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Journal of generic medicines最新文献

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Generic drug labeling: Recent developments since Pliva, Inc. v. Mensing 仿制药标签:自Pliva, Inc.诉Mensing以来的最新发展
Journal of generic medicines Pub Date : 2023-07-28 DOI: 10.1177/17411343231191647
Hannah Lief
{"title":"Generic drug labeling: Recent developments since Pliva, Inc. v. Mensing","authors":"Hannah Lief","doi":"10.1177/17411343231191647","DOIUrl":"https://doi.org/10.1177/17411343231191647","url":null,"abstract":"The Hatch-Waxman Amendments to the Food, Drug, & Cosmetic Act requires generic drug manufacturers to match their labeling to the bioequivalent brand-name drug. The decision in PLIVA, Inc. v. Mensing reinforced the liability implications when there is a lack of safety information on brand-name drugs by holding the brand-name drug manufacturer liable for failing to fully inform consumers of the relevant safety risks associated with a particular drug. Following this decision, the Consolidated Appropriations Act of 2021 introduced a new process for generic drug manufacturers to update their safety information independent of its bioequivalent brand-name drug.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"67 1","pages":"145 - 148"},"PeriodicalIF":0.0,"publicationDate":"2023-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84067337","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: 0
An overview of over-the-counter monograph system in US 美国非处方专著制度概述
Journal of generic medicines Pub Date : 2023-06-26 DOI: 10.1177/17411343231170783
Riya P Thakre, Anil S Khokale, K. Salunkhe
{"title":"An overview of over-the-counter monograph system in US","authors":"Riya P Thakre, Anil S Khokale, K. Salunkhe","doi":"10.1177/17411343231170783","DOIUrl":"https://doi.org/10.1177/17411343231170783","url":null,"abstract":"The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the-counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. Non-prescription drugs may be marketed legally in the US through the drug application process and the Over-the-Counter Drug Review (OTC drug monograph) procedure. The criteria and procedures cover how OTC medications that were initially marketed in the United States following the start of the OTC drug review in 1972, as well as OTC medications without any prior U.S. marketing experience, can satisfy the legal definition of marketing to a “material extent” and “for a material time” and qualify. In accordance with FDA’s OTC drug monograph standards, if the condition is deemed qualifying, it would be assessed for general recognition of safety and effectiveness. The FDA is also making changes to the OTC medicine monograph processes in order to speed up the processing and add more details to the evaluation. Therefore, this article emphasizes the OTC monograph system and its procedure.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"11 1","pages":"141 - 144"},"PeriodicalIF":0.0,"publicationDate":"2023-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78285428","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: 0
EU legal and regulatory update APRIL 2023 欧盟法律法规更新2023年4月
Journal of generic medicines Pub Date : 2023-06-01 DOI: 10.1177/17411343231172777
R. Milchior
{"title":"EU legal and regulatory update APRIL 2023","authors":"R. Milchior","doi":"10.1177/17411343231172777","DOIUrl":"https://doi.org/10.1177/17411343231172777","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"28 1","pages":"105 - 113"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88008987","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: 0
The journal of generic medicines – Editorial June 2023 仿制药杂志- 2023年6月社论
Journal of generic medicines Pub Date : 2023-05-09 DOI: 10.1177/17411343231176319
B. Tempest
{"title":"The journal of generic medicines – Editorial June 2023","authors":"B. Tempest","doi":"10.1177/17411343231176319","DOIUrl":"https://doi.org/10.1177/17411343231176319","url":null,"abstract":"","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"10 1","pages":"65 - 65"},"PeriodicalIF":0.0,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80844118","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: 0
Precision medicine patent prosecution at the USPTO: What can be expected? 美国专利商标局的精准医疗专利审查:可以期待什么?
Journal of generic medicines Pub Date : 2023-04-28 DOI: 10.1177/17411343231172347
Benjamin S. Prebyl
{"title":"Precision medicine patent prosecution at the USPTO: What can be expected?","authors":"Benjamin S. Prebyl","doi":"10.1177/17411343231172347","DOIUrl":"https://doi.org/10.1177/17411343231172347","url":null,"abstract":"This paper examines some of the intricacies and challenges relating to Restriction Practice and Subject Matter Eligibility that can be encountered while on the road to obtaining U.S. patent protection for precision medicine inventions. Because of the complex and often inconsistent application of the relevant patent law to precision medicine inventions, IP counsel should be consulted on how to best protect these discoveries.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"3 1","pages":"101 - 104"},"PeriodicalIF":0.0,"publicationDate":"2023-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78506265","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: 0
Generic drug application and approval process in Vietnam and Philippines 越南和菲律宾的仿制药申请和批准程序
Journal of generic medicines Pub Date : 2023-03-14 DOI: 10.1177/17411343231162763
Sayali C Kankariya, A. Mundada
{"title":"Generic drug application and approval process in Vietnam and Philippines","authors":"Sayali C Kankariya, A. Mundada","doi":"10.1177/17411343231162763","DOIUrl":"https://doi.org/10.1177/17411343231162763","url":null,"abstract":"A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use, but does not carry the brand name. Generic medicines are those where the original patent has expired and which may now be produced by manufacturers other than the original innovator company. A generic drug must contain the same active ingredients as the original brand-name formulation. The present review article describes the generic drug registration and approval process for two ASEAN countries Vietnam and Philippines.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"38 1","pages":"120 - 123"},"PeriodicalIF":0.0,"publicationDate":"2023-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72721154","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: 0
Assessment of the differences between generic and biosimilar drugs: A brief literature review 评估仿制药和生物仿制药之间的差异:简要的文献综述
Journal of generic medicines Pub Date : 2023-02-17 DOI: 10.1177/17411343231157309
