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What is the drug development industry?

Drug development is a major part of the pharmaceutical industry. It is the process of bringing new drugs to the market. It follows the phase of drug discovery. Once a lead compound has been identified and the process goes into pre-clinical research. After this step, but still, within drug development, you have the clinical phase.

 

The pre-clinical phase consists of research on microorganisms and animals. But also filing for regulatory status with the FDA or EMA. They will assess safety, toxicity, pharmacokinetics, and metabolism prior to human clinical trials.

 

In the pre-clinical phase, you also have the processes known as chemistry, manufacturing, and control (CMC). The first C stands for verification of chemical makeup, stability, and solubility. The M stands for the optimization of the manufacturing process to scale up production from milligrams to tons. The second C stands for the further examination of suitability to package as capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, or intravenous formulations.

 

Once approved, the drug can be tested on humans in clinical trials. These trials are conducted in hospitals by unbiased physicians and their staff of clinical personnel. Clinical trials consist of 4 phases. To go from one phase to another, you need to get approval from the regulatory authorities (FDA or EMA). Phase I is done on healthy volunteers to check safety and dosing. In Phase II they will check efficacy and safety in a small number of patients. Phase III will expand the trial to a large number of patients.

 

Drug discovery is the most expensive part of bringing a new drug to market. For large companies, the costs may skyrocket up to more than 5 billion dollars for a single drug.

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