Description
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.
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Lectures and topics discussed |
INTRO 5-10 minutes – 1 video |
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2. Rectal absorption – Introduction and fundamentals RECTAL PHYSIOLOGY 15-20 minutes – 1 video RECTAL DRUGS AND FORMULATION TYPES 20-25 minutes- 1 video |
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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 |
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4. Simcyp MechRAM demo MechRAM MODEL DEMO 20 minutes – 1 video |
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5. Vaginal absorption - Introduction and fundamentals VAGINAL PHYSIOLOGY 15-20 minutes – 1 video VAGINAL DRUGS AND FORMULATION TYPES 20-25 minutes- 1 video |
MechVAM MODEL GENERAL STRUCTURE AND ASSUMPTIONS 20 minutes – 1 video MechVAM MODEL PARAMETRIZATION 20 minutes – 1 video MechVAM MODEL OUTPUTS 15 minutes – 1 video |
MechVAM MODEL DEMO 20 minutes – 1 video |
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 |
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Hands-on workshop 1: Quantitative prediction of a drug’s rectal absorption using an empirical in vitro dissolution profile as formulation input |
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Hands-on workshop 2: Quantitative prediction of a drug’s rectal absorption using the diffusion layer model as formulation input |
Objectives
Key aspects covered in this course:
- Brief description of rectal and vaginal physiology.
- In-depth description of drugs administered through rectal and vaginal routes, including formulation types.
- Detailed summary of the Mechanistic Rectal Absorption Model (MechRAM) and the Mechanistic Vaginal Absorption Model (MechVAM) structure and underlying assumptions.
- Overview of MechRAM and MechVAM model parametrization for simulating the absorption of drug from the rectal and vaginal routes.
- Summary of rectal and vaginal absorption model outputs.
- Case studies with different types of rectal and vaginal formulations including rectal suppositories, vaginal gel and vaginal ring.
- Example of virtual bioequivalence analysis for vaginally applied formulations with discussion around case study.
Certificate
By completing/passing this course, you will attain the certificate Rectal and Vaginal Abs Certificate
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.
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