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唯有已在动物临床前研究中经过充分研究的化合物或治疗方法和技术,才能进行临床第Ⅰ期试验。在实际工作中,作者对临床前研究的要求是:(1)求出小鼠的LD_(50)和LD_(10);(2)证明其在小鼠中的抑制肿瘤效果,特别是在应用最广泛的小鼠移植肿瘤(其敏感性和至少对某些人体肿瘤有良好的相关关系);(3)研究治疗指数,亦即寻找最大的有效剂量间隔(MEDI);(4)研究该化合物的药物动力学及其(包括有活性的降解产物)在器官和/或组织中的分布;(5)对某些器官或组织进行肉眼和显微镜检查,甚至包括电子显微镜检查,以判断小鼠等动物接
Only phase I clinical trials have been conducted with well-studied compounds or treatment methods and techniques that have been well studied in animal preclinical studies. In practical work, the author’s requirements for preclinical studies are as follows: (1) Obtaining the LD_ (50) and LD_ (10) of mice; (2) Demonstrating its effect of inhibiting tumor in mice, especially in application (3) study the therapeutic index, ie look for the maximum effective dose interval (MEDI); (4) study the effect of this compound Pharmacokinetics and its distribution in organs and / or tissues (including active degradation products); (5) Macroscopic and microscopic examination of certain organs or tissues, including electron microscopy, to determine if the mice Animal connection