What are the requirements for the safety testing of drugs?

In West Virginia, pharmaceutical law requires that all drugs are tested for safety before they can be sold in stores or administered to patients. The safety testing process begins with preclinical testing, which involves testing the drug on animal models. During this phase, scientists gather data on how the drug affects the body, such as how it is absorbed into the blood stream and where it circulates in the body. After preclinical testing is complete, the drug moves on to clinical trials. Clinical trials involve testing the drug on human subjects, typically in three phases. The first phase tests the drug’s safety and effectiveness in a limited number of healthy individuals. The second phase tests the drug on a larger population, and measures the safety and effectiveness in those with the illness the drug is intended to treat. The third phase involves a larger population and measures the efficacy of the drug and any long-term risks. Finally, once the clinical trials are complete, the drug’s manufacturer submits the data to the FDA. The FDA reviews the data and reviews the potential risks and benefits of the drug. If the drug passes the FDA’s review process, it is approved for sale in stores and for administration to patients. In sum, pharmaceutical law in West Virginia requires that all drugs be tested for safety before they can be sold or administered to patients. This safety testing process involves preclinical testing on animal models and clinical trials with human subjects. The data from these tests is reviewed by the FDA, which then approves the drug for sale or administration if it passes the review process.

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