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In 2010, the research and development cost of each new molecular entity was about US$1.8 billion. [7] In the 21st century, basic discovery research is funded primarily by governments and by philanthropic organizations, while late-stage development is funded primarily by pharmaceutical companies or venture capitalists. [8]
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Drug Research is abstracted and indexed in: . Biological Abstracts; Chemical Abstracts; Excerpta Medica; Index Medicus; Nuclear Science Abstracts; According to the Journal Citation Reports, it has a 2014 impact factor of 0.701, ranking it 121st out of 157 journals in the category "Chemistry, multidisciplinary" [1] and 229th out of 254 journals in the category "Pharmacology & Pharmacy".
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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.
A drug is any chemical substance ... Drugs is an international treaty brought about in 1961 to prohibit the use of narcotics save for those used in medical research ...
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.