What is a generic PK assay? A generic pharmacokinetic (PK) assay, also referred to as a universal PK assay for New Biologic Entities (NBE), is used to measure circulating human biotherapeutics—primarily antibody-based—post-administration across various non-human matrices. These assays are particularly beneficial when drug-specific reagents, such as anti-idiotype antibodies, are…

A pharmacokinetic (PK) assays evaluate how the body affects a specific substance after administration which includes: absorption, biodistribution, metabolism, and excretion. Preclinical (or non-clinical) PK assays play a crucial role in drug development and typically focus on assessing drug safety and maximum tolerable dose. For the development of pre-clinical PK…