[Research progress on identification and quality control of Cervi Cornu Pantotrichum].

Cervi Cornu Pantotrichum, as a traditional Chinese medicine, has great potential for development. However, the identification and quality control system is not perfect, leading to the market chaos and chronic slow growth in deep processing of Cervi Cornu Pantotrichum. This paper gives an overview of present situation in identification and quality control system of the Cervi Cornu Pantotrichum, and analyzes present problems. Based on these results, the feasibility study scheme in identification and quality control system for Cervi Cornu Pantotrichum would be then put forward, providing ideas to establish its comprehensive evaluation system.

Frequency estimator for assessing of follow-on biologics.

For approval of generic drugs, the U.S. Food and Drug Administration (FDA) requires the evidence of bioequivalence in average bioavailability be provided. This is based on the Fundmental Bioequivalence Assumption from FDA that if two drug products are shown to be bioequivalent, it is assumed that they are therapeutically equivalent and can be used interchangeably. Recently, there are a few statistical considerations for assessing biosimilarity. In this article, we propose a new method based on a frequency estimator to evaluate biosimilarity; the large sample properties of the estimator, the power analysis, and calculation of the sample size are considered. Under a three-arm parallel design, the power comparison between the frequency estimator method and the other existing methods is studied through simulation, and the statistical test based on the proposed method is more powerful than for the other two methods. Simultaneously, we compared the relative performance of the three methods, and the empirical consistency and inconsistency probability are obtained in evaluating the biosimilarity.