General considerations for clinical data management of antineoplastic drugs / 中国临床药理学与治疗学

With the enormous resources having been invested in oncology drugs development in China in recent years, the Center for Drug Evaluation (CDE) of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials. As data is the cornerstone of clinical trials, data integrity and quality will directly decide the outcome of clinical studies. Given the specific characteristics of oncology therapeutic clinical trials, and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium (CDISC) and the issued industrial guidelines, this article introduces the general considerations of clinical data management for oncology clinical trials, with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study. This article discusses the impact of complex study design on CRF, design CRF according to CDASH, develop DVP scientifically, rolling submissions and data cut-off.

Optimizing the Purification Technics of the Effective Blood-fat Dropping Parts from Radix Puerariae and Fructus Crataegi by Orthogonal Test / 中国药房

OBJECTIVE:To study the feasibility of purifying the effective blood-fat dropping parts from radix puerariae and fructus crataegi and to optimize the technical conditions and parameters.METHODS:Absorption capacities of four different macroporous resins on pueraria total isoflavones,crataegi total flavonoids and crataegi total triterpenic acid were compared.With adsorption quantity as index,optimization of the technics of purifying the effective blood-fat dropping parts from radix puerariae and fructus crataegi with macroporous resins were performed.RESULTS:AB-8resin showed a best adsorbability on the effective blood-fat dropping parts from radix puerariae and fructus crataegi,its optimum purification condition was the following,the concentration of the stock solution was0.13g crude drug/ml with a flow rate at0.5ml/min,and its pH value at about3.5(the same as the stock solution);80%ethanol solution was taken as the eluting solvent at an eluting flow rate of2ml/min.The purity coefficient of the purified effective portions was above85%.CONCLUSIONS:AB-8macroporous resin could be used for the purification of the effective blood-fat dropping parts from radix puerariae and fructus crataegi,the process is feasible and the reproduction of resin is easy.