Description
This on-demand workshop focusses on silico-based mechanistic predictions of rectal and vaginal drug absorption. The workshop will include 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 30-days 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 (please allow up to 48hrs) 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 30-days 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.
Lucy Coleman is currently a Research Scientist in Certara UK. She received her PhD in Chemical Engineering from the University of Surrey in 2021. Her research focused on the computational modelling of topical actives absorption into the skin and subsequent metabolism. Prior to joining Simcyp, she was a postgraduate research associate in the Chemical and Process Engineering department in collaboration with the Comparative Biomedical Sciences department, both within the University of Surrey, with a research focus on antibacterial and antibiofilm activities of topical formulation components. Alongside this, she was Scientific Project Manager for CropLife Europe. Since joining Simcyp, her work has been on FDA-funded research, dermal simulator development and compound file development/update.
Krishna Chaitanya Telaprolu is a Senior Research Scientist in the Modelling and simulation group at Certara UK Ltd Simcyp Division. Currently, he leads or contributes to model development and consultancy projects, as well as FDA-funded research on VBE workflows grant, long-acting injectable projects, dermal related consultancy projects and non-oral routes of delivery projects. He worked previously in the dermal formulation grant and lead for last 10 months of grant period, worked for PBPK modelling of dermal absorption through diseased skin grants and involved in IVPT module development. Krishna obtained his PhD from The University of Queensland, Australia and has experience in designing topical formulations, performing practical in vitro and in vivo dermal absorption studies. To date, he has published over 16 peer-reviewed papers and 1 chapter of a book. Prior to his PhD and joining Simcyp in July 2019, he worked for about 2 years as a Formulation Research fellow, responsible for developing Parenteral drug products for both ANDA and 505b2 applications in Emcure Pharmaceuticals, India.
Alexandre Djehizian is a Research Scientist II in the modeling and simulation group at Certara UK Ltd Simcyp Division. He has a background in applied mathematics and mathematical modeling, translating complex real-world problems into analytical and numerical solutions. He obtained a PhD in mathematics from Imperial College London in 2021. At Certara, he is part of the long-acting injectable team where he worked on mechanistic modeling of PLGA implants, PLGA microspheres and intra-muscular formulation suspensions. He worked on other projects that required mechanistic modeling, such as drug delivery from polymeric tablets for oral absorption. He also is interested in the application of machine learning and deep learning techniques in predicting key physico-chemical parameters, and has worked on several projects in that regard.
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Lectures and topics discussed |
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RECTAL MODEL PRE-RECORDED WORKSHOP |
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LECTURE 1. INTRODUCTION LECTURE 2. BASICS OF RECTAL PHYSIOLOGY LECTURE 3. RECTAL DRUGS AND FORMULATION LECTURE 4. RECTAL ABSORPTION MODEL AND STRUCTURE LECTURE 5. RECTAL ABSORPTION MODEL PARAMETRIZATION LECTURE 6. RECTAL ABSORPTION MODEL OUTPUTS |
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Hands-on workshop 1: Sodium Naproxen suppositories – Familiarization with Model |
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Hands-on workshop 2: Sodium Naproxen suppositories – Initial Simulation |
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Hands-on workshop 3: Sodium Naproxen suppositories – Optimizing the Simulation |
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Hands-on workshop 4: Sodium Naproxen suppositories – Evaluating the Impact of In Vitro Drug Release Data |
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VAGINAL MODEL PRE-RECORDED WORKSHOP |
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LECTURE 1. INTRODUCTION TO MechVAM MODEL LECTURE 2. FUNDAMENTALS OF VAGINAL PHYSIOLOGY LECTURE 3. VAGINAL DRUGS AND FORMULATION TYPES LECTURE 4. MECHVAM MODEL STRUCTURE AND GENERAL ASSUMPTIONS LECTURE 5. MECHVAM MODEL PARAMETRIZATION LECTURE 6. MECHVAM VAGINAL ABSORPTION MODEL OUTPUTS |
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Hands-on workshop 1: Dapvirine Gel and Ring formulation |
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Hands-on workshop 2: Etonogestrel and Ethinyl Estradiol Ring formulation |
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Hands-on workshop 3: Clindamycin Phosphate Cream |
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Hands-on workshop 4: Virtual Bioequivalence for Vaginal formulations |
Objectives
Key aspects covered in this course:
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Brief description of rectal and vaginal physiology.
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In-depth description of drugs administered through rectal and vaginal routes, including formulation types.
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Detailed summary of the Mechanistic Rectal Absorption Model (MechRAM) and the Mechanistic Vaginal Absorption Model (MechVAM) structure and underlying assumptions.
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Overview of MechRAM and MechVAM model parametrization for simulating the absorption of drug from the rectal and vaginal routes.
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Summary of rectal and vaginal absorption model outputs.
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Case studies with different types of rectal and vaginal formulations including rectal suppositories, vaginal cream, gel, and vaginal ring formulations.
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Example of virtual bioequivalence analysis for vaginally applied formulations with discussion around case study.
User Accounts and Registrations
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Course Materials
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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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