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Overcoming Bioanalytical Challenges for PK/PD Assessment in Phase I Biologics Studies – Upcoming Webinar Hosted by Xtalks

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Because of the diverse nature of biologics, no single bioanalytical approach can fulfill all the requirements. Analytical techniques are often used in conjunction, including immunoassays; and LCMS-based methods, which have exquisite specificity.


TORONTO (PRWEB)

This webinar will outline key clinical and bioanalytical considerations to enable appropriate pharmacokinetics/pharmacodynamics (PK/PD) data for biologics. It will also highlight practical considerations for the successful conduct of first-in-human Phase I studies for biologics where substantial and challenging bioanalysis is required.

The clinical site relies on the bioanalytical experts to generate critical data needed for the understanding of PK/PD parameters. Because of the diverse nature of biologics, no single bioanalytical approach can fulfill all the requirements. Analytical techniques are often used in conjunction, including immunoassays; and LCMS-based methods, which have exquisite specificity.

In this webinar, the following three areas will be discussed to optimize the clinical site and bioanalytical teams’ partnerships:


  •     Planning for bioanalytical endpoints in Phase I biologics studies, with special emphasis on design and sample preparation

  •     Assay selection, requirements, and regulatory expectations

  •     Novel workflows focused on minimizing cost and timelines

Register for this webinar to learn how challenges can be overcome by partnering with fully integrated bioanalytical laboratories that support clinical sites as well as preclinical toxicology. This ensures expertise and familiarity of the principal investigators and bioanalytical scientists throughout all phases of drug development.

Join expert speakers from Altasciences: Dr. Lynne Le Sauteur, PhD, Vice President, Laboratory Sciences, and Dr. David Nguyen, MD, MBA, General Manager and Medical Director, for a live webinar on Thursday, November 4, 2021 at 1pm EDT (10am PDT).

For more information, or to register for this event, visit Overcoming Bioanalytical Challenges for PK/PD Assessment in Phase I Biologics Studies.

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/

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