Drug development

Step 1 is known as Discovery and Development. Researchers can discover new drugs through a variety of ways, including new insights into a disease process, tests of molecular compounds, existing treatments with an anticipated effects and new technologies. Once a promising compound has been discovered further experiments are required to gather data on how the compound is absorbed, distributed, metabolized, excreted, mechanisms of action, dosage, administration, toxicity, how it affects different groups of people, drug interactions and its effectiveness. This leads to Step 2 where the compound is tested in preclinical research. During Step 2 research establish the compounds dosing and toxicity via in Vitro and in Vivo testing which must be carried out in line with the good laboratory practices (GLP). Providing the compound is safe to use it is tested in humans, this is Step 3 Clinical Research.

Researchers design clinical trials to answer specific research questions and follow a protocol which has been developed by the researcher. There are 4 phases to clinical research studies. Phase I studies a designed to assess the safety and dosage of the drug in 20–100 healthy volunteers or people with the disease. Phase II studies can include several hundred people with the disease and assess the efficacy and side effects of the drug. Phase III studies can last between 1 to 4 years investigating the efficacy and side effects in 300–3000 volunteers with the disease. The final clinical trial is Phase IV which includes several thousand volunteers with the disease and aims to further assess safety and efficacy. Step 4 is where the FDA review all of the submitted data and decide whether to approve or not approve the drug. Providing a drug is approved for us, Step 5 involves the FDA monitoring the drug’s safety whilst being used by the public.