Capítulo de livro

Working with the National Cancer Institute

1997; Humana Press; Linguagem: Inglês

10.1007/978-1-4615-8152-9_11

Autores

Edward A. Sausville,

Tópico(s)

Synthesis and biological activity

Resumo

The National Cancer Institute (NCI) has recently been reorganized, with drug development focused in the Division of Cancer Treatment, Diagnosis and Centers (DCTDC). The Developmental Therapeutics Program (DTP) of DCTDC promotes all aspects of the discovery and preclinical development of new compounds as drugs. Its activities include demonstration of antiproliferative activity in vitro through its 60 human tumor cell line screen and in vivo using tumor cell xenografts in athymic mice. Compounds of interest for further development are studied to develop a suitable formulation, optimal route and schedule, pharmacology, and toxicology. The Cancer Therapy Evaluation Program (CTEP) of DCTDC is responsible for submitting to the Food and Drug Administration Investigational New Drug Applications (INDAs) for those drugs in which the NCI will hold the IND and study in its peer-reviewed funded clinical trial groups, or as part of the activities of Phase I and II cooperative agreement organizations. CTEP also monitors the conduct of these studies as well as Phase III studies focusing on the optimal use of currently available FDA-approved agents.

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