Description
This workshop will explain the principle of therapeutic protein pharmacokinetic and pharmacodynamic modelling. Distribution, clearance, FcRn recycling, target-mediated drug disposition (TMDD), and subcutaneous absorption will be covered for monoclonal antibodies and other therapeutic proteins. Additionally, the suppression of CYP enzymes by cytokines and thus interactions between biologics and small molecule drugs will be simulated. Participants will learn how to apply these models using case studies.
Live Online Courses
There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
Objectives
Key aspects covered in this course:
• The use of minimal physiologically-based pharmacokinetic models for both mAbs and other therapeutic proteins
• The use of the full PBPK models for therapeutic proteins available within the Simulator
• Prediction of pharmacokinetics of therapeutic proteins in populations as well as in an average individual
• Utilisation of the 2-pore calculation to predict the distribution of therapeutic proteins
• Use of the allometric calculator tool
• The effect of FcRn affinity and charge state on the pharmacokinetics of monoclonal antibodies
• Demonstrating the utility of the target mediated drug disposition models (TMDD) within the Simulator
• The use of TMDD models that can account for the shedding of target from the cell surface into the interstitial space and plasma
• Linking the biologics/TMDD models to simulate pharmacodynamic effects
• Modelling the interaction between biologics and small molecule drugs
• Modelling subcutaneous / intramuscular absorption of therapeutic proteins
Certificate
By completing/passing this course, you will attain the certificate Certificate of Completion - Biologics
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
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Details
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