|
thumb A pharmaceutical drug (also referred to as a pharmaceutical, pharmaceutical preparation, pharmaceutical product, medicinal product, medicine, medication, medicament, or simply a drug) is a drug used to diagnose, cure, treat, or prevent disease.〔 Accessed 30 December 2013.〕〔(US Federal Food, Drug, and Cosmetic Act, SEC. 210., (g)(1)(B). ) Accessed 17 August 2008.〕〔 Published 31 March 2004. Accessed 17 August 2008.〕 Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in various ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, and cell therapy (for instance, stem cell therapies). Other ways to classify medicines are by mode of action, route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps a list of essential medicines. Drug discovery and drug development are complex and expensive endeavors undertaken by (industry|pharmaceutical companies )], academic scientists, and governments. Governments generally regulate what drugs can be marketed, how drugs are marketed, and in some jurisdictions, drug pricing. Controversies have arisen over drug pricing and disposal of used drugs. ==Definition== In Europe, the term is "medicinal product", and it is defined by EU law as: "(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."〔( Directive 2004/27/EC ) Official Journal of the European Union. 30 April 2004 L136〕 In the US, a "drug" is: * A substance recognized by an official pharmacopoeia or formulary. * A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. * A substance (other than food) intended to affect the structure or any function of the body. * A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. * Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)〔FDA (Glossary )〕 抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Pharmaceutical drug」の詳細全文を読む スポンサード リンク
|