WHAT DRUG DEVELOPMENT IS

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 pre-clinical research on microorganisms and animals, filing for regulatory status for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.

The process of drug development can be divided into pre-clinical and clinical work.

DISCOVERY

Typically, researchers discover new drugs through:

• New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease.
• Many tests of molecular compounds to find possible beneficial effects against any of a large number of diseases.
• Existing treatments that have unanticipated effects.
• New technologies, such as those that provide new ways to target medical products to specific sites within the body or to manipulate genetic material.

At this stage in the process, thousands of compounds may be potential candidates for development as a medical treatment. After early testing, however, only a small number of compounds look promising and call for further study.

DEVELOPMENT

Once researchers identify a promising compound for development, they conduct experiments to gather information on:

• How it is absorbed, distributed, metabolized, and excreted.
• Its potential benefits and mechanisms of action.
• The best dosage.
• The best way to give the drug (such as by mouth or injection).
• Side effects or adverse events that can often be referred to as toxicity.
• How it affects different groups of people (such as by gender, race, or ethnicity) differently.
• How it interacts with other drugs and treatments.
• Its effectiveness as compared with similar drugs.