TY - JOUR AU - Zhao Liang AU - Ren Tian-hua AU - Wang Diane D PY - 2016 TI - Clinical pharmacology considerations in biologics development JF - Acta Pharmacologica Sinica; Vol 33, No 11 (November 2012): Acta Pharmacologica Sinica (Special Feature: Pharmacometrics) Y2 - 2016 KW - N2 - Biologics, including monoclonal antibodies (mAbs) and other therapeutic proteins such as cytokines and growth hormones, have unique characteristics compared to small molecules. This paper starts from an overview of the pharmacokinetics (PK) of biologics from a mechanistic perspective, the determination of a starting dose for first-in-human (FIH) studies, and dosing regimen optimisation for phase II/III clinical trials. Subsequently, typical clinical pharmacology issues along the corresponding pathways for biologics development are summarised, including drug-drug interactions, QTc prolongation, immunogenicity, and studies in specific populations. The relationships between the molecular structure of biologics, their pharmacokinetic and pharmacodynamic characteristics, and the corresponding clinical pharmacology strategies are summarised and depicted in a schematic diagram. UR - http://www.chinaphar.com/article/view/4303