안정성 연구에서의 사용기간에 관한 비모수적 추론
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김태규 | - |
dc.contributor.author | 박상규 | - |
dc.contributor.author | 하명호 | - |
dc.date.available | 2019-08-16T02:59:14Z | - |
dc.date.issued | 2010-03 | - |
dc.identifier.issn | 1229-1889 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/33756 | - |
dc.description.abstract | The shelf-life of pharmaceutical products is the time that the average product characteristic remains within an approved specification after manufacture. Since the true shelf-life of a drug product is typically unknown,it has to be estimated based on assay results of the drug characteristic from a stability study usually conducted during the process of drug development. The nonparametric statistical methods of assessing the shelf-life of drug are considered with the current FDA regulations. Some simulation studies of nonparametric methods are also presented with the discussion. | - |
dc.format.extent | 5 | - |
dc.language | 한국어 | - |
dc.language.iso | KOR | - |
dc.publisher | 한국품질경영학회 | - |
dc.title | 안정성 연구에서의 사용기간에 관한 비모수적 추론 | - |
dc.title.alternative | Nonprametric Inference of Shelf-life in Drug's Stability Study | - |
dc.type | Article | - |
dc.identifier.bibliographicCitation | 품질경영학회지, v.38, no.1, pp 96 - 100 | - |
dc.identifier.kciid | ART001431596 | - |
dc.description.isOpenAccess | N | - |
dc.citation.endPage | 100 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 96 | - |
dc.citation.title | 품질경영학회지 | - |
dc.citation.volume | 38 | - |
dc.publisher.location | 대한민국 | - |
dc.subject.keywordAuthor | Batch-to-batch variation | - |
dc.subject.keywordAuthor | Bootstrap | - |
dc.subject.keywordAuthor | Shelf-life | - |
dc.subject.keywordAuthor | Stability test | - |
dc.description.journalRegisteredClass | kci | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
84, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea (06974)02-820-6194
COPYRIGHT 2019 Chung-Ang University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.