Howland Robert H
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.
J Psychosoc Nurs Ment Health Serv. 2010 Jan;48(1):13-6. doi: 10.3928/02793695-20091204-07.
By law, the U.S. Food and Drug Administration (FDA) is permitted to approve generic versions of brand-name medications without necessarily requiring that research be conducted to prove them safe and effective, provided that a number of criteria are met. The most important criterion is bioequivalence. Bioavailability refers to the rate and extent to which the active ingredient is absorbed from a drug product. Maximum drug concentration (Cmax) is the parameter used to characterize the absorption rate. The area under the plasma drug concentration-time curve (AUC) is the parameter used to characterize the extent of drug absorption. Bioequivalence means that there is an equivalent rate and extent of absorption of the same active ingredient from two or more drug products. For a generic drug to be approved, both Cmax and AUC must vary only within a certain limited range compared with those for the brand name medication. Information about generic and pharmaceutical alternative drugs can be found in the Orange Book and via Drugs@FDA.
根据法律规定，美国食品药品监督管理局（FDA）在满足若干标准的情况下，有权批准品牌药的仿制药，而无需进行研究来证明其安全性和有效性。其中最重要的标准是生物等效性。生物利用度是指活性成分从药品中被吸收的速率和程度。最大药物浓度（Cmax）是用于表征吸收速率的参数。血浆药物浓度-时间曲线下面积（AUC）是用于表征药物吸收程度的参数。生物等效性意味着从两种或更多种药品中吸收的相同活性成分具有等效的速率和程度。要批准一种仿制药，与品牌药相比，Cmax和AUC都必须仅在一定的有限范围内变化。有关仿制药和药品替代药物的信息可在《橙皮书》中以及通过“FDA药品”查询。
