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combination drug : ウィキペディア英語版
combination drug
A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.〔Roger Collier,"Reducing the “pill burden”"(), CMAJ February 7, 2012 vol. 184 no. 2 First published January 9, 2012, doi: 10.1503/cmaj.109-4076.〕 Terms like "combination drug" or "combination drug product" can be common shorthand for a FDC product (since most combination drug products are currently FDCs), although the latter is more precise if in fact referring to a mass-produced product having a predetermined combination of drugs and respective dosages (as opposed to ''customized'' polypharmacy via compounding〔"5-in-1 PolyPill Treatment May Prevent Heart Disease"(), BAYVIEW PHARMACY'S PRESCRIPTION COMPOUNDING BLOG,Apr 01, 2009 @ 08:09 AM.〕). And it should also be distinguished from the term "combination product" in medical contexts, which without further specification can refer to products that combine different ''types'' of medical products - such as device/drug combinations as opposed to drug/drug combinations.〔(Combination Products-U.S. Food and Drug Administration )〕 Note that when a combination drug product (whether fixed-dose or not) is a "pill" (i.e., a tablet or capsule), then it is also a kind of "polypill" or combopill.
Initially, fixed-dose combination drug products were developed to target a single disease (such as with antiretroviral FDCs used against AIDS). However, FDCs may also target multiple diseases/conditions, such as Caduet (atorvastatin/amlodipine) or Exforge (amlodipine/valsartan). In cases of FDCs targeting multiple conditions, such conditions might often be related — in order to increase the number of prospective patients who might be likely to utilize a given FDC product. This is because each FDC product is mass-produced, and thus typically requires having a critical mass of potentially applicable patients in order to justify its manufacture, distribution, stocking, etc.
== Advantages ==
In addition to simply being a means of facilitating the general advantages of combination therapy, specific advantages of fixed-dose combination (FDC) drug products include:
*Improved medication compliance by reducing the pill burden of patients. Note that pill burden is not only the number of pills needing to be taken, but also the associated burdens such as keeping track of several medications, understanding their various instructions, etc.
*Ability to compose combined profiles of for example pharmacokinetics, effects and adverse effects that may be specific for the relative dosages in a given FDC product, providing a simpler overview compared to when looking at the profiles of each single drug individually. Such a combined profile can also include effects caused by interaction between the individual drugs that may be omitted in individual drug profiles.
*Since FDCs are reviewed by regulating agencies (such as the Food and Drug Administration in the United States), the active ingredients used in the FDCs are unlikely to exhibit adverse drug interactions with each other. However, FDCs may interact with other drugs that a patient is taking, so the usual medical and pharmaceutical precautions against drug-drug interactions or DDIs remain warranted.
*FDC drug products may be developed by a pharmaceutical company as a way to in effect extend proprietary rights and marketability of a drug product. Since FDCs may be protected by patents, a company may obtain exclusive rights to sell a particular FDC or formulation thereof, even though the individual active ingredients and many therapeutic uses thereof may be off-patent.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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