抗结核药物药效学非临床研究技术指南

Technical guidelines for preclinical pharmacodynamic study of new antituberculosis agents

研发新型抗结核药物极具挑战性,难度大,周期长,非临床研究的数据是开展临床试验的前提。全面充分的结核分枝杆菌体外和在动物体内的药效学评价是临床试验前的重要步骤和关键内容。本技术指南主要适用于治疗由结核分枝杆菌引起的肺结核病药物的研发,旨在为创新抗结核药物的临床前药效学研究提供参考。

The development of new anti-tuberculosis drugs is extremely challenging, difficult and timeconsuming. Non-clinical research data is the basis for conducting clinical trials. Comprehensive and adequate pharmacodynamic evaluation of Mycobacterium tuberculosis in vitro and in animals is an important step and key content before clinical trials. This technical essentials are mainly applicable to the research and development of drugs for the treatment of pulmonary tuberculosis caused by Mycobacterium tuberculosis, and aims to provide a reference for the preclinical pharmacodynamic research of innovative anti-tuberculosis drugs.