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Biologic medical product : ウィキペディア英語版
Biopharmaceutical
A biopharmaceutical, also known as a biologic(al) medical product, biological,〔http://www.oxforddictionaries.com/us/definition/english/biological〕 or biologic, is any medicinal product manufactured in, extracted from, or semisynthesized from biological sources. Different from chemically synthesized pharmaceuticals, they include vaccines, blood, or blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They are isolated from natural sources—human, animal, or microorganism.
Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological medicinal products'' or ''therapeutic biological product'' to refer specifically to engineered macromolecular products like protein- and nucleic acid–based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source. Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics.〔〔(【引用サイトリンク】 title=Specialty Pharmacy Managed Care Strategies )
Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
In some jurisdictions, biologics are regulated via different pathways than other small molecule drugs and medical devices.
The term biopharmacology is sometimes used to describe the branch of pharmacology that studies biopharmaceuticals.
==Major classes==


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「Biopharmaceutical」の詳細全文を読む



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