在早期临床开发阶段，选择合适的起始剂量和合适的方法来预测新型肿瘤药物的有效剂量提出了重大挑战。传统方法是利用毒理学研究的体表面积变换来预测首次人体（FIH）起始剂量，或简单选择最大耐受剂量（MTD）或最大给药剂量（MAD）作为有效剂量或推荐2期剂量（RP2D），对于新型肿瘤药物来说通常是不充分且有风险的。由于旨在改善肿瘤药物开发中剂量优化的监管努力，临床剂量选择现在正在从这些传统方法转向基于综合效益/风险评估的方法。定量药理学分析（QPA）在这一新范式中发挥着至关重要的作用。这篇小型综述总结了 QPA 在选择肿瘤 FIH 研究的起始剂量以及扩展或 2 期试验的潜在有效剂量方面的用途。 QPA 通过整合研究和开发阶段的信息，可以采取更合理、更科学的剂量选择方法。总之，QPA 在肿瘤药物开发中的应用有可能显着提高临床试验的成功率，并最终支持临床决策- 制作，特别是剂量选择。

The selection of appropriate starting dose and suitable method to predict an efficacious dose for novel oncology drug in the early clinical development stage poses significant challenges. The traditional methods of using body surface area transformation from toxicology studies to predict the first-in human (FIH) starting dose, or simply selecting the maximum tolerated dose (MTD) or maximum administered dose (MAD) as efficacious dose or recommended phase 2 dose (RP2D), are usually inadequate and risky for novel oncology drugs.Due to the regulatory efforts aimed at improving dose optimization in oncology drug development, clinical dose selection is now shifting away from these traditional methods towards a comprehensive benefit/risk assessment-based approach. Quantitative pharmacology analysis (QPA) plays a crucial role in this new paradigm. This mini-review summarizes the use of QPA in selecting the starting dose for oncology FIH studies and potential efficacious doses for expansion or phase 2 trials. QPA allows for a more rational and scientifically based approach to dose selection by integrating information across studies and development phases.In conclusion, the application of QPA in oncology drug development has the potential to significantly enhance the success rates of clinical trials and ultimately support clinical decision-making, particularly in dose selection.