Open AccessTutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development
Author(s) -
Ovacik Meric,
Lin Kedan
Publication year - 2018
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.12567
Subject(s) - pharmacokinetics , monoclonal antibody , drug development , context (archaeology) , antibody , pharmacodynamics , medicine , drug , pharmacology , immunology , biology , paleontology
Abstract The tutorial introduces the readers to the fundamentals of antibody pharmacokinetics (PK) in the context of drug development. Topics covered include an overview of antibody development, PK characteristics, and the application of antibody PK/pharmacodynamics (PD) in research and development decision‐making. We also discuss the general considerations for planning a nonclinical PK program and describe the types of PK studies that should be performed during early development of monoclonal antibodies.