The therapeutic equivalence of complex drugs

When the patent of a small molecule drug expires generics may be introduced. They are considered therapeutically equivalent once pharmaceutical equivalence (i.e. identical active substances) and bioequivalence (i.e. comparable pharmacokinetics) have been established in a cross-over volunteer study. However this generic paradigm cannot be applied to complex drugs as biologics and a number of other therapeutic modalities. For copies of biologics the European Medicine Agency and other regulatory agencies have introduced a new regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. However for other complex drugs such as the iron-carbohydrate drugs, low molecular weight heparins (LMWHs), liposomal drugs and the glatiramoids regulatory guidance is still mostly lacking. In this paper we will discuss (therapeutic) experience obtained so far with these different classes of 'complex drugs' and their specifics to provide scientific arguments and criteria for consideration for a regulatory framework for the market authorization for these type of drugs.     

Impact of community pharmacists' interventions on asthma self-management care

Background

Asthma self-management is aimed to improve the quality and effectiveness of asthma care by supporting the patients to manage their illness by themselves.

浅谈接受美国FDA现场检查的体会

本文介绍了美国FDA现场检查的目的和检查程序,讲解了FDA现场检查的迎审对策,包括现场检查的基本原则,文件和现场准备,有效组织迎审团队,认真研究审核思路,加强GMP意识培养,历史检查问题的整改。     

Pharmacy student’s perceptions,behaviours and attitudes toward virtual reality simulation

AimsThe definition of virtual reality simulation (VRS) used for study is the recreation of realistic simulation in a fully online situation with an immersive environment for learning an activity. The study aims to evaluate pharmacy students’ perspectives, behavioral and attitude characteristics in the process of VRS course requiring practical skills.Materials and methodsThis cross-sectional study was based on quantitative questionnaires analysis. A five-point Likert Scale (rating from 1 = Strongly Disagree; 2 = Disagree; 3 = Neutral; 4 = Agree; 5 = Strongly Agree) was utilized to measure the extent to which the students agrees on 30 statements comprised in A-E sections related to VRS. The validity and reliability of the questionnaire were studied by the Cronbach’s Alpha calculation.ResultsA total of 119 junior and senior pharmacy students, aged 18–25, participated in this study. There is no significant gender difference (P > 0.05) and grade difference (P > 0.05) in mean perception score, mean attitude score, mean behavior score and comparison score respectively. Most pharmacy students had positive perception that VRS could help them in practical ability (61.4 %), autonomous learning (68.9 %) and theoretical knowledge (61.4 %). Nevertheless, less than half the students agreed that VRS courses were indispensable (44.5 %) and needed to be increased (42.9 %). Moreover, the ‘disagree’ statement (33.6 %) exceeded ‘agree’ statement (27.7 %) about the question of whether preferring VRS courses to lab teaching. Interestingly, a significant positive correlation that was observed between mean perception score and mean attitude score (r = 0.76, p < 0.001), mean comparison (r = 0.68, p < 0.001) and mean behavior (r = 067, p < 0.001), which revealed that students who thought VRS was beneficial were more likely to accept it.ConclusionThe study highlights the need to establish an interactive, immersive and measurable VRS courses. It is suggested that good interaction between the faculty and student, technology improvement and blended programmatic assessment should be involved in challenges for implementing VRS courses.     

新药临床等效性分析方法及其评价

临床等效性检验是临床试验中评价新药疗效的一种方法，用于比较两药的疗效是相当，它弥补了和一物等效性评价的不足之处，目前已被推广使用，本论述了临床等效性评价中等效果值确定方法，临床终点的选取，试验设计，统计分析等一些关键性问题，并分析了其研究现状，这对于临床等效性评价方法的正确应用与发展有现实意义。     

从临床疗效角度谈原研药和仿制药的区别

目的:从临床疗效的角度对原研药与仿制药的区别进行介绍并探讨引起疗效差别可能的原因。方法:在ISI Web of Knowledge、PubMed、Science Direct和中国知网数据库中检索原研药与仿制药对比的相关中英文文献,并对文章进行分析。结果:通过对检索到的相关文献进行分析,我们发现在癫痫、帕金森、精神疾病、器官移植、心血管和感染疾病方面的仿制药与原研药相比存在一定差异。结论:对于部分药物而言,作为评价仿制药上市的标准——生物等效性(bioequivalence,BE)试验尚不能替代临床疗效的等效性。制剂因素是两种药品疗效差异的根本原因。     

美国FDA生物等效性指导原则的修订与仿制药一致性评价

目的 介绍中国药学会翻译的美国FDA《特定药物的生物等效性指导原则》中涉及289目录的185个品种，从2016年6月至今的BE试验指导原则的更新情况，作为对已发布的中文翻译稿的补充。方法 在FDA网站上对相关品种逐一进行检索，研究和分析有修订的10个品种和新增的2个品种的BE试验指导原则发生更新的可能原因。结果与结论 美国FDA《特定药物的生物等效性指导原则》一直处于持续更新状态。在我国开展仿制药质量与疗效一致性评价的工作中，业内人士应密切关注其更新情况，及时获得最有价值的参考信息。     

Pharmacists' perceptions and communication of risk for alertness impairing medications

Background

A core role of the pharmacist is to ensure safe and effective medication use. Therapeutic classes that impair alertness (e.g. sedatives or hypnotics) can pose safety concerns for the consumer when undertaking activities requiring psychomotor vigilance (e.g. driving).

Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac® and Exodol®

The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol^® and Dolac^®, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma-concentration-against-time curves were constructed. Maximal plasma concentration and AUC_0-24. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for C_max and from 85 to 118% for AUC_0-24. It is concluded that the two assayed formulations are bioequivalent.     

美国药品监管人员培训模式分析及其对我国的启示

目的:为发展和完善我国药品监管人员培训制度提供建议。方法:介绍美国法规事务办公室大学的具体运作模式,分析中美两国药品监管人员培训模式的差别。结果与结论:美国药品监管人员培训现已建立了系统、连续、统一的体系,较之我国有一定的灵活性、先进性。我国可借鉴美国的相关经验,在我国药品监管人员培训统一性、预算机制以及培训方式多样化等方面作出相关改进。     

社区用药安全支持系统的设计与应用

目的:建立社区用药安全支持系统,实现优质药学服务对社区的延伸和覆盖。方法:利用计算机网络技术和数据库技术,整合各类药学信息并进行再处理,实现对内、对外药学信息服务的相关应用。结果:该系统运行稳定,维护方便及时,可提供多种社区药学服务。结论:社区用药安全支持系统的建立为医院药师与社区医务工作者及患者提供了一个方便、迅速的交流平台,对社区用药安全及合理用药水平的提高起到推进作用。     

Drug counselors' perceptions of clients: Demographic,personality and psychopathology correlates

Counselors' interpersonal perceptions of their clients in outpatient drug treatment were studied. Factor analysis produced three general factors, interpreted as perceptions of manageability, treatment readiness, and suitability for group treatment. Counselor perception of client interpersonal attractiveness did not emerge as a separate factor, but appeared equally significantly related to each of the first two factors. Correlates of counselor perceptions were sought among measures of client program performance, demographic and drug use history, psychopathology, and counselor background and personality. With one exception, measures of clients' actual program performance were the best predictors of counselors' perceptions of clients. Clinical implications are discussed.