Model-informed Drug Development Intensive Interactive Courses

A Short presentation from Professor Amin Rostami, Certara SVP of R&D and Chief Scientific Officer.  Read more

This on-demand workshop focusses on in silico-based mechanistic prediction of dermal drug absorption. The details of the models used to mechanistically predict skin absorption after topical application will be explained. In addition examples of using mechanistic physiologically-based in vitro-in vivo correlation (IVIVCs), and virtual bioequivalence (VBE) concepts will be presented. Course Structure Duration: Accessible for one month post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by completing the course.  Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and tutors avaibale during office hours to suit you.  No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Prerequisites: Delegates should be familiar with the Simcyp Simulator  Software: A temporary (4-day) license is provided to subscribers of this course along with x1 office hour with an expert tutor. When you are ready to start the practice exercises in this course, contact us to request your license and arrange your office hour.  Accessing the Course: After registering for this course, access your Dashboard.  You will have access to this course for a period of 1 month 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 7 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 14+ hours to complete, including time to perform the tasks in the Simcyp Simulator. Instructors: Detais in agenda Lectures and topics discussed: General introduction to the course Video 1. INTRODUCTION Dermal absorption – introduction and fundamentals of the skin and model structures, diseased populations Video 2.  SKIN STRUCTURE AND MPML MechDermA MODEL GENERAL STRUCTURE and ASSUMPTIONS, Part 1 Video 3.  SKIN STRUCTURE AND MPML MechDermA MODEL GENERAL STRUCTURE and ASSUMPTIONS, Part 2 Dermal absorption – mathematical principles of the MPML MechDermA model Video 4. MPML MechDermA MODEL (COMPOUND) PARAMETRIZATION Video 5. MPML MechDermA MODEL OUTPUTS Dermal absorption – how to account for variability in various populations Video 6. DERMAL TRIAL DESIGN – MULTIPLE APPLICATION SITES Video 7. SOURCES OF INTER-INDIVIDUAL VARIABILITY Video 8. PARAMETER INTER-APPLICATION SITE VARIABILITY– 1 video Dermal absorption – role of drug formulation and its metamorphosis on API absorption Video 9. IN VITRO TOPICAL FORMULATION CHARACTERIZATION Video 10. FORMULATION MODELS and TOOLBOX – SOLUBILITY PREDICTION Video 11. HOW TO MODEL DRUG METAMORPHOSIS  Video 12. DERMAL ABSORPTION - LUA SCRIPTING, PARAMETER ESTIMATION AND SENSITIVITY ANALYSIS Simcyp dermal module demo: IVPT module and dermal IVIVE examples Video 13. SKIN PERMEATION IN VITRO Video 14. IVPT MODULE AND ACCOUNT FOR LLOQ IN THE SIMULATIONS Video 15. IVPT MODULE CASE STUDY Virtual BE – concepts and application examples Video 16. VIRTUAL BE FOR DERMAL FORMULATIONS – CONCEPTS Video 17. TOPICAL PRODUCT VBE CASE STUDY Hands-on work-throughs: Hands-on workshop on the quantitative prediction of dermal absorption Hands-on workshop on population variability in dermal absorption Hands-on workshop on role of drug formulation and its metamorphosis on API absorption Hands-on workshop on IVPT module and dermal IVPT Hands-on workshop on virtual bioequivalence Read more

This on-demand workshop focusses on in silico-based mechanistic predictions of rectal and vaginal drug absorption. The workshop will include the details of the Simcyp models simulating rectal and vaginal absorption. Case studies, including in-depth understanding of the model parameterization and prediction of systemic plasma concentrations after rectal and vaginal administration, will be presented. Additionally, examples of virtual bioequivalence (VBE) concepts related to vaginal delivery will be discussed. Course Structure Duration: Accessible for one month post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by completing the course.  Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and tutors avaibale during office hours to suit you.  No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Prerequisites: Delegates should be familiar with the Simcyp Simulator  Software: A temporary (2-day) license is provided to subscribers of this course along with x1 office hour with an expert tutor. When you are ready to start the practice exercises in this course, contact us to request your license and arrange your offcie hour.  Accessing the Course: After registering for this course, access your Dashboard.  You will have access to this course for a period of 1 month 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 3 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 6+ hours to complete, including time to perform the tasks in the Simcyp Simulator. Instructors:  Kanika Thakur is working as a Research Scientist II at Certara Predictive Technologies, UK. Since joining Certara, her work has mainly focused on dermal simulator development and related consultancy projects, FDA-funded research projects and non-oral routes of delivery. She is leading the development of vaginal model and related consultancy projects. Kanika obtained her PhD from Panjab University, India and has extensive experience in developing topical formulations, conducting in vitro and in vivo dermal absorption assessment studies. She has authored more than 30 publications in the domain of topical drug delivery for dermal diseases including psoriasis, atopic dermatitis, osteoarthritis and burn wound infections.  Yuri Dancik is an Associate Principal Scientist at Certara Predictive Technologies. At Certara he leads or contributes to model development and consultancy projects, as well as FDA-funded research, focusing on dermal, rectal and oral drug absorption. Yuri’s professional background is in skin permeability and topical drug delivery. Prior to joining Certara in 2020, he held academic and industry positions at the University of Queensland, Procter and Gamble, the Agency for Science, Technology and Research (A*STAR) in Singapore and the University of Tours, France. To date, he has published over 30 peer-reviewed papers and book chapters and 2 patents. Yuri has a Ph.D. in Chemical and Biological Engineering from the State University of New York at Buffalo.  Lectures and topics discussed General introduction to the course INTRO 5-10 minutes – 1 video 2. Rectal absorption – Introduction and fundamentals RECTAL PHYSIOLOGY 15-20 minutes – 1 video RECTAL DRUGS AND FORMULATION TYPES 20-25 minutes- 1 video 3. Rectal absorption – Simcyp’s MechRAM model MechRAM MODEL GENERAL STRUCTURE AND ASSUMPTIONS 20 minutes – 1 video MechRAM MODEL PARAMETRIZATION 20 minutes – 1 video MechRAM MODEL OUTPUTS 15 minutes – 1 video OVERVIEW OF MechRAM HANDS-ON WORSHOPS  10-15 minutes – 1 video 4. Simcyp MechRAM demo MechRAM MODEL DEMO 20 minutes – 1 video 5. Vaginal absorption - Introduction and fundamentals VAGINAL PHYSIOLOGY 15-20 minutes – 1 video  VAGINAL DRUGS AND FORMULATION TYPES 20-25 minutes- 1 video Vaginal absorption –MechVAM model MechVAM MODEL GENERAL STRUCTURE AND ASSUMPTIONS 20 minutes – 1 video MechVAM MODEL PARAMETRIZATION 20 minutes – 1 video MechVAM MODEL OUTPUTS 15 minutes – 1 video Vaginal absorption –MechVAM model demo MechVAM MODEL DEMO 20 minutes – 1 video Vaginal absorption –MechVAM model Case study VAGINAL PBPK MODEL FOR DAPIVIRINE RING AND GEL FORMULATION 20 minutes- 1 video VAGINAL PBPK MODEL FOR ETONOGESTREL AND ETHINYLESTRADIOL RINGS USING IN VITRO DISSOLUTION DATA 20 minutes- 1 video   Hands-on workshop 1: Quantitative prediction of a drug’s rectal absorption using an empirical in vitro dissolution profile as formulation input Hands-on workshop 2: Quantitative prediction of a drug’s rectal absorption using the diffusion layer model as formulation input Read more

