PDF(Pubmed)
Abstract：
Exposure-response (E-R) analyses are an integral component in the development of oncology products. Characterizing the relationship between drug exposure metrics and response allows the sponsor to use modeling and simulation to address both internal and external drug development questions (e.g., optimal dose, frequency of administration, dose adjustments for special populations). This white paper is the output of an industry-government collaboration among scientists with broad experience in E-R modeling as part of regulatory submissions. The goal of this white paper is to provide guidance on what the preferred methods for E-R analysis in oncology clinical drug development are and what metrics of exposure should be considered.
摘要：
暴露反应（E-R）分析是肿瘤学产品开发中不可或缺的组成部分。表征药物暴露指标和反应之间的关系允许赞助商使用建模和模拟来解决内部和外部药物开发问题(例如，最佳剂量，给药频率,特殊人群的剂量调整)。本白皮书是在E-R建模方面具有广泛经验的科学家之间的行业与政府合作的成果，作为监管提交的一部分。本白皮书的目的是就肿瘤学临床药物开发中E-R分析的首选方法以及应考虑的暴露指标提供指导。
