León Research, S.L., Parque Tecnológico de León, C/ Nicostrato Vela s/n, León, Spain.
Methods Mol Biol. 2021;2296:411-421. doi: 10.1007/978-1-0716-1358-0_24.
The aim of this chapter is to describe and give an overview of the steps from the conception of an idea in the lab to reaching the market. Starting from the early discovery in the lab environment (including reverse and classical pharmacology), and briefly going over the different phases of clinical trials: Phase I, first tests in humans; Phase II, safety and efficacy; Phase III, efficacy confirmation; and Phase IV, post-authorization, in which the investigation would focus on long-term effects, completion of technical and safety sheet. Finally, a short conclusion in regard to the continuous overview and revision of drugs in the market.
本章的目的是描述并概述从实验室中的创意构思到进入市场的步骤。从实验室环境中的早期发现(包括反向药理学和经典药理学)开始,简要介绍临床试验的不同阶段:I 期,首次人体试验;II 期,安全性和疗效;III 期,疗效确认;IV 期,上市后,在此阶段将重点关注长期效应、完成技术和安全数据表。最后,简要总结市场中药物的持续监测和修订。