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It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 [25] for the treatment of obesity. Sibutramine is reported to be a prodrug to two active metabolites , desmethylsibutramine (M1; BTS-54354) and didesmethylsibutramine (M2; BTS-54505), with much greater potency as monoamine reuptake inhibitors.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
An orexigenic, or appetite stimulant, is a drug, hormone, or compound that increases appetite and may induce hyperphagia.This can be a medication or a naturally occurring neuropeptide hormone, such as ghrelin, orexin or neuropeptide Y, [1] [2] which increases hunger and therefore enhances food consumption.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance (PDF), U.S. Department of Health and Human Services, Food and Drug Administration, April 1996 ICH E9 Guidance for Industry - E9 Statistical Principles for Clinical Trials (PDF), U.S. Department of Health and Human Services, Food and Drug Administration, September 1998 NCI
An OTC drug will help patients get treatment more quickly. Dr. Pearlman says it can often take months to get an appointment with a healthcare provider who can prescribe the medications commonly ...
A specific, and especially heavily regulated, type of medical human subject research is the "clinical trial", in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people.
The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws enacted by the Federal Government in the twentieth century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it ...