caa a22 4500 605534055 CHVBK 20210128100841.0 cr unu---uuuuu 210128e20151001xx s 000 0 eng 10.1007/s10928-015-9447-8 doi (NATIONALLICENCE)springer-10.1007/s10928-015-9447-8 Shah Dhaval Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York at Buffalo, 455 Kapoor Hall, 14214-8033, Buffalo, NY, USA aut Pharmacokinetic and pharmacodynamic considerations for the next generation protein therapeutics [Elektronische Daten] [Dhaval Shah] Increasingly sophisticated protein engineering efforts have been undertaken lately to generate protein therapeutics with desired properties. This has resulted in the discovery of the next generation of protein therapeutics, which include: engineered antibodies, immunoconjugates, bi/multi-specific proteins, antibody mimetic novel scaffolds, and engineered ligands/receptors. These novel protein therapeutics possess unique physicochemical properties and act via a unique mechanism-of-action, which collectively makes their pharmacokinetics (PK) and pharmacodynamics (PD) different than other established biological molecules. Consequently, in order to support the discovery and development of these next generation molecules, it becomes important to understand the determinants controlling their PK/PD. This review discusses the determinants that a PK/PD scientist should consider during the design and development of next generation protein therapeutics. In addition, the role of systems PK/PD models in enabling rational development of the next generation protein therapeutics is emphasized. Springer Science+Business Media New York, 2015 Pharmacokinetic nationallicence Pharmacodynamic nationallicence Protein therapeutics nationallicence Biologics nationallicence Novel scaffold nationallicence ADME nationallicence Toxicity nationallicence Immunogenicity nationallicence Journal of Pharmacokinetics and Pharmacodynamics Springer US; http://www.springer-ny.com 42/5(2015-10-01), 553-571 1567-567X 42:5<553 2015 42 10928 https://doi.org/10.1007/s10928-015-9447-8 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10928-015-9447-8 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Shah Dhaval Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York at Buffalo, 455 Kapoor Hall, 14214-8033, Buffalo, NY, USA aut NATIONALLICENCE 773 0- Journal of Pharmacokinetics and Pharmacodynamics Springer US; http://www.springer-ny.com 42/5(2015-10-01), 553-571 1567-567X 42:5<553 2015 42 10928