Description
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
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Lectures and topics discussed: |
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General introduction to the course Video 1. INTRODUCTION |
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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 |
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Dermal absorption – mathematical principles of the MPML MechDermA model Video 4. MPML MechDermA MODEL (COMPOUND) PARAMETRIZATION Video 5. MPML MechDermA MODEL OUTPUTS |
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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 |
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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 |
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Simcyp dermal module demo: |
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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 |
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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:
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Hands-on workshop on the quantitative prediction of dermal absorption |
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Hands-on workshop on population variability in dermal absorption |
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Hands-on workshop on role of drug formulation and its metamorphosis on API absorption |
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Hands-on workshop on IVPT module and dermal IVPT |
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Hands-on workshop on virtual bioequivalence |
Objectives
Key aspects covered in this course:
- Recognize the opportunities and challenges in applying quantitative modelling and simulation tools in the field of dermal drug formulation development.
- The use of Multi-Phase Multi-Layer (MPML) MechDermA model for simulating the absorption of drug from the skin
- Development a physiologically based pharmacokinetic framework for modelling in vitro and in vivo skin permeation of topical/transdermal products – establishing dermal in vitro in vivo extrapolation
- Utilization of IVPT module for the in vitro skin permeation simulation and further extrapolation to in vivo situation (IVIVE)
- Dealing with different types of topically formulations – solutions, emulsions (O/W, W/O), emulsions with solid particles, suspensions, patches
- Understanding and modeling the metamorphosis of the topical formulations when applied on the skin surface
- Development of mechanistic physiologically-based in vitro-in vivo correlations (IVIVCs) for dermally applied with discussion around case studies
- Virtual bioequivalence for dermally applied with discussion around case studies
Certificate
By completing/passing this course, you will attain the certificate Dermal OD
User Accounts and Registrations
The email address used for your user login must be an individual account. No sharing of user accounts between multiple individuals is allowed. Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.
Course Materials
As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials.
Cancellation Policy
Live Online Courses
There are no refunds for Live Online courses for cancellation or non-attendance by the participant. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
e-Learning and Certifications
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