ABSTRACT
OBJECTIVE To provide scientific basis for establishing the evaluation index system of professional and specialized drug inspectors in China. METHODS Through the method of literature research， group discussions and behavioral event interview， combined with the practice situation of drug inspection at home and abroad， in accordance with the requirements of Chinese laws and regulations and department rules， the evaluation indexes for drug inspectors were extracted and screened. In addition， the Delphi method was used to conduct correspondence with experts in relevant fields so as to determine the evaluation index system of drug inspectors. RESULTS & CONCLUSIONS Finally， 62 experts completed two rounds of anonymous online questionnaires， including 29 experts in the first round and 33 experts in the second round. The questionnaire recovery rates were 96.67% and 94.29% respectively， and the expert authority coefficients were 0.81 and 0.79， indicating a high level of authority among experts. After expert consultation， evaluation index system for professional and specialized drug inspectors had been constructed， including five first-level indexes （personal characteristics， professional knowledge， professional skills， professional behavior and professional ethics） and their corresponding 27 second-level indexes. The average score of the importance of second-level indexes was 4.224- 4.879， the full score ratio was 81.8%-100%， the coefficient of variation was 0.067-0.177， and Kendall’s W was 0.643 （P＜0.001）. It indicates that this evaluation index system is relatively reliable and is expected to become a management tool for promoting the construction of professional and specialized drug inspector team and ensuring the quality of drug inspection.
ABSTRACT
Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.
ABSTRACT
This proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies. It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS). The 0.3sigma test is used to evaluate the homogeneity and stability of the proficiency testing sample. The results of the laboratories were assessed by Z-score. The robust average and the robust standard deviation of the participants' results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics. Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back. Twenty-four laboratories' results were observed as satisfactory. Five laboratories were identified as having reported at least one questionable result. Four laboratories were identified as having reported at least one unsatisfactory result.
ABSTRACT
BACKGROUND: Appropriate seed cell is important for transplantation in the treatment of cerebrovascular disease and other central nervous system disease.OBJECTIVE: To investigate the capacity of human adipose tissue-derived stromal cells (ADSCs) to differentiate into neurons.METHODS: The fatty tissue was harvested from removed abdominal unnecessary fat of healthy adult with no communicable disease or endocrine disease. Human ADSCs were isolated from human liposuction tissues and cultured in neural induction medium with GM1. Invert phase-contrast microscopy was used to observe morphology changes of ADSCs. The expression of nestin, neuron specific enolase (NSE) and microtubule-associated protein 2 (MAP2) were identified by immunocytochemistry.RESULTS AND CONCLUSION: The majority of cells displayed typical appearance of neuronal-like cells following induction. Following 1 hours of induction, some cells began to express nestin, and NSE and MAP2-positive cells were observed at 5 hours. ADSCs can differentiate into neurons, and the differentiated neurons have the capacity of expressing nestin, NSE and MAP2.