摘要
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
已批准的具有治疗性等效性评价的药品目录(俗称橙皮书)包括了美国食品药品管理局批准上市的产品,它是我国化学仿制药选择合适的参比制剂(RLD)的一个非常重要的来源。橙皮书中的多源性处方药会被分配相应的治疗等效性(TE)评价代码,作为临床药品选择的公共信息。本文以托吡酯缓释胶囊为例,介绍了TE评价代码系统及其对我国RLD选择的影响。研究结果表明,我们在选择一个RLD时,应事先确定其在橙皮书中的TE评价代码,并选择TE评价代码首字母为A的合适的RLD进行仿制药的研发,从而提高临床生物等效性试验的成功概率,降低仿制药开发的风险。
基金
Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
