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Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector最新文献

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Customers’ response to the offer of substitute brands of medicines for the prescribed ones – An exploratory study of consumer behavior in North India 顾客对处方药品的替代品牌的反应——印度北部消费者行为的探索性研究
Yogesh Kumar, Utkal Khandelwal, Ankita Saxena
Patients/customers are offered a substitute brand of medicine generally when the prescribed brand is not available at retail store. However, the customers respond in various ways to such an offer. There are many factors that affect the acceptance/rejection of the substitute brand by the customers. This study’s objective is to categorize consumers’ responses to the offer for substitute brand of medicine in place of the prescribed one in north India. Another objective of the study is to identify common characteristics of customers falling in different response categories. Researchers conducted in-depth interviews with chemists/retailers and customers. The common responses of the customers to the offer of substitute drugs were- straightway acceptance, acceptance of substitute brand after the assurance of substitute being chemically equivalent by the pharmacist and rejection of the substitute. Education, age, trust on pharmacist and perceived seriousness of illness were the main factors affecting the acceptance of substitution.
当指定品牌的药物在零售商店买不到时,一般会向病人/顾客提供替代品牌的药物。然而,客户以各种方式回应这样的报价。影响消费者接受/拒绝替代品牌的因素有很多。本研究的目的是分类消费者的反应,以提供替代品牌的药物,而不是规定的一个在印度北部。该研究的另一个目的是确定不同响应类别的客户的共同特征。研究人员对化学家/零售商和消费者进行了深入的采访。消费者对替代药品的普遍反应是:直接接受、药剂师保证替代药品化学成分相等后接受替代药品品牌、拒绝替代药品。受教育程度、年龄、对药师的信任程度和对疾病严重程度的感知是影响替代接受度的主要因素。
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引用次数: 0
Authorized generics vs. branded generics: A perspective 授权仿制药与品牌仿制药:一个视角
Bharti Latwal, A. Chandra
Nowadays, there are many generic medications available in the market. Their sale is increasing day by day due to their lower cost and affordability by most of the customers. Generic medications are pharmaceuticals that are therapeutically equivalent to an original off patent drug. Both authorized generics and branded generics are the versions of generic medications. They offer lucrative business and increase competition for ordinary generics. They supply medications having quality of branded drugs at lower prices and this establishes their recognition among the masses who earlier has limited options to buy only brand-name drugs. They are cheaper than brand name drugs but costlier than ordinary generics. Authorized generics are sold only by Innovator Companies but the branded generics can be sold by both innovator companies and generic companies. They both are different from one another and have their own impact on the brand drug companies, generic companies and consumers.
如今,市场上有许多非专利药物。由于它们的成本较低,大多数顾客都能负担得起,它们的销量日益增长。仿制药是指在治疗上与原始非专利药物等效的药物。授权仿制药和品牌仿制药都是仿制药的版本。它们提供了有利可图的业务,并增加了普通仿制药的竞争。他们以较低的价格提供具有品牌药质量的药物,这在以前只能购买品牌药的有限选择的群众中建立了他们的知名度。它们比名牌药便宜,但比普通仿制药贵。授权仿制药只能由创新公司销售,而品牌仿制药可以由创新公司和仿制药公司销售。它们彼此不同,对品牌药公司、仿制药公司和消费者都有各自的影响。
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引用次数: 2
Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh 孟加拉国地氯雷他定口腔崩解仿制片体外释药动力学统计评价及质量评价
Madhabi Lata Shuma, S. Halder
The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commercially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach (f2 > 50, f1 < 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products.
