October 27th - 31st, 2025 (Virtual) - At the completion of the workshop you will have an understanding of the inputs and interactions that exist among the various mechanistic phenomena affecting drug dissolution, absorption, distribution, metabolism and elimination. You will be able to use GastroPlus to generate robust PBPK models integrating compound properties, data and mechanisms and to apply them to scenarios involving special populations and Drug Drug Interactions. PBPK Autumn School: From Basics to Practical Application with GastroPlus®  Introduce the essential concepts for building PBPK models and explore the primary FDA-labeled applications of PBPK modeling. Free Online Training | October 27 - 31, 2025 Why This Training Matters The PBPK Autumn School is designed for modelers willing to learn the basics of PBPK modeling and to apply this learning to take their modeling further using GastroPlus. Over five intensive sessions you'll learn how to estimate the distribution and elimination of an API following intravenous administration, setup basic parameters influencing absorption, and use your validated PBPK model to extrapolate the pharmacokinetics of an API in special populations and to predict Drug-Drug interactions. More than a software tutorial, this course gives you the framework, skills and mindset to support First-in-Human applications, and additional Clinical Pharmacology regulatory decisions.  You'll see not only "how" to use novel GastroPlus features but "why" they must be utilized in a certain order, to support your PBPK model endeavor. With hands-on exercises, live expert guidance, and a free temporary GastroPlus license, you'll be able to experiment directly on your own projects and bring back immediately usable workflows to your team. How You Will Learn Five Live online lectures led by GastroPlus experts each day Learn directly from the people who develop and use the tools at the highest level, gaining not just instructions but insight into best practices, strategies, and real-world applications. Two identical 2 h sessions per day - choose the time zone that fits you - and video recordings Ensure you can participate live, ask questions, and learn at your best time without missing content or interaction. Interactive Q&A chat during each session with GastroPlus experts Get immediate answers to your modeling challenges and clarify concepts as you learn, turning lectures into active problem-solving sessions. Hands-on exercises to reinforce new skills Apply what you've just learned in a guided environment, moving from theory to practice and cementing your ability to replicate these workflows later. Comprehensive materials: presentations, datasets, and GastroPlus projects Build your own reference library to revisit concepts, test workflows on your own time, and accelerate mastery after the course. Certificate of attendance Demonstrate your training in advanced PBPK and GastroPlus to colleagues, supervisors, or regulatory bodies. Free temporary license for GastroPlus Use the same tools you're learning on your own projects, experiment with advanced features, and get immediate help from experts during the course - turning learning into direct project impact. Skills and Insights You'll Gain Session 1: Practical Guide to Define API Distribution Using PBPK Models Session 2: Clearance IVIVE Using PBPK Models Session 3: Practical PBPK Considerations for Oral Models Session 4: PBPK Models for Special Populations Session 5: PBPK Models for Drug Drug Interactions Read more

