Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: a case study of anticancer drug, crizotinib.

ABSTRACT: Attrition risk related to efficacy is still a major reason why new chemical entities fail in clinical trials despite recently increased understanding of translational pharmacology. Pharmacokinetic-pharmacodynamic (PKPD) analysis is key to translating in vivo drug potency from nonclinical models to patients by providing a quantitative assessment of in vivo drug potency with mechanistic insight of drug action. The pharmaceutical industry is clearly moving toward more mechanistic and quantitative PKPD modeling to have a deeper understanding of translational pharmacology. This paper summarizes an anticancer drug case study describing the translational PKPD modeling of crizotinib, an orally available, potent small molecule inhibitor of multiple tyrosine kinases including anaplastic lymphoma kin

SUBMITTER: Yamazaki S 

PROVIDER: S-EPMC3675733 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature