Schwartsmann G, Winograd B, Pinedo H M
Department of Oncology, Free University Hospital, Amsterdam, The Netherlands.
Radiother Oncol. 1988 Aug;12(4):301-13. doi: 10.1016/0167-8140(88)90020-5.
The development of new anticancer agents is a long-term process, which involves the acquisition of new compounds, screening for antitumor activity, production and formulation, animal toxicology and finally, evaluation of toxicity and antitumor activity of the compound in man (Table I). In this paper, the main steps in the early development of new cytotoxic agents up to phase II clinical studies will be discussed. However, clinical phase III-IV trails, where the efficacy of the drug has been proven, should be dealt with separately.
新型抗癌药物的研发是一个长期过程，涉及新化合物的获取、抗肿瘤活性筛选、生产与制剂、动物毒理学，最终还包括该化合物在人体中的毒性和抗肿瘤活性评估（表I）。本文将讨论新型细胞毒性药物早期研发直至II期临床研究的主要步骤。然而，已证明药物疗效的III - IV期临床试验应单独论述。