本研究的目的是比较孟加拉国药品市场上销售的地氯雷他定(DES)不同口腔崩解片(ODT)与参比品牌的体外等效性。采用美国药典(USP)桨片法进行体外溶出度研究,并与参比品牌进行对比研究。其他药典和非药典质量评价参数包括硬度、脆性、吸水率、崩解时间等。从市售产品的溶出度曲线结果来看,采用与型号无关的方法(f2 > 50, f1 < 15),大多数产品对参考品牌的溶出度行为不符合药典要求,差异具有统计学意义。此外,不同物理质量参数的数据显示,所有商业产品都符合官方规格。根据这些发现,可以建议在孟加拉国市场上提供DES-ODT配方;然而,可能需要额外的实验来澄清产品之间的互换性。
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引用次数: 0
Covid 19 – Impact and new normal for pharmaceutical industry (Part – I) 2019冠状病毒病对制药行业的影响和新常态(上)
Ranjit Barshikar
This review article shares New Normal as part of impact of Covid 19, on Pharmaceutical Industry globally as whole & Manufacturing Operations as preventive measures or cure of Covid 19. Based on known transmissions & spreading routes, the Pharmaceutical Industry Manufacturing Operations needs to learn to avoid such impacts of transmissions & spreads. The pharmaceutical and healthcare operations need to take care to protect personnel As such The Pharmaceutical Industry does take very good care to avoid cross contaminations as part of Good Manufacturing Practices (GMP). But now keeping in mind seriousness of virus spread, the Pharmaceutical Industry has to take precautions to avoid transmission & spread during travel in buses, entry & exit procedures, change rooms, avoid hand touch to doors, handles etc. at office work places & throughout the manufacturing operations at site This article looks at various stages the Pharmaceutical Manufacturing Operation sites has to take care depending types of products & human involvement in such operations As per WHO, key major steps to protect against the infection are:  • Social distancing  • Use of Masks/Face- Shields  • Frequent Washing of Hands with soap & water or Sanitisation with proper sanitisers containing min. 70% Alcohol.  • Segregation of staff in essential & non-essential at manufacturing site.  • Non-essential staff to work from home Essential staff are the ones who are required to work in person at manufacturing site The Pharmaceutical Industry is moving forward very confidently by amending concerned SOP’s to meet Covid – 19 impact & challenges. This article describes “New Normal – impacts” of Covid-19 & basic requirements like Personal hygiene, Entry/Exit procedures to Protect the Workplace & Safety of the Workforce.
这篇综述文章分享了新常态作为2019冠状病毒病对全球制药业整体影响的一部分,以及作为2019冠状病毒病的预防措施或治疗措施的制造业务。根据已知的传播和传播途径,制药行业生产运营需要学会避免这种传播和传播的影响。制药和医疗保健业务需要注意保护人员,因此制药行业确实非常注意避免交叉污染,这是良好生产规范(GMP)的一部分。但考虑到病毒传播的严重性,制药行业必须采取预防措施,避免在公共汽车旅行、出入境程序、更衣室、避免用手触摸办公室工作场所的门、把手等过程中传播和传播,并在现场的整个生产操作过程中传播。根据世界卫生组织的说法,这篇文章着眼于制药生产操作现场的各个阶段,必须根据产品类型和人员参与这些操作。预防感染的主要关键步骤是:•保持社交距离•使用口罩/面罩•经常用肥皂和水洗手或用含70%酒精的适当消毒液消毒。在生产现场隔离必要和非必要的员工。•非必要员工在家工作必要员工是那些被要求在生产现场亲自工作的员工制药行业正在通过修改相关SOP来非常自信地向前发展,以应对Covid - 19的影响和挑战。本文描述了Covid-19的“新常态-影响”以及个人卫生、保护工作场所和劳动力安全的出入境程序等基本要求。
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引用次数: 4
Consumer perception and experience regarding medicine packaging systems: A survey of medicine dispensing for outpatients 消费者对药品包装系统的感知和体验:门诊患者药品调剂的调查
C. Wiedyaningsih, F. Rahmawati, E. Lukitaningsih
Background Prescription unit packaging (PUP) and unit-of-dose packaging (UDP) are two types of medicine packaging systems utilized in hospital pharmacies across Indonesia. However, UDP is generally not used for outpatients. Objectives The purpose of this study was to investigate consumer perception and experience of the use of medicines in a packaging system for outpatients. Methods A cross-sectional descriptive study with quantitative and qualitative components was performed. A questionnaire about medicine distribution systems, involving packaging and usage was distributed from August to November 2018. During the same time frame, interviews were performed to identify participants’ experiences when using drugs that were distributed and packaged using the PUP system. Key findings: A total of 104 participants completed the questionnaire. Although 52.9% of the participants did not experience difficulties when using medicines distributed in PUP, 68.2% of participants preferred to use medicines in UDP. The reason for their choice of UDP was its practical use (80.8%), particularly if the medicine was taken when traveling (78.9%). Participants reported that UDP was very practical and helpful for geriatric patients, as UDP enables elderly people to use their medicine appropriately. Furthermore, they reported that UDP reminded consumers of the time to take their medicine. The problems with UDP were the number of packages and unfamiliarity. Conclusions Medicine was preferred in UDP by consumers but the model needs to be adapted to outpatients.
