May 8 - 10, 2024
This introductory population PK training workshop has been designed to provide the necessary information to successfully implement population pharmacokinetic methodology in a drug development program and to provide the foundation for understanding the basics of NONMEM coding and interpretation of NONMEM output.
The material is structured to impart both the theoretical and practical aspects of the population approach and is versatile so that participants with diverse backgrounds and areas of expertise may benefit. No prior experience with NONMEM is assumed or required. Examples of the use of population PK studies in drug development programs will be presented to provide specific details of various implementations and better illustrate essential aspects of population PK methods. Participants will gain an appreciation for the essentials of accurate and sufficient data collection and learn how to proactively plan in order to maximize study effectiveness. Throughout the workshop, the presenters will provide examples from their experience to inform best practices for implementation and avoiding problems. Emphasis will be placed on compliance with the FDA’s Guidance for Industry on Population PK and the EMA’s Guideline on Reporting the Results of Population PK Analyses.
The workshop content will be provided as a combination of live lectures, review of data, code, and modeling results, plus hands‐on individual and small group exercises. Participants will be able to practice coding control streams, running various models, and evaluating the results. A thorough examination of an example dataset, from development of the structural and statistical models through covariate analysis will be covered. To ease the learning curve and ensure that participants are up and running with NONMEM very quickly, the KIWI™ Pharmacometric Communication Platform will be used in conjunction with NONMEM. KIWI is useful in facilitating code writing, finding errors, comparing output from different models, and generating point‐and‐click model diagnostics.
Following the workshop, the participant should be able to:
The workshop is organized and taught by experienced pharmacometricians from the Clinical Pharmacology & Pharmacometrics Business Unit (formerly the Cognigen division) of Simulations Plus, Inc., also affiliated with the University at Buffalo. Simulations Plus, Inc., has been providing clinical pharmacology and pharmacometric consulting services, including population PK/PD modeling and simulation to the global pharmaceutical industry for over 25 years to generate and communicate the knowledge required for time‐sensitive decision‐making and regulatory review. In addition to other instructors, the workshop will feature Luann Phillips, as well as Jill Fiedler‐Kelly, co‐author of Introduction to Population Pharmacokinetic/Pharmacodynamic Analysis with Nonlinear Mixed Effects Models (JohnWiley & Sons Inc., 2014).
|08:35-08:45||Welcome and Introduction to the Workshop|
|08:45-09:45||The Population Approach in Drug Development|
|09:45-10:20||Population Modeling Basics|
|10:40-12:45||NONMEM® Terminology & Classical Estimation Methods in NONMEM® |
|01:45-03:15||Brief Overview of the NONMEM® Program and Writing an NM-TRAN Control Stream|
|03:35-04:05||NM-TRAN Lecture (cont’d)|
|04:05-05:20||NONMEM® Dataset Structure|
|05:20-05:30||Exercise: Writing Control Streams and Diagnosing Dataset Problems|
|08:30-09:15||Discuss Control Stream and Dataset Exercise|
|09:15-09:50||Exploratory Data Analysis|
|09:50-10:35||Running NONMEM® and Interpreting the Output |
|10:55-11:25||Exercise: Introduction to KIWI|
|11:25-11:35||Data Review: Introduction to the Example Dataset and Exploratory Data Analysis|
|11:35-12:30||Exercise: Developing a Base Structural Model|
|01:30-02:00||Base Structural Model Exercise (cont’d)|
|02:00-02:10||Data Review: Base Model|
|02:10-02:45||Model Diagnostic Plots|
|03:05-03:35||Model Selection and Covariate Evaluation – Part 1: The Covariate Assessment Process|
|03:35-04:25||Covariate Evaluation–Part 2: Functional Forms|
|04:25-04:40||Data Review: Introduction to Covariate Analysis and Coding Issues|
|04:40-05:30||Exercise: Forward Selection of Covariate Effects|
|08:30 -09:00||Forward Selection Exercise (cont’d)|
|09:00-09:40||Data Review: Forward Selection Results and Multivariable Model Checking|
|09:40-10:20||Exercise: Backward Elimination of Covariate Effects|
|10:40-11:20||Backward Elimination Exercise/Model Wrap-Up (cont’d)|
|11:20-12:00||Applications of Bayesian Parameter Estimation|
|01:00-02:50||Diagnosing Errors, Model Checking, Model Refinement, and Model Evaluation Techniques|
|02:50-03:00||Data Review: Backward Elim & Model Refinement|
|03:20-04:20||Pharmacometric Analysis Planning and Population PK/PD Modeling and Simulation|
|04:20-04:30||Wrap-up and Final Q & A|
Masks are optional for in-person classes and hands-on training. The University at Buffalo, Simulations Plus, Inc., The Niagara Falls Convention Center (NFCC), and hotels are not liable for any COVID-19 related issues. Proper protocols must be followed if implemented. Full vaccination is highly recommended. Rigorous cleaning protocols are performed.
The course will be held in person at:
The Conference & Event Center Niagara Falls
101 Old Falls Street
Niagara Falls, NY 14303
Phone: (716) 278-2100
Fax: (716) 278-0008
The Center is 28 minutes from Buffalo Niagara International Airport.
Several nearby hotels within walking distance are available. Please book directly as soon as registered for this course. Possible hotels include:
An evening dinner outing, sponsored by Simulations Plus, Inc., will be offered on Wednesday, May 8, 2024.
Laptop computers equipped with a web browser are required to fully participate in hands-on exercises. Access to NONMEM and KIWI will be provided for the duration of the course.
The fee is $2,800. A graduate student rate of $1,400 is available for up to 5 participants. The registration fee includes access to the course documentation, code examples, and a copy of the textbook, Introduction to Population Pharmacokinetic/Pharmacodynamic Analysis with Nonlinear Mixed Effects Models by Owen and Fiedler-Kelly (John Wiley & Sons Inc., 2014). Continental breakfasts, lunches and break-time refreshments during the course are included. No walk-ins accepted.
Mastercard, Visa, American Express, and Discover card payments will be accepted.
Cancellations with a full refund may be made until March 11, 2024. No refund is possible on cancellations received after this date. Substitutions may be made at any time.
Contact UB course secretary Suzette Mis at (716) 645-4834 or email@example.com if you need assistance.