Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the sim...Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.展开更多
In this paper,we focus on the following coupled system of k-Hessian equations:{S_(k)(λ(D^(2)u))=f_(1)(|x|,-v)in B,S_(k)(λ(D^(2)v))=f2(|x|,-u)in B,u=v=0 on■B.Here B is a unit ball with center 0 and fi(i=1,2)are cont...In this paper,we focus on the following coupled system of k-Hessian equations:{S_(k)(λ(D^(2)u))=f_(1)(|x|,-v)in B,S_(k)(λ(D^(2)v))=f2(|x|,-u)in B,u=v=0 on■B.Here B is a unit ball with center 0 and fi(i=1,2)are continuous and nonnegative functions.By introducing some new growth conditions on the nonlinearities f_(1) and f_(2),which are more flexible than the existing conditions for the k-Hessian systems(equations),several new existence and multiplicity results for k-convex solutions for this kind of problem are obtained.展开更多
Cycle multiplicity of a graph G is the maximum number of edge disjoint cycles in G. In this paper, we determine the cycle multiplicity of and then obtain the formula of cycle multiplicity of total graph of complete bi...Cycle multiplicity of a graph G is the maximum number of edge disjoint cycles in G. In this paper, we determine the cycle multiplicity of and then obtain the formula of cycle multiplicity of total graph of complete bipartite graph, this generalizes the result for, which is given by M.M. Akbar Ali in [1].展开更多
基金supported by the Special Foundation of Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University(2021jgkx004).
文摘Objective To study the content of China’s guiding principles on multiplicity issues in clinical trials,and to provide reference for the revision of China’s relevant guiding principles.Methods Based on ICH E9,the similarities and differences of the guiding principles of US Food and Drug Administration(FDA),European Medicines Agency(EMA),and National Medical Products Administration(NMPA)on the multiplicity issues in clinical trials were compared one by one.Results and Conclusion In general,NMPA guidelines are based on ICH E9,but in detail,the guidelines of FDA and EMA focus differently on the multiplicity issues.Therefore,NMPA guidelines need to be detailed and comprehensive.NMPA guidelines can be refined by referring to foreign guidelines to improve the practical guiding significance for clinical research and promote the level of domestic clinical trials in line with international standards.
基金supported by the National Natural Science Foundation of China (11961060)the Graduate Research Support of Northwest Normal University (2021KYZZ01032)。
文摘In this paper,we focus on the following coupled system of k-Hessian equations:{S_(k)(λ(D^(2)u))=f_(1)(|x|,-v)in B,S_(k)(λ(D^(2)v))=f2(|x|,-u)in B,u=v=0 on■B.Here B is a unit ball with center 0 and fi(i=1,2)are continuous and nonnegative functions.By introducing some new growth conditions on the nonlinearities f_(1) and f_(2),which are more flexible than the existing conditions for the k-Hessian systems(equations),several new existence and multiplicity results for k-convex solutions for this kind of problem are obtained.
文摘Cycle multiplicity of a graph G is the maximum number of edge disjoint cycles in G. In this paper, we determine the cycle multiplicity of and then obtain the formula of cycle multiplicity of total graph of complete bipartite graph, this generalizes the result for, which is given by M.M. Akbar Ali in [1].
