How does the development of new drugs work?

The R&D process involves many steps such as drug design and screening, chemical synthesis and modification, pharmacy and pharmacokinetic studies, process and formulation, quality testing and control, safety and clinical evaluation, market feedback and so on, and the problems faced are complex.

According to the different contents of the work, new drug development can be divided into four stages: discovery and screening, preclinical research, clinical research, new drug declaration and follow-up work.

First, discovery and screening includes basic and applied research (including drug preparation and initial screening), discovery and screening of drug sources.

Second, preclinical research includes experimental and animal testing and its preparation in order to determine the safety and efficacy of the drug, both pharmacology, efficacy, pharmacology and toxicology and clinical declaration.

Third, clinical research includes I (preliminary clinical pharmacology, human safety studies), II (preliminary evaluation of the therapeutic effect, safety studies, phase III clinical trials and their preparations (expanded clinical trials, special clinical trials, additional clinical trials, adverse reaction observation).

Fourth, the declaration of new drugs and follow-up work includes the declaration of new drugs, as well as due to the SFDA (State Food and Drug Administration) to review the declaration of new drugs required to do additional work.