处方单位包装(PUP)和单位剂量包装(UDP)是印度尼西亚医院药房使用的两种药品包装系统。但是,UDP一般不用于门诊。目的本研究的目的是调查消费者的看法和经验,使用药品包装系统为门诊病人。方法采用定量和定性相结合的横断面描述性研究方法。2018年8月至11月分发了一份关于药品配送系统的问卷,涉及包装和使用。在同一时间框架内,进行了访谈,以确定参与者使用使用PUP系统分发和包装的药物时的经历。主要发现:共有104名参与者完成了问卷调查。虽然52.9%的参与者在使用PUP分发的药物时没有遇到困难,但68.2%的参与者更喜欢在UDP使用药物。他们选择UDP的原因是其实际用途(80.8%),特别是如果在旅行时服用药物(78.9%)。与会者报告说,UDP对老年患者非常实用和有帮助,因为UDP使老年人能够适当地使用他们的药物。此外,他们报告说,UDP提醒消费者吃药的时间。UDP的问题是包的数量和不熟悉。结论消费者在UDP中首选药物,但该模式需要适应门诊患者。
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引用次数: 1
Biogen v. Banner lifesciences: The federal circuit narrows the scope of PTE patents Biogen诉Banner生命科学案:联邦巡回法院缩小了PTE专利的范围
Paul A. Braier
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引用次数: 0
Voicing regulatory perspectives of the combination products 表达对组合产品的监管观点
Sumit Sanduria, Swagatika Tripathy, P. Murthy, BP Patra, H. Dureja
Combination products (CPs) are nothing but medical products that do not adequately apt solely into a regulatory category, but reasonably comprise of any combination of drug, device and biological product. The use of combination products and delivery systems are to deal with a chronic condition or to relieve an acute condition or to treat the various lives threaten & complex diseases. This article assesses the regulation of combination products in USA, India, China, Japan and Europe and likens the regulatory regime in pharmaceutical environments. Though many of these types of products have been available for years, recent FDA guidelines have spelled out viewpoint on both a development and commercialization perspective. These elucidations have led to augment regulatory expectations resulting in new and increased challenges. To make sure compliance with these regulations and beat challenges, it is essential to remain familiar with the dynamic changing regulations. This piece of writing spotlights on key aspects to understand the concept of combination products, its classification, review period and most importantly facts to consider when any organization is gearing up for a regulatory submission to regulatory agency and its prospective for PLCM of the combination product.
组合产品(CPs)只不过是医疗产品,不完全适合单独纳入监管类别,但合理地包括药物,器械和生物制品的任何组合。使用组合产品和给药系统是为了治疗慢性疾病或缓解急性疾病或治疗各种生命威胁和复杂疾病。本文评估了美国、印度、中国、日本和欧洲的联合产品监管,并比较了制药环境中的监管制度。虽然许多这类产品已经上市多年,但最近FDA的指导方针已经从开发和商业化的角度阐述了观点。这些阐明导致了监管期望的增加,从而带来了新的和增加的挑战。为了确保遵守这些法规并应对挑战,必须熟悉动态变化的法规。这篇文章聚焦于理解组合产品概念的关键方面,它的分类,审查期,以及当任何组织准备向监管机构提交监管申请时要考虑的最重要的事实,以及组合产品PLCM的前景。
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引用次数: 0
Analysis of new molecular entity trends from 2006 to 2015 in Japan 2006 - 2015年日本新分子实体趋势分析
Shoyo Shibata, Daigo Fukumoto, Koken Ozaki, Takeshi Suzuki
Japan is one of the largest pharmaceutical markets in the world, and as such, pharmaceutical companies are intensively conducting research and development of new drugs in Japan. However, information on Japanese pharmaceutical market profiles is limited. In this context, we elucidated the market characteristics and trends of new molecular entities approved between 2006 and 2015 in Japan. Among antineoplastic and immunomodulating agents, the highest number was first approved in the United States, and for nervous system drugs, the highest number was first approved in Europe. The alimentary tract and metabolism and the musculoskeletal system were the therapeutic areas for which the most drugs were approved for the first time in Japan. Most of the musculoskeletal system drugs were developed by Japanese companies, and most of the antineoplastic and immunomodulating agents were developed outside of Japan. Using various performance indexes, such as market forecasts and significance of clinical benefits, we determined that the number of new molecular entities and market size increased and the number of drugs with significant clinical benefits decreased. These results suggest that new molecular entity innovation by Japanese companies has been decreasing and the government’s comparative method for pricing does not work well in Japan.
