Chapter-04 Phase 0 Trials in Cancer Drug Development
BOOK TITLE: Drug Discovery and Clinical Research
Author
1. Kummar Shivaani
2. Doroshow James H
ISBN
9789350252727
DOI
10.5005/jp/books/11216_4
Edition
1/e
Publishing Year
2011
Pages
12
Author Affiliations
1.
Medical Oncology Branch, National Cancer Institute, 9000 Rockville Pike Building 10, Room 13N240G, Bethesda, MD 20892
2.
Medical Oncology Branch, National Cancer Institute, 9000 Rockville Pike, Building 10, Room 13N240G, Bethesda, MD 20892
Chapter keywords
Phase I clinical trials,
Phase 0 Trials,
investigational New drug,
pharmacodynamic (PD) endpoints,
Primary endpoint,
PK/ PD analysis,
PD assay,
standard operating procedures,
PD assay validation,
IND-enabling studies,
new drug evaluations,
PARP activity,
ABT-888,
FDA approval rates,
oncology,
microdosing,
pharmacokinetics,
pharmacodynamics,
toxicology studies,
ADP-ribose,
DNA repair enzyme,
xenograft models,
PARP inhibition,
matrix metalloproteinase inhibitors