Conclusions

Overall, there is a compelling need for in vitro toxicity biomarkers for clinical endpoints. Toxicity biomarkers in the in vitro context are defined as quantitative measurable characteristics that serve as indicators of a pathologic process or related biochemical or molecular events. Conceptually, bridging biomark-ers of toxicity should include not only the traditional parameters of biofluid and physiological measurements, but also measurable endpoints that could serve as indicators of potential adverse events preclinically and clinically even though they have been derived from in vitro, ex vivo, and in vivo studies. The use and application of this combination will undoubtedly improve the toxi-cologist's ability to identify human hazards so that the appropriate risk assessment and management strategy can be developed. In developing in vitro assays to identify biomarkers with potential clinical application and utility, a clear understanding and determination of what that biomarker will assess must be defined. For example, exaggerated pharmacologic action of a molecular target may be associated with an undesirable effect resulting in toxicity. In such cases, single/multiple markers and/or assays may be required for utilization in screens during the early drug discovery phase, with continued assessment in preclinical and clinical development. If successful, these data can be invaluable in deriving the therapeutic index of a drug. In the case of a specific target organ toxicity, the ultimate goal is to identify biomarkers of toxicity that can be used as a general screen that reflects cellular damage, regardless of mode of action in a high-throughput manner. Therefore, it is imperative that in vitro assays and the appropriate platforms be developed to identify relevant toxicity biomarkers that will be useful during preclinical and clinical development.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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