Guidelines for drug approval are set by the United States Food and Drug Administration.
Whenever a pharmaceutical company invents a new drug, a new drug application must be sent to the United States Food and Drug Administration. The application is reviewed thoroughly and the drug must be found safe and effective for people to consume. In order for the drug to become validated, several requirements must be met.
Three Phases Of Clinical Trials
In order for drugs to become validated, three phases of clinical trials must be conducted. Phase one determines how the drug is metabolized. During the trial, the optimal dose involves fewer than 100 people. Researchers can find the proper dose of the product. During the second trial, safety, effectiveness and side effects are evaluated. The final clinical trial determines if the drug is effective and examines the long-term safety and efficacy of the drug. Thousands of patients across the nation are involved in the trials.
Toxicology Testing
To determine the potential risks a new drug poses to the environment and humans, toxicology and safety testing must be conducted. The tests involve the use of tissue cultures and animals to observe the relationship between factors such as frequency of administration and long-term survival of living organisms. Testing provides information on the dose response pattern of the drug and toxic effects associated with it.
Label and Drug Sample Review
When the required clinical trials are completed the drug sponsor must submit another drug application. to the Center for Drug and Evaluation Research. Labels for the drug and samples must be reviewed. The drug has to be approved for marketing. Since this is the final stage of approval for the new drug, marketing, production, advertising, and distribution can begin.
Tags: become validated, clinical trials, determines drug, Drug Administration, drug application, Food Drug, Food Drug Administration
