印度的固定剂量组合——这是一条多么好的路啊!

S. Chaudhry
{"title":"印度的固定剂量组合——这是一条多么好的路啊!","authors":"S. Chaudhry","doi":"10.18231/j.ijpp.2023.012","DOIUrl":null,"url":null,"abstract":"Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity having peak efficacy at different time zone, (c) Chemical non compatibility leading to decreased shelf life, (d) Drug interactions due to common metabolizing pathways, and (e) limitations of dose titration of individual ingredients. As per Rule 122 E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs where the Central Drugs Standard Control Organization (CDSCO), ensures proper clinical data is submitted for the approval into the market. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) mentions the requirements for marketing approval of various types of FDCs.","PeriodicalId":13313,"journal":{"name":"Indian Journal of Pharmacy and Pharmacology","volume":"70 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Fixed dose combinations in India- what a way to go!\",\"authors\":\"S. Chaudhry\",\"doi\":\"10.18231/j.ijpp.2023.012\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity having peak efficacy at different time zone, (c) Chemical non compatibility leading to decreased shelf life, (d) Drug interactions due to common metabolizing pathways, and (e) limitations of dose titration of individual ingredients. As per Rule 122 E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs where the Central Drugs Standard Control Organization (CDSCO), ensures proper clinical data is submitted for the approval into the market. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) mentions the requirements for marketing approval of various types of FDCs.\",\"PeriodicalId\":13313,\"journal\":{\"name\":\"Indian Journal of Pharmacy and Pharmacology\",\"volume\":\"70 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-03-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Pharmacy and Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18231/j.ijpp.2023.012\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Pharmacy and Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18231/j.ijpp.2023.012","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

在结核病、心血管疾病和糖尿病等慢性病、疟疾、艾滋病毒和癌症等热带病中,固定剂量组合通常被认为是理想的选择。FDC在慢性疾病中非常有用,特别是当多种疾病经常共存时。FDC的优点基本上是患者依从性,剂量表简单,疗效更好,运输和包装活动更便宜。fdc的缺点是(a)两种成分之间的药效学不匹配,一种药物具有加性/拮抗作用,导致疗效降低或副作用增强,(b)药代动力学差异,在不同时区产生峰值疗效,(c)化学不相容性导致保质期缩短,(d)由于共同代谢途径导致的药物相互作用,以及(e)单个成分剂量滴定的限制。根据1940年《药品和化妆品法》第122条E款,在中央药品标准控制组织(CDSCO)确保提交适当的临床数据以批准进入市场的情况下,fdc被视为新药。附表Y(药品和化妆品规则1945)的附录VI提到了各种类型的fdc的上市批准要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Fixed dose combinations in India- what a way to go!
Fixed dose combinations (FDCs) are generally considered desirable options in chronic diseases such as tuberculosis, cardiovascular diseases & diabetes, tropical diseases such as malaria & in HIV and in Cancer. FDCs are useful in chronic conditions especially when multiple disorders often co-exist The advantages of the FDC are basically patients compliance, simple dosage schedule, better efficacy, cheaper shipment & packaging activities. The drawbacks of FDCs are (a) Pharmacodynamic mismatch between the two ingredients, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced side effects, (b) Pharmacokinetic disparity having peak efficacy at different time zone, (c) Chemical non compatibility leading to decreased shelf life, (d) Drug interactions due to common metabolizing pathways, and (e) limitations of dose titration of individual ingredients. As per Rule 122 E of Drugs and Cosmetics Act 1940, the FDCs are considered as New Drugs where the Central Drugs Standard Control Organization (CDSCO), ensures proper clinical data is submitted for the approval into the market. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945) mentions the requirements for marketing approval of various types of FDCs.
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
自引率
0.00%
发文量
0
×
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
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