Clinical Pharmacology and Pharmacometrics, Exploratory Clinical and Translational Research, Bristol-Myers Squibb , Princeton, NJ, USA.
Front Pharmacol. 2014 Nov 10;5:247. doi: 10.3389/fphar.2014.00247. eCollection 2014.
The empirical hypothesis generation and testing approach to pharmaceutical research and development (R&D), and biomedical research has proven very effective over the last half-century; resulting in tremendous increases productivity and the rates of approval for new drug applications at the Food and Drug Administration (FDA). However, as discovery of new therapeutic approaches for diseases with unmet medical need becomes more challenging, the productivity and efficiency of the traditional approach to drug discovery and development is diminishing. Innovative approaches are needed, such as those offered by Quantitative Systems Pharmacology (QSP) modeling and simulation. This "systems" approach to modeling and simulation can be used to guide the hypothesis generation and testing process in pharmaceutical R&D, in a manner similar to its adoption in other industries in the past. Embedding QSP into the existing processes within pharmaceutical discovery and development will be required in order to realize the full beneficial impact of this innovative approach.
在过去的半个世纪里,经验假设生成和测试方法在药物研发(R&D)和生物医学研究中已被证明非常有效;这导致了在食品和药物管理局(FDA)新药申请的批准率和生产率的大幅提高。然而,随着对未满足医疗需求的疾病的新治疗方法的发现变得更加具有挑战性,传统的药物发现和开发方法的生产力和效率正在下降。需要创新的方法,例如定量系统药理学(QSP)建模和模拟所提供的方法。这种“系统”建模和模拟方法可用于以类似于过去在其他行业中采用的方式来指导药物研发中的假设生成和测试过程。为了实现这种创新方法的全部有益影响,需要将 QSP 嵌入到药物发现和开发中的现有流程中。