Wang Rong, Conner Dale P, Li Bing V
Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
AAPS J. 2017 Mar;19(2):360-366. doi: 10.1208/s12248-016-0025-9. Epub 2016 Dec 21.
Oral modified-release (MR) products are dosage forms administered through the mouth and designed to release drug in a controlled manner to achieve maximum efficacy, minimal side effects, and better patient compliance. With significant progress in pharmaceutical technologies and favored therapeutic benefit, more and more oral MR products including the generic versions of these products are being developed, marketed, and used in the USA. Because different types of MR products may exhibit unique drug release modes and specific pharmacokinetic profiles, a better understanding of the regulation and evaluation of these generic MR products can help development and marketing of generic MR products that are therapeutically equivalent to the corresponding reference product. This review summarizes the general regulatory requirements for establishing bioequivalence between generic and reference oral MR products. In addition, some special regulatory considerations for bioequivalence evaluation are highlighted with examples of specific oral MR drug products.
口服缓释（MR）制剂是通过口腔给药的剂型，旨在以可控方式释放药物，以实现最大疗效、最小副作用和更好的患者依从性。随着制药技术的显著进步以及所带来的有利治疗效果，越来越多的口服MR制剂，包括这些产品的仿制药，正在美国进行研发、上市和使用。由于不同类型的MR制剂可能表现出独特的药物释放模式和特定的药代动力学特征，更好地理解这些仿制药的监管和评估有助于开发和销售在治疗上与相应参比制剂等效的仿制药。本综述总结了仿制药与参比口服MR制剂之间建立生物等效性的一般监管要求。此外，还以特定口服MR药品为例，强调了生物等效性评估中的一些特殊监管考量。