日本是世界上最大的医药市场之一,因此,制药公司正在日本密集地进行新药的研究和开发。然而,关于日本制药市场概况的信息有限。在此背景下,我们阐明了2006年至2015年在日本批准的新分子实体的市场特征和趋势。在抗肿瘤和免疫调节剂中,数量最多的是在美国获得批准,而在神经系统药物中,数量最多的是在欧洲获得批准。消化道代谢和肌肉骨骼系统是日本首次获批药物最多的治疗领域。大多数肌肉骨骼系统药物是由日本公司开发的,大多数抗肿瘤和免疫调节剂是在日本以外开发的。利用市场预测、临床获益显著性等各项绩效指标,确定新分子实体数量和市场规模增加,临床获益显著的药物数量减少。这些结果表明,日本企业的新分子实体创新一直在减少,政府的比较定价方法在日本并不适用。
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引用次数: 0
Determinants of national drug products acceptance across patients, pharmacists, and manufacturers: A mixed method study 国家药品接受度在患者、药剂师和制造商之间的决定因素:一项混合方法研究
K. K. Ahmed, A. A. Al-Jumaili, Shihab Hattab Mutlak, Mohammed Kamel Hadi
Introduction The national pharmaceutical industry is pivotal for both the health sector and the national economy. This study aims to identify determinants of national drug products acceptance. The objectives of this study were to quantitatively measure the level of patient and community pharmacist acceptance of national drug products available in community pharmacies and to qualitatively explore the barriers facing national pharmaceutical companies and investigate the suggested solutions. Methods This cross-sectional study used an explanatory mixed method design. It was conducted in Baghdad, Iraq from July through October 2018. The study included two surveys (one for pharmacy customers and another for pharmacists) and thereafter semi-structured interviews of national pharmaceutical company owners/managers. The interview guide was developed based on preliminary quantitative results. Thematic analysis was used to analyze the interview findings. Results We received 123 patient surveys and 125 usable pharmacist surveys. We conducted seven interviews and stopped when we reached saturation. Integrated qualitative and quantitative findings showed that the main determinants of national drug product acceptance are product characteristics (namely price, packaging, brand, and availability), healthcare providers effect on product promotion and perceived effectiveness, and regulations enforced by authorities mainly the Ministry of Health. Conclusions Product price was the number one modulating factor in patient decision-making when purchasing a drug product. It appears that physicians and pharmacists are playing negative or at least neutral role in promoting national drug products and sustaining patients trust in national drug products. Current policies appeared to slow national drug industry growth and limit manufacturers’ ability to expand their share in the market. Manufacturer marketing efforts can help in gaining physicians and pharmacists support of the national drug product. Reforms to current drug policy and regulations were proposed by manufacturers.
国民医药工业是卫生部门和国民经济的支柱产业。本研究旨在确定国家药品接受度的决定因素。本研究的目的是定量测量患者和社区药剂师对社区药房提供的国家药品的接受程度,定性地探讨国家制药公司面临的障碍,并调查建议的解决方案。方法采用解释混合方法设计横断面研究。该调查于2018年7月至10月在伊拉克巴格达进行。该研究包括两项调查(一项针对药房顾客,另一项针对药剂师),然后是对全国制药公司所有者/经理的半结构化访谈。访谈指南是根据初步定量结果编制的。使用主题分析来分析访谈结果。结果共收到患者问卷123份,有效药师问卷125份。我们进行了七次采访,当我们达到饱和时就停止了。综合定性和定量研究结果表明,国家药品接受度的主要决定因素是产品特征(即价格、包装、品牌和可获得性)、医疗保健提供者对产品推广和感知有效性的影响,以及主要由卫生部执行的监管规定。结论药品价格是影响患者购买药品决策的首要因素。看来,医生和药剂师在促进国家药品和维持患者对国家药品的信任方面发挥了消极或至少中立的作用。目前的政策似乎减缓了国家药品工业的增长,限制了制造商扩大市场份额的能力。制造商的营销努力可以帮助获得医生和药剂师对国家药品的支持。对现行药品政策和法规的改革是由制造商提出的。
{"title":"Determinants of national drug products acceptance across patients, pharmacists, and manufacturers: A mixed method study","authors":"K. K. Ahmed, A. A. Al-Jumaili, Shihab Hattab Mutlak, Mohammed Kamel Hadi","doi":"10.1177/1741134320926625","DOIUrl":"https://doi.org/10.1177/1741134320926625","url":null,"abstract":"Introduction The national pharmaceutical industry is pivotal for both the health sector and the national economy. This study aims to identify determinants of national drug products acceptance. The objectives of this study were to quantitatively measure the level of patient and community pharmacist acceptance of national drug products available in community pharmacies and to qualitatively explore the barriers facing national pharmaceutical companies and investigate the suggested solutions. Methods This cross-sectional study used an explanatory mixed method design. It was conducted in Baghdad, Iraq from July through October 2018. The study included two surveys (one for pharmacy customers and another for pharmacists) and thereafter semi-structured interviews of national pharmaceutical company owners/managers. The interview guide was developed based on preliminary quantitative