比较局部用药物制剂的生物利用度和/或生物等效性的皮肤药代动力学方法。
Cutaneous Pharmacokinetic Approaches to Compare Bioavailability and/or Bioequivalence for Topical Drug Products.
机构信息
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
出版信息
Dermatol Clin. 2022 Jul;40(3):319-332. doi: 10.1016/j.det.2022.02.007.
The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. Pharmacokinetics-based approaches characterize the rate and extent to which an active ingredient becomes available at or near its site of action in the skin. Such methodologies are considered to be among the most accurate, sensitive, and reproducible approaches for determining the BA or BE of a product.
生物等效性（BE）的评估涉及在一项研究中比较测试产品与其参比产品，该研究的基本科学原理允许推断产品的临床性能。已经讨论和开发了几种测试方法来评估局部生物利用度（BA）和 BE。基于药代动力学的方法描述了活性成分在皮肤的作用部位或附近可获得的速度和程度。这些方法被认为是确定产品的 BA 或 BE 最准确、最敏感和最可重复的方法之一。
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