Basic concepts in development and validation of assays for pharmacokinetic analysis continue to be a constant presence in an evolving pharmaceutical industry. Even with the advent of new modalities, such as bi-specific antibody drugs and oligonucleotide drugs, the process to develop and validate PK assays is like that for large molecule simple antibody therapeutic agents. This online seminar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK assays for biologics. Specifically addressed are regulatory agency expectations with key analysis of assay variability, considerations for disease specific matrices, and using checkerboard approaches in early development. The format of the online seminar offers an examination of current best practices to guide attendees toward a better approach to achieving rugged validated assays.