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- How a Drug Comes to Market
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- Before a drug is made available to the American public, pharmaceutical companies must first complete three clinical phases (see below), and the FDA must review the company's comprehensive drug application.
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- The FDA's policy states that the agency must be sure the highest standards of scientific analysis have been conducted on all proposed drugs, without shortcuts in a rush to bring a new "cure" or "treatment" to market.
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- After arriving at the FDA, the data is reviewed by a number of experts with varying perspectives, including drug safety studies, manufacturing (the FDA conducts a site visit to the plant to be sure good manufacturing practices are in place), and statistical and medical data from the patients in each phase of the trials.
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- Additionally, if an adverse event occurs in another trial with a similar product, trials using the same or similar products are evaluated to determine if there is an increased risk to patients.
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- Clinical Phases
- Phase 1 studies are designed to determine the safety of the drug, and show what the common side effects of the drug may be and how the drug is absorbed by, and eliminated from, the body. Approximately 20 to 80 subjects are typically involved in this study.
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- Phase 2 studies begin if Phase 1 studies are acceptable. The goal of this phase is to see if the drug works in people who have certain diseases or conditions. Typically 12 to 300 subjects participate in the Phase 2 study.
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- Phase 3 studies begin if Phase 2 shows the drug to be effective. These studies collect more information about the safety and effectiveness of the drug while studying different dosages and populations as well as how effective the drug is in combination with other drugs. Several hundred to approximately 3,000 people participate in the Phase 3 study.
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- After a drug is approved by the FDA, it may undergo Phase 4 studies, where new information is studied, such as new populations, long-term side effects, or new dosaging.
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- New Biologic Drug Development
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- Each drug must complete the following steps in the order as outlined below:
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Adapted from information provided by the Food and Drug Administration.
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