Development and Validation of Bioanalytical Assays for Biologics: Quantification (PK) and Immunogenicity Assays
April 12 - 13, 2012 - Berlin PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of bioanalytical assays in a GLP laboratory. Upon completion of this course, participants will have a detailed understanding of regulatory agency expectations for bioanalytical development, and will have gained the background knowledge necessary to effectively plan bioanalytical assay development and validation programs for both quantitation assays and PK studies. Additionally, attendees will learn to develop immunogenicity assays for detecting anti-drug antibodies for both marketed products and products in clinical development. Attendees will develop expertise in writing protocols, reports performing calculations, and acceptance limits for bioassay method validation.