Newell D R
Cancer Research Unit, University of Newcastle upon Tyne, England, United Kingdom.
Hematol Oncol Clin North Am. 1994 Apr;8(2):257-75.
Recent developments in Phase I trial methodology are reviewed. Preclinical pharmacological studies can be used in Phase I trials to improve patient selection, starting dose identification, and dose escalation. Establishing pharmacokinetic-pharmacodynamic relationships is also an important new aspect of Phase I trial methodology; these relationships can be exploited in subsequent efficacy studies. Finally, the inclusion of molecular pharmacodynamic studies in Phase I trials is increasing with a view to identifying the mechanism of action of a new agent in patients.
本文综述了I期试验方法学的最新进展。临床前药理学研究可用于I期试验，以改善患者选择、起始剂量确定和剂量递增。建立药代动力学-药效学关系也是I期试验方法学的一个重要新方面；这些关系可在后续疗效研究中加以利用。最后，I期试验中纳入分子药效学研究的情况日益增多，目的是确定新药在患者体内的作用机制。
