) The objective of the Pre-Clinical Development Core Service F is to provide each project area with pre-clinical development services. These services will include evaluation of preliminary toxicology , formulation and Pharmacokinetic profiles of agents selected through the decision process. The hypothesis upon which work by the core service is based is that data obtained by in vitra screening with human tumor cell lines, with other in vitra cores and animal tumor models have predictive value for identifying agents which should undergo pre-clinical development. Additionally, Core F will provide further physicochemical data which will aid in the selection process of identifying promising drug candidates.
The aims of the core service are: 1) to evaluate the physicolchemical properties of agents selected from the in vitra analyses, and high-throughput screening; 2) to provide preliminary formulation of 8 agents per year that advance into early xenograft in viva testing; 3) to carry out preliminary toxicity and pharmacokinetic studies on 1 to 2 agents per year to further aid in the selection process for final drug selection; 4) to conduct a full pharmacokinetic evaluation in mice on potential clinical candidate. The ultimate goal of the core service is to prepare a drug candidate to move into the final re-clinical developments stages of GLP Toxicology and GMP syntheses.
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