Name: Le Thu Trang Class: K13D6A Drug Development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery It includes: Novel chemical compounds; Preclinical testing; clinical trial and Approve a new drug This picture above/ below summarizes/ illustrates/ shows/ indicated/ reveals/ unveils + stages of a typical drug discovery and development Novel chemical compounds is the first step in the Drug development process Substances and compounds may be obtained from Plants, animal tissues, microbial cultures or by means of gene technology About 10,000 substances and compounds synthesized from various sources In drug development, preclinical development, also termed preclinical testing, is a stage of research that begins before clinical trials (testing in humans) Preclinical trials studying the mechanism of action, activity, effects, toxicity of compounds on cells and physiological functions of organs by testing on animals ( Rabitt, mouse, frog, ), isolated organs and cells During this process, iterative testing and drug safety data are collected, from which about 10000 substances agents select about 10 substances for human testing Clinical testing advance through phases to test a treatment, find the appropriate dosage and look for side effects Phase studies on healthy subjects to determine the dose, pharmacokinetics and effects of the drug on body functions Unlike phase 1, phase studies on selected patients to determine effects on disease, safety, efficacy, dose, pharmacokinetics The significance of phase is to see if the drug makes sense and reduces the clinical manifestations of the biochemical parameters of disease This phase can last several years Phase studies on group patients with the aim of comparing with standard therapy ( comparing the treatment result of the conventional method with the new treatment, whether it is more effective) Initially from 10000 substances through all stages choose the most optimal one Next step is drug approval: FDA will review the records to see if the drugs have been adequately tested If the FDA agrees that the test result is positive, it will approve the drug Phase 4: after being approved by the FDA, the drug may be marketed under a trade name according to the doctor's prescription or the pharmacist’s prescription A device or drug’s effectiveness and safety are monitored in large, diverse population Phase will monitor for side effects and assess whether the drug is beneficial or harmful