The proposed Drug Development Shared Resource is designed to facilitated preclinical drug development leading to selection of new agents for clinical trial. It is composed of two sections, one devoted to preclinical Toxicology. The Preclinical Pharmacology Section, headed by Dr. Bernacki, will evaluate, using human in vitro and in vivo tumor model systems, the biological and therapeutic activity of potential anti- tumor agents and treatments, derived as a result of research being carried out by investigators in the CCSG Programs, or if relevant to the Institute's goals, from outside sources. Based on information regarding the activity and mechanism of action of thee new compounds, combinations of agents (e.g., polyamine analogs and inhibitors) or treatments (e.g., anti-angiogenic chemotherapy and photodynamic therapy) will also be evaluated. Preclinical pharmacological studies will be performed to assess both pharmacokinetic parameters and drug metabolism. The Preclinical Toxicology Section of this Resource, headed drugs and treatments. The primary service provided will be the preclinical toxicologic evaluation of new agents or treatments in rats and dogs. All studies will be conducted under strict adherence to the Good Laboratory Practices (GLP) of the U.S. Food and Drug Administration (FDA). This Resource is capable of conducting all of the experimental and regulatory work necessary and sufficient for IND applications to the FDA prior to initial (Phase I and Phase I/II) clinical trials of new anti-cancer drugs in humans. The scope of these preclinical therapeutic and preclinical toxicology core resource activities forms an integral part of Roswell Park Cancer Institute Corporation's (RPCI) strategy for anti-cancer drug development, aiding in the design of new protocols for clinical trial. Both sections of the Drug Development Resource are available to all RPCI researchers with a need for services, and priority access is given to investigators with peer-reviewed funding. Final decisions regarding prioritization of projects is made my the Chemotherapy Strategy Committee.
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