Nonclinical and Clinical Bioanalytical Assay Requirements for Biosimilar Drug Development

An important aspect of planning any biosimilar drug development program is the development and validation of robust bioanalytical assays to accompany nonclinical and clinical studies. Although many of these assays are not unique to biosimilar programs and follow regulatory guidelines in their respective areas, there is a clear lack of detail in the description of how these assays should be developed, validated and implemented with respect to the intricacies of demonstrating biosimilarity.

This webinar highlights accepted strategies that can be used to develop and validate bioanalytical assays to support nonclinical and clinical studies.

Presenter

  • Kelly Colletti, PhD, MBA, Senior Research Scientist, Laboratory Sciences, Charles River


Please see the links below for the other webinars in the series:

Use of CROs to Speed the Development of Biosimilars

MoA Reflecting Bioassays to Confirm Biosimilarity

The Role of Mass Spectrometry in Demonstrating Biosimilarity