results. Thematic analysis was used to analyze the interview findings. Results We received 123 patient surveys and 125 usable pharmacist surveys. We conducted seven interviews and stopped when we reached saturation. Integrated qualitative and quantitative findings showed that the main determinants of national drug product acceptance are product characteristics (namely price, packaging, brand, and availability), healthcare providers effect on product promotion and perceived effectiveness, and regulations enforced by authorities mainly the Ministry of Health. Conclusions Product price was the number one modulating factor in patient decision-making when purchasing a drug product. It appears that physicians and pharmacists are playing negative or at least neutral role in promoting national drug products and sustaining patients trust in national drug products. Current policies appeared to slow national drug industry growth and limit manufacturers’ ability to expand their share in the market. Manufacturer marketing efforts can help in gaining physicians and pharmacists support of the national drug product. Reforms to current drug policy and regulations were proposed by manufacturers.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"1 1","pages":"139 - 153"},"PeriodicalIF":0.0,"publicationDate":"2020-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90620097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Assessment of the knowledge and perception of generic medications among pharmacy and medical students in the University of Sharjah, United Arab Emirates 评估阿拉伯联合酋长国沙迦大学药学和医科学生对非专利药品的知识和认知
S. Sharif, Souad Aldayeh, Huda Alsomali, F. Hayat
Background Generic substitution has become a common practice in several countries, primarily because of a major cost-minimizing strategy without compromising healthcare quality. Objective The study was carried out to assess the knowledge and perception of generic medication among final year pharmacy and medical students in the University of Sharjah. Method A cross-sectional survey was designed, pre-validated, and distributed during the period of September to November 2019 in the University of Sharjah, United Arab Emirates. The study research covered various aspects on knowledge and perception of generic medicines. It was distributed to 180 final year pharmacy and medicine students. Data were analyzed using SPSS, and Chi square test was used to determine the level of significance at p < 0.05. Result A total of 171 of 180 questionnaires were returned back including 87 and 84 surveys from pharmacy and medical students respectively producing a response rate of 95%. The majority of respondents in both collages were females, Arabs, and with parents of non-health care professions. Significantly more pharmacy than medical students agreed that cost-effective therapy and generics were covered in their study courses, generics are bioequivalent to brands and must contain the same amount of active ingredients like brands, that they are confident of their knowledge and more easily recall drugs by their generic names. Again more pharmacy students agreed that pharmacists should have the right to perform substitution but disagreed to the statement that generics takes longer time to produce therapeutic effects than brands. Conclusion Overall, Final-year students of pharmacy had better level of knowledge and perception of generic medicines and their right to perform generic substitution. Medical students seem to have limited knowledge of certain important aspects. Therefore, improvement of educational courses of future health-care professionals should be implemented early to enhance students’ awareness toward generic substitution.
在一些国家,非专利替代已成为一种普遍做法,主要是因为在不影响医疗质量的情况下实现成本最小化的主要策略。目的了解沙迦大学药学和医学专业毕业班学生对仿制药的知识和认知情况。方法于2019年9月至11月在阿联酋沙迦大学设计横断面调查,并进行预验证和分发。本研究涵盖了对仿制药的认识和认知的各个方面。它被分发给了180名药学和医学的大四学生。数据采用SPSS分析,采用卡方检验,p < 0.05为显著性水平。结果回收问卷180份,共171份,其中药学专业学生87份,医学生84份,回复率95%。在这两所大学中,大多数受访者都是女性、阿拉伯人,父母从事非保健职业。与医科学生相比,更多的药学学生认为,他们的学习课程涵盖了具有成本效益的疗法和仿制药,仿制药与品牌药具有生物等效性,必须含有与品牌药相同数量的活性成分,他们对自己的知识有信心,并且更容易通过仿制药名称召回药物。同样,更多的药学学生同意药剂师有权进行替代,但不同意仿制药比品牌药需要更长的时间才能产生治疗效果的说法。结论总体而言,药学专业高年级学生对仿制药的认知水平和认知水平以及实施仿制药替代的权利较高。医科学生在某些重要方面的知识似乎有限。因此,应及早实施对未来卫生保健专业人员的教育课程改进,提高学生对仿制药替代的认识。
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引用次数: 3
期刊
Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector
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