Session 1: An Introductory Workshop in Population PK Data Analysis with NONMEM® (In Person)

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:

1. Understand the conceptual basis and rationale for the population approach to data analysis, its benefits and advantages, including where and when population methods may be optimally applied during drug development
2. Write, execute, and de-bug basic NONMEM® control streams for structural PK models
3. Outline the requirements and understand the format for basic NONMEM® datasets
4. Understand the importance of exploratory data analysis (EDA) and the interpretation of standard goodness-of-fit diagnostic plots
5. Perform covariate analyses to evaluate determinants of variability by understanding, identifying, and coding basic functional forms for covariate-parameter relationships
6. Understand the basis for model selection strategies and discriminate between candidate models on the basis of both quantitative and qualitative factors
7. Understand and interpret NONMEM® output, including error messages, and have insight into model refinement issues

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).

The course will be held in person at:
The Niagara Falls Convention Center (NFCC)
101 Old Falls Street
Niagara Falls, NY 14303
USA
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:

• Sheraton Niagara Falls
• Quality Hotel & Suites At The Falls
• Hyatt Place Niagara Falls
• Wingate by Wyndham Niagara Falls
• Comfort Inn The Pointe
• The Cadence
• Seneca Niagara Resort & Casino
• Holiday Inn Niagara Falls-Scenic Downtown
• The Giacomo

An evening dinner outing, sponsored by Simulations Plus, Inc., will be offered on Wednesday, May 7, 2025.

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 (registered MS and PhD) 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 17, 2025. 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 mis@buffalo.edu if you need assistance.