Description
(005-OD) Dermal | On-Demand Workshop (V25)
Description
This workshop focuses on the mechanistic, in silico prediction of dermal drug absorption. It covers the models used to predict skin absorption following topical application, with practical examples of mechanistic physiologically-based in vitro–in vivo correlations (IVIVCs) and virtual bioequivalence (VBE).
Course Structure
The course is accessible for 30 days from the date of registration. It provides approximately 7 hours of video instruction, including a practical component you can work through at your own pace. Total completion time — including hands-on exercises in the Simcyp Simulator — is estimated at 14+ hours. On successful completion, you will receive a certificate of achievement.
To support active engagement, recordings and lecture slides are not available for download.
Prerequisites: Delegates should be familiar with the Simcyp Simulator.
Software: A temporary 4-day Simcyp Simulator licence is provided with this course, along with one office hour with an expert tutor. When you are ready to begin the practical exercises, please contact us to request your licence (allow up to 48 hours) and to arrange your office hour session.
Once registered, access the course via your Dashboard. Each purchase covers a single seat — login credentials must not be shared. Additional seats must be purchased separately for each individual.
Instructors: Details in the agenda.
Lectures and Topics
General Introduction
Video 1: Introduction
Dermal Absorption – Fundamentals, Skin Structure, and Model Architecture
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
Mathematical Principles of the MPML MechDermA Model
Video 4: MPML MechDermA Model – Compound Parameterisation
Video 5: MPML MechDermA Model Outputs
Accounting for Variability Across Populations
Video 6: Dermal Trial Design – Multiple Application Sites
Video 7: Parameterisation of Inter-Individual Variability
Drug Formulation and API Absorption
Video 8: In Vitro Topical Formulation Characterisation
Video 9: Formulation Models and Toolbox – Solution
Video 10: Formulation Models and Toolbox – Patches
Video 11: How to Model Drug Metamorphosis
Video 12: Dermal Absorption – Lua Scripting, Parameter Estimation and Sensitivity Analysis
IVPT Module and Dermal IVIVE
Video 13: Skin Permeation In Vitro
Video 14: IVPT Module and Accounting for LLOQ in Simulations
Video 15: IVPT Module Case Study
Virtual Bioequivalence – Concepts and Applications
Video 16: Virtual BE for Dermal Formulations – Concepts
Video 17: Topical Product VBE Case Study
Hands-On Work-Throughs
- MPML GUI and functionality
- Trial design and inter-application site correlation
- Role of drug formulation and API absorption
- IVPT module and generic membrane model
- IVPT and IVIVE
- Dermal virtual bioequivalence
Objectives
Key Aspects Covered in This Course
- Recognise the opportunities and challenges of applying quantitative modelling and simulation tools in dermal drug formulation development.
- Apply the Multi-Phase Multi-Layer (MPML) MechDermA model to simulate drug absorption through the skin.
- Build a physiologically based pharmacokinetic (PBPK) framework for modelling in vitro and in vivo skin permeation of topical and transdermal products, including dermal in vitro–in vivo extrapolation (IVIVE).
- Use the IVPT module for in vitro release and skin permeation simulations and extrapolation to the in vivo situation (IVIVE).
- Work with a range of topical formulation types, including solutions, emulsions (O/W, W/O), emulsions with solid particles, suspensions, and patches.
- Understand and model the metamorphosis of topical formulations upon application to the skin surface.
- Develop mechanistic physiologically-based in vitro–in vivo correlations (IVIVCs) for dermally applied products, with reference to relevant case studies.
- Evaluate virtual bioequivalence for dermally applied products through case study discussion.
Certificate
By completing/passing this course, you will attain the certificate New Cert Blank Juul26
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
There are no refunds for e-Learning courses or certifications. Course expiration dates can be found on your Dashboard.
Electronic Communication
We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions. We will also send email for general announcements about the site. You can opt out of these emails if you wish (located in your profile).
Details
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