建议科学合理和适当的肠外用药抽样计划

EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES Pub Date : 2021-10-13 DOI:10.37521/ejpps.26303

Ian Aled Jones, Alex Bird, Nathaniel Lochrie

{"title":"建议科学合理和适当的肠外用药抽样计划","authors":"Ian Aled Jones, Alex Bird, Nathaniel Lochrie","doi":"10.37521/ejpps.26303","DOIUrl":null,"url":null,"abstract":"This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products\n\n\n Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture.\n\n\nKey Words: USP <1790>, visual inspection, AQL, power, sample size","PeriodicalId":300408,"journal":{"name":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","volume":"4 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2021-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products\",\"authors\":\"Ian Aled Jones, Alex Bird, Nathaniel Lochrie\",\"doi\":\"10.37521/ejpps.26303\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products\\n\\n\\n Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture.\\n\\n\\nKey Words: USP <1790>, visual inspection, AQL, power, sample size\",\"PeriodicalId\":300408,\"journal\":{\"name\":\"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES\",\"volume\":\"4 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-10-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.37521/ejpps.26303\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.37521/ejpps.26303","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

本文给出了定义抽样计划/大小的建议，这些建议在统计上是合理的，或基于典型非注射药物的已出版指南，基于ANSI/ASQ Z1.4验收抽样计划或其他已出版指南的简单表格已经整理，以帮助组织为常规药物生产选择适当的样本量/计划。关键词:USP，目测，AQL，功率，样本量

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products

This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture. Key Words: USP <1790>, visual inspection, AQL, power, sample size

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

EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES

自引率

0.00%

发文量