts into practice.
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion
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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.
e-Learning and Certifications
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