【摘 要】
：
Millions of dollars are spent yearly in experiments aimed at reducing the risks inherent in the prediction of toxicity and efficacy of compounds for human medical use.Nonetheless,the predictability of
【机 构】
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Pre-Clinical Safety Inc.USA
【出 处】
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中国上海第七届国际新药发明科技年会
论文部分内容阅读
Millions of dollars are spent yearly in experiments aimed at reducing the risks inherent in the prediction of toxicity and efficacy of compounds for human medical use.Nonetheless,the predictability of the animal models remains unacceptably low and the predictive failures are very common.Most of the compounds that enter the experimental funnel do not finalize the process to become drags,and the cost increases as leads are followed through the process through increasingly expensive and difficult decision points.Errors of commission (error # 1) and of omission (error #2) are common.Data from genomic models are used early in the process as a way to glean the probability of efficacy and/or safety risks.However the use of genomics data without a comprehensive approach to the whole animal is fraught with problems,as reviews of some publications indicate that assumptions are made regarding the nature of events that occur.Examples will be given of such issues.Also,during efficacy and safety studies,often conclusions are reached that are inaccurate due to the lack of accurate interpretation of the data coming from animal studies.
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