Drug Product Development in the Pharmaceutical Industry

The process of drug development in the pharmaceutical industry is a lengthy and costly one. There are several distinct phases involved in product development and, at any point, the decision could be made to discard the product, making all of the prior work a waste of time and effort. According to the Clinical Trials Network, the entire process can take between five and 20 years.

Discovery/Target Identification

• The drug development process begins with study of the chemicals in the body that are thought to cause disease and the interaction of these chemicals with molecules that may affect them. When a molecule or group of molecules seems to show promise for controllling disease, investigating the potential to develop it into a treatment is the next step. This work is done in various settings, including pharmaceutical companies, independent laboratories and universities.

Pre-Clinical Testing

• Before a drug can be effectively tested it must be determined that there is a way to develop it into a medication that can be administered safely. The toxicity of the drug is studied at length, both in a test-tube environment as well as in living organisms. Animal studies are conducted to preliminarily assess the viability of the drug in preparation for human testing.

IND Filing

• A application for an Investigational New Drug (IND) is filed by the manufacturer with the U.S. Food and Drug Administration (FDA), which must approve the application before the drug can be tested on humans. The FDA has specific requirements for the type of data that must be made available to them to assist in their determination of whether it is safe to test the drug on human subjects. In particular, they look at the results of the animal testing, the proposed manufacturing approach and the design of the clinical trials.

Clinical Trials

• There are three phases of clinical trials during which the new drug is tested on humans. In Phase I studies, researchers evaluate the overall tolerability of the drug in a small number of healthy volunteers. Phase II studies assess the drug's effectiveness and side effects in a small number of people, perhaps several hundred, who have the condition or disease the drug is being developed to treat. According to the FDA, between 1,000 and 3,000 patients with the disease are included in Phase III trials, where much more extensive assessment of the effectiveness and safety of the drug is conducted. The three phases of testing may take up to 10 years to complete.

Drug Approval

• Once the trials have been completed, the company may submit a New Drug Application to the FDA, which includes specific information on study outcomes and proposed packaging, labeling and manufacturing. The review process is lengthy and complex, but ultimately the FDA either approves or denies the company's request to market the drug. Once approved, the pharmaceutical company may begin to market the drug and will continue to assess the drug's safety and efficacy in what are considered Phase IV clinical trials.