发布求助
文献互助 智能选刊 最新文献

IPRP对某些剂型的非专利药品放弃体内生物等效性研究的监管要求的调查

IF 0.3 Q4 PHARMACOLOGY & PHARMACY
GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2021-09-15 DOI:10.5639/gabij.2021.1003.019
A. Garcia Arieta, Clare Rodrigues
{"title":"IPRP对某些剂型的非专利药品放弃体内生物等效性研究的监管要求的调查","authors":"A. Garcia Arieta, Clare Rodrigues","doi":"10.5639/gabij.2021.1003.019","DOIUrl":null,"url":null,"abstract":"Medicines regulatory authorities aim to address rising healthcare costs and promote access to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"36 1","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms\",\"authors\":\"A. Garcia Arieta, Clare Rodrigues\",\"doi\":\"10.5639/gabij.2021.1003.019\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Medicines regulatory authorities aim to address rising healthcare costs and promote access to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product.\",\"PeriodicalId\":43994,\"journal\":{\"name\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"volume\":\"36 1\",\"pages\":\"\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2021-09-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GaBI Journal-Generics and Biosimilars Initiative Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5639/gabij.2021.1003.019\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"GaBI Journal-Generics and Biosimilars Initiative Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5639/gabij.2021.1003.019","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

药品监管机构的目标是通过审查和批准可与相应参考药品互换的高质量非专利药品，解决不断上升的医疗成本问题，并促进全世界药品的可及性。
本文章由计算机程序翻译，如有差异，请以英文原文为准。
分享
查看原文 本刊更多论文
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
Medicines regulatory authorities aim to address rising healthcare costs and promote access to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product.
求助全文
通过发布文献求助，成功后即可免费获取论文全文。 去求助
来源期刊
GaBI Journal-Generics and Biosimilars Initiative Journal
GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-
CiteScore
1.80
自引率
0.00%
发文量
0
期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整，为了账户安全，请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们：info@booksci.cn Book学术提供免费学术资源搜索服务，方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号：481959085
Book学术官方微信