Course Description
Biologics continue to be a steadily growing component of the pharmaceutical industry. Large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This webinar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK and ADA assays for biologics. We will speak to changes in regulatory agency expectations with specific key analysis of assay variability, considerations for disease specific matrices, and using design of experiments in early development. Troubleshooting assays in production will also be discussed. The format of the webinar offers an examination of current best practices as well as time to dissect attendee-specific questions in an interactive manner.
PK and ADA Assays for Biologics (US)
Dr. Wise-Blackman is a consultant and project lead at BioData Solutions, with over 24 years of experience. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.
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Course Description
Biologics continue to be a steadily growing component of the pharmaceutical industry. Large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This webinar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK and ADA assays for biologics. We will speak to changes in regulatory agency expectations with specific key analysis of assay variability, considerations for disease specific matrices, and using design of experiments in early development. Troubleshooting assays in production will also be discussed. The format of the webinar offers an examination of current best practices as well as time to dissect attendee-specific questions in an interactive manner.
PK and ADA Assays for Biologics (US)
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