Long Acting Injectables Focussed Workshop   Learn how to develop in vitro release and in vivo pharmacokinetic models using long acting injectable module of Simcyp Simulator. The course will review the PBPK modelling and building of models to predict drug release. The users are not expected to have prior knowledge but are expected to learn quickly!  You will also learn model applications for evaluating the virtual bioequivalence by applying population variability to systemic parameters (volume of distribution, clearance, etc.)  Course Structure Duration: Accessible for one month post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by completing the course.  Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and tutors avaibale during office hours to suit you.  No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Prerequisites: Delegates should be familiar with the Simcyp Simulator  Software: A temporary (4-day) license is provided to subscribers of this course along with x1 office hour with an expert tutor. When you are ready to start the practice exercises in this course, contact us to request your license and arrange your office hour.  Accessing the Course: After registering for this course, access your Dashboard.  You will have access to this course for a period of 1 month 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 4 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 8+ hours to complete, including time to perform the tasks in the Simcyp Simulator. Instructors: Detais in agenda Time    Lectures and topics discussed  15 min  Introduction to long acting injectables and considerations to be given for modeling the polymer-based long acting injectables  25 min  A lecture on model theory for polymer based LAIs   15 min  In vitro release testing: Current gaps and experiments/formulation CQA, IVRT module         40 min  Parameterization of in vitro and in vivo models  40 min  Application of parameter estimation and sensitivity analysis in relation to long acting injectable implant models  30 min  Virtual bioequivalence testing of PLGA based long acting injectables    Hands-on workshop In vitro release testing of a solid implant (HOS1)    Hands-on workshop In vitro in vivo extrapolation to predict the clinical pharmacokinetics of Buserelin (HOS2)    Hands-on workshop Prediction of in vivo clinical pharmacokinetics using a case study for in situ gel-forming implant (HOS3)    Hands-on workshop Virtual Bioequivalence- Testing of VBE on a hypothetical case study on solid implants (HOS4)  Read more

December 9-13, 2024 | ONLINE This course broadens the range and utilization of in silico-based mechanistic prediction and analysis of drug absorption after oral delivery, including the development of mechanistic physiologically based in vitro-in vivo correlations (IVIVCs), virtual bioequivalence (VBE) concepts, and application of biopharmaceutic IVIVE using the SIVA Toolkit. We strongly recommend attending Oral Absorption I before taking this workshop. Read more

March 3-5, 2025 | IN PERSON (Bethesda, Washington DC) This workshop aims to enhance understanding and practical application of PBPK modelling in drug development and regulatory interactions. It covers both foundational concepts and real-world case studies, providing valuable insights for researchers in industry, academia, and regulators. The workshop will cover: 1. A quick introduction to PBPK modelling and exploration of extrinsic (e.g., concomitant medications) and intrinsic factors (e.g., age, organ dysfunction, genetics) on drug exposures. 2. Best Practices in PBPK model development covering integration of data from various sources, context of use and model assessment. When you can use PBPK models for extrapolation and regulatory applications. 3. Real-World case studies including drug-drug interactions, supporting dosing recommendations, application of PBPK in diverse patient groups (e.g., paediatrics, elderly, organ dysfunction) and Biopharmaceutical applications.   VENUE: Embassy Suites by Hilton Washington DC Chevy Chase Pavilion, 4300 Military Road NW, Washington, District of Columbia, 20015, USA TIME: 09:00 - 17:00 each day  CONSORTIUM MEMBER PONTS: 3 points per person LAPTOP: Delegates are required to bring a laptop computer, and will be provided with access to the Simcyp Simulator via Amazon Workspaces for the duration of the course.  COURSE MATERIAL: will be provided electronically via LearnUpon Read more