(105-OD) Noncompartmental Data Analysis

Content
36 modules

Difficulty
Basic

Rating

Course Length
4 hours

Instructor
Thomas Jones

Price
$150 - 299

Description

Cost - $299 (Academia $150) - [Conceptual Course]

This course is a comprehensive overview of noncompartmental analysis of pharmacokinetic data. This course will cover the basics through the most complex areas of noncompartmental analysis. The course includes video presentations, spreadsheet-based problems, and guided answers. Anyone with interest in pharmacokinetics, drug disposition, drug metabolism should take this course. In addition, this course is an excellent primer for pharmacists, physicians, and other healthcare professions that work with pharmaceutical agents. In addition, clinical trial managers and clinical research associates would benefit from this course.

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.

Software Used

Using a spreadsheet (such as Microsoft Excel™) is recommended for doing the calculations.

This course teaches NCA concepts and doesn't include the use of Phoenix WinNonlin.  To learn how to use Phoenix WinNonlin to do NCA, see courses (122-LO) or (100-OD).

Accessing the Course

After registering for this course, login to certarauniversity.com and 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 2 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 4 hours to complete, including time to perform the tasks in a spreadsheet program.

Prerequisites

None

Instructor

Tom Jones

Tom Jones has helped thousands of scientists become proficient with using Certara software in their research in the pharmaceutical industry. After completing his Ph.D. in analytical chemistry, he spent several years as an assistant professor, during which time he applied molecular modeling to teaching and research in chemistry, and then came to Certara, where for 18 years he has applied his passion for teaching scientific software applications. At first Tom was focused exclusively on molecular modeling applications in drug discovery and later broadened his expertise to include informatics and PK/PD modeling and analysis. He has created many training manuals, and you may very well have heard his voice in one of the numerous webinars and video demos he has created to help scientists become more proficient with Certara software.

Objectives

Observed Parameters

  •     Understanding Concentration Data and Observed Parameters
  •     Effect of Study Design on Observed Parameters

Half-Life

  •     Definitions and Uses
  •     Calculating Half-Life from Plasma Data
  •     Calculating Half-Life from Urine Data

AUC

  •     Definition and Interpolation
  •     Extrapolation to Infinity
  •     Using AUC to Make Decisions

Clearance

  •     Definition and Calculation
  •     Extraction Ratio, Intrinsic Clearance, and Changes in Clearance

Statistical Moments

  •     Definition and Mean Residence Time
  •     Mean Input Time and Area Under the Moment Curve (AUMC)

Presenting PK Results: Observations to Conclusions
Bioequivalence: Definition, Calculation, Equivalence Margins, and Reporting
Study Design Considerations

  •     Overview of Study Design Principles
  •     Hypothesis to Endpoints
  •     Population, Schedule and Procedures

Limitations of NCA

Certificate

By completing/passing this course, you will attain the certificate Certificate of Completion

1
Welcome!
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Course Files (Datasets and Solutions)
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Course Overview
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Observed Parameters, Part 1: Understanding Concentration Data and Observed Parameters
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Review of Observed Parameters Part 1
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Observed Parameters, Part 2: Effect of Study Design on Observed Parameters
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Review of Observed Parameters Part 2
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Half-Life, Part 1: Definition and Uses
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Half Life, Part 2: Calculating Half-Life from Plasma Data
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Exercise 1: Half-Life Calculation
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Half Life, Part 3: Calculating Half-Life from Urine Data
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AUC, Part 1: Definition and Interpolation
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Exercise 2: AUC Calculation
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AUC, Part 2: Extrapolation to Infinity
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Exercise 3: Extrapolation to Infinity
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AUC, Part 3: Using AUC to Make Decisions
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Clearance, Part 1: Definition and Calculation
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Clearance, Part 2: Extraction Ratio, Intrinsic Clearance and Changes in Clearance
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Review of Clearance
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Statistical Moments, Part 1: Definition and Mean Residence Time
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Statistical Moments, Part 2: Mean Input Time and Area Under the Moment Curve (AUMC)
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Exercise 4: Calculate AUMC
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Review of Statistical Moments
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Presenting PK Results: Observations to Conclusions
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Review of Data Presentation
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Bioequivalence: Definition, Calculation, Equivalence margins, and Reporting
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Review of Bioequivalence
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Study Design Considerations, Part 1: Overview of Study Design Principles
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Study Design Considerations, Part 2: Hypothesis to Endpoints
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Study Design Considerations, Part 3: Population, Schedule and Procedures
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Review of Study Design Considerations
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Limitations of NCA
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Review of NCA Limitations
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Course Summary
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Congratulations!
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Course Feedback Survey
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Added 3 months ago, by Anonymous
Very useful course, you can learn not only about NCA but gives tips about data and results presentation and study design

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