Description
June-July 2024
Cost - $550 (Academia $275, Africa/India $150)
Certification Course Description
In this course you will learn and get certified on the theory and application of non-compartmental analysis (NCA). NCA is used to characterize the kinetics of a compound without assuming a specific compartmental model. You will learn NCA methodology, how to perform NCA using Phoenix WinNonlin software, and how to interpret resulting pharmacokinetic parameters. This course is a comprehensive review of noncompartmental analysis of pharmacokinetic data and will cover the basics through the most complex areas of noncompartmental analysis. Upon successful completion of this course, you will receive an e-badge as an NCA Analyst using Phoenix WinNonlin. This certification is valid for 3 years.
Pricing
$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.
Course Format, Language and Dates
This course format is a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times. This will provide 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.
This course will be delivered in English.
This course will be offered in June and July, 2024. There will be six two-hour lecture/demo sessions. Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting June 4 and finishing on July 9. 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.
There are also five weekly office hour sessions, in which gives a more extended period for asking and answering questions. We have two options for people in different time zones:
- Office Hour 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).
- Office Hour 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.) We will offer the "Option B" office hours if there is sufficient interest among the students.
Practice Exercises
There are five practice exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis. 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.
Certification
This course includes a certification exam. To obtain credit for this course and earn a Certara Certification as an NCA Analyst using Phoenix WinNonlin version 8.4, candidates need to earn a passing score on the exam. The exam validates proficiency and competence with non-compartmental (NCA) pharmacokinetic (PK) analysis using Phoenix WinNonlin, with version 8.4. A certified NCA analyst can process data, perform exploratory data analysis, calculate NCA parameters, and report results for typical PK study designs in pre-clinical and clinical trials.
Exam Details
Software: There is no requirement to have the Phoenix WinNonlin™ software installed. The exam has interactive questions embedded that simulate the software. Those interactive questions are based on Phoenix WinNonlin 8.4.
Grading: To successfully earn the NCA Analyst 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 the test. The exam tests 80-90 questions that cover theoretical knowledge of NCA analysis on different types of study designs, and a practical section that evaluates software proficiency by performing tests related to NCA analysis, data processing, and reporting.
Time Limit: The exam is divided into 2 parts. There is a total time limit of 1 hr and 45 min to complete part 1 and 75 minutes 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 understand fundamentals of Pharmacokinetics, NCA theory, typical study designs that are often analyzed with NCA, and hands-on experience with Phoenix WinNonlin. Certification topics include:
- Basic Theory of PK and NCA
- Phoenix Interface
- Exploratory Data Analysis - Data Tools and Plots
- Performing NCA in Phoenix
- Processing NCA results
- Non-Parametric Superposition
- Study Designs
Prerequisites and Time Commitment
This course requires basic understanding of pharmacokinetics (recommended background: (103-OD) Fundamentals of Pharmacokinetics). Students are expected to be able to commit 5 hours a week to attend sessions and complete assignments.
Software
Phoenix WinNonlinTM
Participants are required to have a current license of Phoenix. A training license for the duration of the course can be purchased for an additional fee by contacting us.
Objectives
Session |
Topics |
|---|---|
Session 1 |
Course Overview
|
Session 2 |
Understanding Concentrations
|
Session 3 |
Half Life
|
Session 4 |
Using Cmax/AUC to make decisions
|
Bonus Recording |
Food Effects
|
Session 5 |
NCA Steady-State
|
Session 6 |
NCA Data Presentation
|
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion
Note: the launching of a new Certara website makes it necessary to publish a new versions of these Terms and Conditions for Certara University. The Certara "Privacy" link below has a new URL. The rest of the terms are unchanged from the previous version.
User Accounts and Registrations
The email address used for your user login must be an individual account. No sharing of user accounts between multiple individuals is allowed. Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.
Course Materials
As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials.
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
There are no refunds for e-Learning courses or certifications. Course expiration dates can be found on your Dashboard.
Electronic Communication
We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions. We will also send email for general announcements about the site. You can opt out of these emails if you wish (located in your profile).
Details
Full terms and conditions applicable to this LMS are available at the Certara Legal web page.
Updated: Certara is committed to protecting your privacy. Details of our privacy policy are available at the Privacy web page.
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