Intrinsic and Extrinsic Pharmacokinetic Variability of Small Molecule Targeted Cancer Therapy.

ABSTRACT: Pharmacokinetic (PK) variability in cancer clinical trials may be due to heterogeneous populations and identifying sources of variability is important. Use of healthy subjects in clinical pharmacology studies together with detailed knowledge of the characteristics of patients with cancer can allow for quick identification and quantification of factors affecting PK variability. PK data and sources of variability of 40 marketed molecularly targeted oncology therapeutics were compiled from regulatory approval documents covering an 18-year period (1999-2017). Variability in PK parameters was compared and contributors to variability were identified. The results show that PK variability was ~ 16% higher for peak plasma concentration (C_max ) and area under the concentration time curve

SUBMITTER: Reyner E 

PROVIDER: S-EPMC7070882 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature