Division of Therapeutic Performance, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Eur J Pharm Sci. 2024 Aug 1;199:106815. doi: 10.1016/j.ejps.2024.106815. Epub 2024 May 24.
Bioequivalence determinations for locally acting dermatology drug products rely on assessing product sameness thru physicochemical composition and structure comparison, comparing the concentration of the active ingredient at the putative site of action, or comparing the clinical performance of the test (would-be generic) and reference products. Topical product action on cutaneous disease may be confounded by the action of excipients and are also subject to the inherent variability of how product may interact with the skin, including thermodynamic factors such as evaporation, spreadability, and interaction with the local environment such as heat and light and skin moisture.
局部用皮肤科药物产品的生物等效性测定依赖于通过理化组成和结构比较来评估产品的相同性，比较活性成分在假定作用部位的浓度，或比较受试（拟仿制药）和参比产品的临床性能。局部产品对皮肤疾病的作用可能会受到赋形剂的作用的影响，而且还受到产品与皮肤相互作用的固有可变性的影响，包括热力学因素，如蒸发、铺展性以及与当地环境（如热、光和皮肤湿度）的相互作用。
