Bioanalytical Support of Biosimilars: Expect the Unexpected, Upcoming Webinar Hosted by Xtalks
In this complimentary webinar, Dr. Petra Struwe will discuss the direct impact of the biosimilar bioanalytical assay set-up and its impact on the statistical endpoint of the clinical trials comparing pharmacokinetic and/or pharmacodynamic (PK/PD) properties of a biosimilar drug candidate and its innovator compound.
TORONTO, Nov. 19, 2020 /PRNewswire-PRWeb/ -- The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is highly dependant upon the quality of the bioanalytical methods and design of early PK/PD drugs as well as the product similarity. Based on experiences gained from support of the first wave of biosimilar products to gain approval in the US and EU, Celerion will share key learnings from engagement with several biosimilar programs. This includes the rationale for the one assay approach and how the two-step approach can help set up such an assay.
A two-step approach refers to a robust validation of a single assay which includes both the innovator and biosimilar demonstrating analytical similarity and comparable reactivity. Challenges include extention of the limit of precision for ligand binding assays and how adapted routine analysis best practices can be applied to overcome these issues.
Join Dr. Petra Struwe, Executive Director of Bioanalytical Services, Celerion, for the live webinar on Wednesday, December 9, 2020 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Bioanalytical Support of Biosimilars: Expect the Unexpected.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Media Contact
Ayesha Rashid, Xtalks, +1 (416) 977-6555 x 272, [email protected]
SOURCE Xtalks

Share this article