Roudy Sayah, S. Awada, Lina Ismaiil, Georges Hatem
{"title":"Assessment of the differences between generic and biosimilar drugs: A brief literature review","authors":"Roudy Sayah, S. Awada, Lina Ismaiil, Georges Hatem","doi":"10.1177/17411343231157309","DOIUrl":"https://doi.org/10.1177/17411343231157309","url":null,"abstract":"Generic Drugs are copies of small chemical drugs identical to their reference drug by dose, form, safety, strength, mode of administration, quality, performance, and intended purpose. They have been on the market for a long time and have abbreviated pathways to be approved. Their development is more simple and more affordable than their reference counterpart, which makes them widely used by patients. More recently, biosimilars were introduced to the market with strict regulations. They are highly similar to large, complex molecules, known as biological drugs, in terms of quality characteristics, biological activity, safety, and efficacy. Their development is complex and expensive, where clinical trials are necessary. Even though generic drugs and biosimilars are both copies of a reference drug, they differ in many aspects. Misconceptions or misinformation among healthcare stakeholders could have limited their use. Therefore, this short review aims to compare generic drugs and biosimilars in terms of characteristics, development, regulation, and interchangeability with brand drugs. Findings from this report can help clarify misconceptions and promote their use.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"1 1","pages":"124 - 129"},"PeriodicalIF":0.0,"publicationDate":"2023-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90753169","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
An empirical study to accelerate machine learning and artificial intelligence adoption in pharmaceutical manufacturing organizations 加速机器学习和人工智能在制药企业应用的实证研究
Journal of generic medicines Pub Date : 2023-01-10 DOI: 10.1177/17411343221151109
A. Pazhayattil, Gyongyi Konyu-Fogel
{"title":"An empirical study to accelerate machine learning and artificial intelligence adoption in pharmaceutical manufacturing organizations","authors":"A. Pazhayattil, Gyongyi Konyu-Fogel","doi":"10.1177/17411343221151109","DOIUrl":"https://doi.org/10.1177/17411343221151109","url":null,"abstract":"The quantitative study investigated factors that influence the initiation, the convergence prospects, the highest return on investment sector, and the variables that can delay machine learning and artificial intelligence in the pharmaceutical industry. The study population constituted individuals from the US FDA pharmaceutical sites registry, representing all sectors of the industry. The study reports the trends and preferences identified by the industry executives who participated in the survey. The first hypothesis utilized Kruskal Walli confirming a statistically significant difference in the applicability of Rogers’s diffusion of innovation theory in the pharmaceutical industry. The second hypothesis test utilized Kendall’s τ identified that machine learning and artificial intelligence convergence is imminent. Spearman’s rank-order correlation test was used for the third hypothesis, providing insights into the high return-on-investment areas, namely, operations efficiency, product quality, supply chain integrity, market identification, and penetration, and engineering and maintenance sectors of the industry. The fourth hypothesis applied Spearman’s rank-order correlation test that confirmed that the five artificial intelligence (AI) implementation delay factors, namely, lack of strategy, finding talent, functional silos, management commitment, and behavioral change using the output can cause delays in machine learning and AI projects in the pharmaceutical industry.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"15 1","pages":"81 - 91"},"PeriodicalIF":0.0,"publicationDate":"2023-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90828436","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: 1
Abbreviated new drug submission approval process: An overview 简略的新药申报审批流程:概述
Journal of generic medicines Pub Date : 2022-12-24 DOI: 10.1177/17411343221146094
Sonali S Amrutkar, S. B. Patil, A. Mundada
{"title":"Abbreviated new drug submission approval process: An overview","authors":"Sonali S Amrutkar, S. B. Patil, A. Mundada","doi":"10.1177/17411343221146094","DOIUrl":"https://doi.org/10.1177/17411343221146094","url":null,"abstract":"A generic drug is a copy of a brand name drug which can be introduced into the market once innovators patent expires. More than 73% of prescription drugs sold at retail in Canada are generics and thus Canada represents the world’s 9th biggest market for generic drugs in terms of value. Canada’s generic pharmaceutical sector produces domestically less than 10% of the active pharmaceutical ingredients used in its medicines. It also imports 88% of the finished dose products. Drug manufacturer has to demonstrate that its product is pharmacologically effective and bioequivalent to the innovator’s drug. The generic drug is bioequivalent or pharmaceutically equivalent to the Canadian Reference Product (CRP). The Abbreviated New Drug submission (ANDS) regulations were created to make the generic drug approval process simpler and more cost-effective by health drug Canada.","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"16 1","pages":"75 - 80"},"PeriodicalIF":0.0,"publicationDate":"2022-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78941139","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: 0
In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of Dessie town, Northeast Ethiopia 埃塞俄比亚东北部Dessie镇社区药店通用环丙沙星片体外质量评价
Journal of generic medicines Pub Date : 2020-05-06 DOI: 10.1177/1741134320921929
H. K. Desta, T. T. Teklehaimanot
{"title":"In vitro quality evaluation of generic ciprofloxacin tablets available in community pharmacies of Dessie town, Northeast Ethiopia","authors":"H. K. Desta, T. T. Teklehaimanot","doi":"10.1177/1741134320921929","DOIUrl":"https://doi.org/10.1177/1741134320921929","url":null,"abstract":"The introduction of generic drug products from multiple sources into the health care system of many developing countries may lead to spread of substandard medicines. Post marketing surveillance is ...","PeriodicalId":91117,"journal":{"name":"Journal of generic medicines","volume":"63 1","pages":"174113432092192"},"PeriodicalIF":0.0,"publicationDate":"2020-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88368917","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
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