The Use of Solubilizing Excipients and Approaches to Generate Toxicology Vehicles for Contemporary Drug Pipelines

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The purpose of this chapter is two-fold and includes approaches for identifying potentially problematic drug candidates with regard to formulation, in general, and for the preparation of toxicology vehicles, in particular. In addition, an attempt is made to provide insight as to what oral and parenteral excipients are appropriate for early human testing and, by extension, which of these materials can reasonably be used in GLP toxicology evaluation intended to support these Phase I human assessments. These considerations are becoming more visible in the drug development arena as evidenced by a number of recent symposia and congresses (Liu 2005; Van Gelder, 2006).