MonolixSuite™ Autumn School: Advanced Modeling in Pharmacometrics Beyond Routine Workflows: Expand Your Skills in Advanced Modeling, Automation and Reporting Free Online Training | October 27 - 31, 2025 Why This Training Matters The MonolixSuite™ Advanced Autumn School is designed for pharmacometricians who already know Monolix basics and want to go further. Over five intensive sessions you'll learn how to handle complex PK/PD and develop QSP models, work confidently with non-continuous data, and automate your workflows to save time and reduce errors. More then a software tutorial, this course gives you the framework, skills and mindset to turn routine analyses into insights that support dose selection, trial designs and regulatory decisions.  You'll see not only "how" to use advanced Monolix features but "why" certain approaches work, and how to apply them to real-world challenges. With hands-on exercises, live expert guidance, and a free temporary MonolixSuite™ license, you'll be able to experiment directly on your own projects and bring back immediately usable workflows to your team.  How You Will Learn Five Live online lectures led by MonolixSuite™ experts each day Learn directly from the people who develop and use the tools at the highest level, gaining not just instructions but insight into best practices, strategies, and real-world applications. Two identical 1.5 h sessions per day - choose the time zone that fits you - and video recordings Ensure you can participate live, ask questions, and learn at your best time without missing content or interaction. Interactive Q&A chat during each session with MonolixSuite™ experts Get immediate answers to your modeling challenges and clarify concepts as you learn, turning lectures into active problem-solving sessions. Hands-on exercises to reinforce new skills Apply what you've just learned in a guided environment, moving from theory to practice and cementing your ability to replicate these workflows later. Comprehensive materials: presentations, datasets, Monolix projects, and video recordings Build your own reference library to revisit concepts, test workflows on your own time, and accelerate mastery after the course. Certificate of attendance Demonstrate your training in advanced pharmacometrics and MonolixSuite to colleagues, supervisors, or regulatory bodies. Free temporary license for all MonolixSuite™ applications Use the same tools you're learning on your own projects, experiment with advanced features, and get immediate help from experts during the course - turning learning into direct project impact. Skills and Insights You'll Gain Session 1: Building the Skills for Advanced PK/PD: Model Selection, Diagnostics and Strategy In this first session, you'll move beyond routine PK/PD workflows and learn to think like an advanced modeler. Through a step-by-step complex case study, you'll practice selecting the right models, apply diagnostic and visualization tools effectively, and perform sensitivity analyses to ensure predictive accuracy. By the end, you'll be able to confidently tackle challenging PK/PD datasets, and extract reliable insights that support model development decisions. Session 2: Inside the Calculation Engine: Understanding and Controlling Monolix Algorithms Monolix has as an easy-to-use interface, but behind every click are powerful algorithms that shape your results. In this session, you'll uncover how these methods work, how their settings influence outcomes, and why understanding them is essential for creliable, efficient modeling. By the end, you'll be able to choose and adjust algorithms with confidence, defend your modeling decisions to colleagues and regulators, and extract more reliable insights from your analyses. Session 3: Beyond Continuous Outcomes: Modeling Time-to-Event, Count and Categorical Data in Monolix Continuous outcomes are only part of the story - data in drug development comes also as time-to-event, counts, or categories. In this session, you'll learn how Monolix handles these non-continuous data types, from dataset structure and dedicated diagnostic plots to model coding in Mlxtran. Using real case studies, you'll practice building and interpreting survival, count, and categorical models, including covariate effects and event probability predictions. Session 4: Turning Repetition into Strategy: Automation and Standardization of Workflows in R Monolix's graphical interface is ideal for exploring and developing models, but it also means repeating the same clicks across projects. Few users realize how much can be automated to create reproducible, transferable workflows, reduce errors, and accelerate analyses. In this session, you'll learn to streamline your work with plots presets, lixoftConnectors in R, and integrated report generation. We'll show how to create, share and apply custom plot settings, script Monolix and Simulx workflows in R, and generate both exploratory and regulatory-style reports using Quarto. By the end, you'll know how to turn automation into a strategic advantage rather than a routine technical task. Session 5: From PK/PD to Systems Thinking: Applying QSP Modeling in Monolix While PK/PD and QSP models both use ODEs, QSP goes further by linking biological pathways, mechanisms and diverse data sources to address system-level questions beyond the scope of standard PK/PD. In this session, we'll walk through the development and calibration of a full QSP model using a real FAAH inhibitor example. You'll see how in vitro, preclinical, and clinical data come together into a single mechanistic framework, how model equations are formulated, and how sensitivity and uncertainty analyses reveal influential parameters and test key assumptions. By the end, you'll understand the principles and workflow of QSP modeling in Monolix, see how it connects to traditional PK/PD approaches, and gain the insight needed to start applying these methods in your own projects or collaborations. Read more

November 6th, 2025 - This hands-on training course will introduce participants to the basic use and new features of RENAsym v2A, for both new and experienced users. Guided exercises will walk users through the usage of RENAsym to predict drug-induced kidney injury, and users will also be introduced to improvements made for RENAsym v2A. Attendees can request a complimentary, 2-week trial of RENAsym. Please fill out a request form located here. Read more

November 4th, 2025 - This hands-on training course introduces participants to the latest features and sub-models in DILIsym® version 11, designed to support both new and experienced users. Through guided exercises, attendees will gain practical experience navigating enhancements in mechanistic modeling of drug-induced liver injury. While prior completion of the 2023 DILIsym Crash Course is recommended for foundational context, it is not required to participate. Attendees can request a complimentary 2-week trial of DILIsym. Please fill out a request form located here.   Read more

November 9th, 2025 (In Person) - This complimentary Immersive Experience at AAPS will jump start you into the new features of GPX.2! You’ll get a first look at game-changing new science and functionality that will revolutionize your PBPK/PBBM modeling. This is your chance to use the latest PBPK/PBBM software - register now to save your seat!   Course Description: This half-day session will introduce participants to the new GastroPlus® 10.2 (GPX.2™) platform and its application to drug development scenarios. Leveraging mechanistic physiologically based pharmacokinetic (PBPK) and biopharmaceutics modeling (PBBM) approaches, the session will highlight how the integrated AssessmentsPlus™ and Distribution Dashboard, alongside Orchestrator can be applied to accelerate baseline model development, and how the integrated P-PSD™ module can be used to predict formulation outcomes. Through live demonstrations and guided exercises, attendees will explore how GPX.2 enables faster, more robust decision-making for clinical pharmacology and biopharmaceutics applications.   Who should attend? This session is designed for students, scientists and regulatory professionals working in formulation development, clinical pharmacology, biopharmaceutics, and modeling & simulation who are looking to harness GPX.2 innovations to accelerate development timelines, strengthen predictive accuracy, and reduce reliance on costly clinical studies.   *Light refreshments provided   Read more

On Demand | Learn how to leverage DDDPlus™ to simulate and predict dissolution behavior across a variety of formulation scenarios. This course covers key concepts including solubility versus pH, particle size effects, biorelevant solubility, precipitation modeling, extended-release formulations, surfactant media dissolution, and the role of disintegration or solubilizer constants—empowering scientists to use in silico tools for optimizing drug product performance. It is required to have access to DDDPlus™, and a GastroPlus® license is recommended for this course. To request an evaluation of the software please reach out to [email protected] Read more