The process of searching for new canter drugs has evolved from rationa
l empiricism using high volume murine screens towards more targeted sy
stems designed to discover agents which are specifically active agains
t the common solid tumors of adulthood. Irrespective of the method of
discovery, animal models are necessary in cancer drug development to a
nswer fundamental questions of drug pharmacology and end organ toxicit
y. This knowledge is fundamental to the design of Phase I clinical tri
als. Increasingly, ani mal models are being utilized in the earliest s
tages of cancer drug discovery, as well as finding new uses guiding do
se escalation in man. In addition, transgenic and SCID model systems h
ave special applicability to the preclinical and clinical development
of biological agents. This article reviews the emerging roles of anima
l models in cancer drug discovery and development.