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...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.展开更多
Recently, a class of non-primitive cyclic codes with two nonzeros have received much attention of researchers and their weight distributions have been obtained for several cases of two key parameters related to the no...Recently, a class of non-primitive cyclic codes with two nonzeros have received much attention of researchers and their weight distributions have been obtained for several cases of two key parameters related to the nonzeros. In this paper, by evaluating certain Jacobi sums, we determine the weight distributions of this class of cyclic codes for one more special case.展开更多
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。
文摘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.
基金supported by National Natural Science Foundation of China(Grant Nos.11101131 and 61170257)National Basic Research Program of China(Grant No.2013CB834203)the External Science and Technology Cooperation Program of Hubei Province(Grant No.2012IHA01402)
文摘Recently, a class of non-primitive cyclic codes with two nonzeros have received much attention of researchers and their weight distributions have been obtained for several cases of two key parameters related to the nonzeros. In this paper, by evaluating certain Jacobi sums, we determine the weight distributions of this class of cyclic codes for one more special case.
