抗肿瘤药物首次临床试验起始剂量的一般考虑

General considerations on first-in-human dose estimation for anti-cancer drug clinical trials

首次临床试验起始剂量是创新药物非临床研究的重要内容。根据抗肿瘤药物研发特点,本文概述了抗肿瘤药物首次临床试验起始剂量选择所需要关注的风险因素和推荐的策略。由于所涉及风险因素方面存在较大差异,小分子药物和生物技术药物分别进行讨论。

First-in-human dose estimation is a critical part of nonclinical research and development of innovative new drugs.Based on the nature of anti-cancer drug innovation and factors to consider in risk assessment,recommended strategies for selecting first-in-human/patient doses for anti-cancer drug clinical trials are outlined.Since different modes of action and risk factors are involved,strategies for small molecules and biotechnologyderived pharmaceuticals are discussed separately.