INVESTIGATIONAL NEW DRUGS Meaning and
Definition
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Investigational New Drugs (IND) refers to pharmaceutical compounds or substances that are under evaluation or clinical investigation for their potential use as medications or therapies. An IND is a status granted by regulatory authorities, such as the U.S. Food and Drug Administration (FDA), to allow researchers or pharmaceutical companies to conduct clinical trials and gather data on the safety and effectiveness of a new drug.
An IND application is a comprehensive document submitted to the regulatory authority, providing detailed information about the investigational compound, its chemistry, manufacturing process, preclinical studies, and proposed clinical trial design. The application also includes information on potential risks and benefits, as well as any prior research conducted on the compound. The purpose of the IND process is to ensure that the investigational drugs are rigorously evaluated for their safety and efficacy before being made available to the general public.
Once an IND is approved, the investigational drug can proceed to clinical trials, where it is administered to human subjects to assess its therapeutic effects, side effects, and dosage requirements. Different phases of clinical trials are conducted to determine the drug's pharmacokinetics and pharmacodynamics, appropriate dosage, and potential interactions with other drugs.
Overall, the designation of an investigational new drug allows researchers and pharmaceutical companies to gather crucial information about the drug's safety and efficacy prior to seeking its approval for commercialization and widespread use in the population.
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