Description
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
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Time |
Lectures and topics discussed |
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15 min |
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25 min |
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15 min |
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40 min |
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40 min |
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30 min |
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Hands-on workshop In vitro release testing of a solid implant (HOS1) |
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Hands-on workshop In vitro in vivo extrapolation to predict the clinical pharmacokinetics of Buserelin (HOS2) |
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Hands-on workshop Prediction of in vivo clinical pharmacokinetics using a case study for in situ gel-forming implant (HOS3) |
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Hands-on workshop Virtual Bioequivalence- Testing of VBE on a hypothetical case study on solid implants (HOS4) |
Objectives
Key aspects of the course:
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A brief overview of PBPK modeling using the Simcyp Simulator
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An introduction to long acting injectables and considerations to be given for modelling the polymer-based long acting injectables
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Modeling different processes in the case of solid/in situ implants during drug release for example wetting, polymer degradation, etc.
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In vitro release testing of solid implants
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Modeling the in vivo pharmacokinetics after administration of implants
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Optimization of PBPK model parameters with the help of sensitivity analysis and parameter estimation tool
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Virtual bioequivalence testing of drug products
Certificate
By completing/passing this course, you will attain the certificate LAI Cert 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
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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