Development process of biological products

 KNOWLEDGE    |      2023-03-28

Generally, the development of new biological products must go through (1) laboratory research (exploration of production process route and establishment of quality control standards)( 2) Preclinical studies (pharmacological, toxicological, pharmacodynamic and other animal experiments)( 3) Health food shall pass the safety test of the tested product( 4) The drugs need to go through five stages of research work, such as phase I clinical trial (testing the safety of drugs with healthy volunteers), phase II clinical trial (small-scale Clinical Pharmacodynamics Research), and phase III clinical trial (large-scale Clinical Pharmacodynamics Research), before they can be approved for trial production. After one year of trial production, the drug must report the results of quality stability and further expanded clinical trials before applying for formal production approval.