Pharmacokinetics (PK) is a crucial aspect of pharmacology that examines the dynamic changes of a drug in the body. It encompasses the process of drug absorption, distribution, metabolism, and excretion, particularly the variations in blood drug concentration over time. For macromolecular drugs, such as monoclonal antibodies, peptides, fusion proteins, and bispecific antibodies, LBA methods are usually used to quantitatively determine their PK and the concentration of drug-soluble targets.

For bioanalytical methods supporting preclinical and clinical research in PK, adherence to GLP regulations and guidelines is essential. The accuracy, precision, selectivity/matrix effect, dilution linearity and hook effect, parallelism, specificity, and stability are evaluated to verify the methods. As a professional macromolecular biological analysis laboratory complying with GLP quality management standards, Accurant has extensive experience in the biological analysis of PK samples for a wide range of macromolecular drugs for pre-clinical and clinical trials.