Specificity of bioanalytical methods for pharmacokinetic support of biological macromolecular therapeutics is important

“...it is time for the bioanalytical community to pay greater attention to the specificity of methods for the quantitation of biologics in biological media, so that the most reliable estimates of pharmacokinetics, toxicokinetics and pharmacokinetics–pharmacodynamics are available to enhance success in the development of these agents.” Macromolecular compounds, including endogenous proteins, monoclonal antibodies and antibody–drug conjugates, and oligonucleotides such as Toll-like receptor agonists, aptamers, antisense agents and molecules designed to block RNA transmission of the protein-building message (siRNA), constitute an increasing number of agents in development as potential therapeutics for humans. Pharmaceutical Research and Manufacturers (PhRMA), the US industry association,...