Pharmacokinetics and ADME properties of therapeutic biologics, including molecular weight, substitutions of charged amino acids, FcRn interaction, target-mediated drug disposition (TMDD) and chemical modifications, are important attributes for the safety and efficacy of these new drug modalities. The increasing complexity of therapeutic biologics demands more mechanistic ADME studies for many unsolved fundamental questions. The current DMD special section on “Pharmacokinetics and ADME of Biological Therapeutics” features eight review or research articles covering a wide range of topics, including industry perspectives, a white paper from the working group of The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), model-informed drug development of therapeutic biologics, the fate of the PEGylated copolymers, mechanistic investigation of renal elimination, and ADME characteristics and adverse drug reactions of antisense oligonucleotide (ASO) drugs. These articles fully acknowledged the current knowledge gaps and described various technologies and the best practices that may expedite the evaluation of new therapeutic biologics using more efficient ADME studies and mathematical and mechanistic PK models.
All content in the special section on Pharmacokinetics and ADME of Biological Therapeutics is freely accessible through January 2023.