What stages do drug research and development need to go through?

The first step is to establish the research direction and determine the medical function, main components, dosage forms and market value of the product. \x0d\ Part II, consult the literature to collect relevant information, and pay attention to avoid infringing others' patents. \x0d\ Step 3, open the topic, collect and sort out the data, open the topic, apply for funds, and prepare for research and development. \x0d\ The fourth step is the exploration of prescription and technology, during which a lot of experiments have been started, including the quality research of raw materials, the screening of key parameters of preparation technology, and the rationality of prescription ratio. \x0d\ Step 5: Carry out pilot production and process amplification (whether amplification is needed depends on the production difficulty), and conduct quality research on the products. \x0d\ Step 6, Phase I clinical trial (please refer to the Administrative Measures for Drug Registration for details according to the registered categories, and this step can be omitted) \x0d\ Step 7, optimize the product process, scale up in batches, carry out three batches of continuous mass production, and verify the process at the same time. \x0d\ Step 8: Conduct quality research and stability test on products, establish quality standards and conduct methodological verification. \x0d\ Step 9: Collect verification data, pharmaceutical research data and literature data. After summarizing, sort out the application materials for drug registration. \x0d\ Step 10: The superior competent department (US Food and Drug Administration) sends people to inspect the process and take samples at the same time. \x0d\ Step 11: After the approval, the Food and Drug Administration will start to review the varieties. After the approval, it can issue approval documents and agree to production. Complete drug research and development and registration. \x0d\ However, phase III clinical trial, follow-up drug stability study and adverse reaction detection are still needed. \x0d\x0d\ If it is simpler, it is mainly divided into: \ x0d \ literature review in the early stage of research and development, prescription process exploration, laboratory small-scale and pilot-scale amplification (1 phase clinical trial is needed for new drugs at this time), process verification and quality research, application data summary, SFDA on-site verification, and production approval after approval.