With increasing expectations to provide evidence of drug efficacy, safety, and cost-effectiveness, best-in-class drugs are a major value driver for the pharmaceutical industry. Superior safety is a key differentiation criterion that could be achieved through better risk:benefit profiles, safety margins, fewer contraindications, and improved patient compliance. To accomplish this, comparative safety assessments using innovative and adaptive nonclinical and clinical outcome-based approaches should be undertaken, and continuous strategic adjustments must be made as the risk:benefit profiles evolve. Key success criteria include scientific expertise and integration between all disciplines during the full extent of the drug development process.

随着人们越来越期望提供药物功效，安全性和成本效益的证据，一流的药物是制药行业的主要价值驱动力。更高的安全性是一项关键的区分标准，可以通过以下更高的风险来实现：收益概况，安全系数，禁忌症减少和患者依从性提高。为了实现这一目标，应该使用创新的，适应性的非临床和基于临床结果的方法进行比较安全性评估，并且必须随着风险：收益概况的发展而进行持续的战略调整。成功的关键标准包括在药物开发过程的整个过程中科学专业知识以及所有学科之间的整合。