Shelf-life and its estimation in drug stability studies

doi:10.1080/02664763.2014.898135

CORC > 上海财经大学 > 上海财经大学

	Shelf-life and its estimation in drug stability studies
	Liu, W.1,2; Hsu, J. C.3; Bretz, F.4,5; Hayter, A. J.6; Han, Y.1,2
刊名	JOURNAL OF APPLIED STATISTICS
	2014-09
卷号	41 期号:9 页码:1989-2000
关键词	acceptance set confidence set lower confidence bound confidence level drug stability study shelf-life linear regression mixed-effects linear regression
ISSN号	0266-4763
DOI	10.1080/02664763.2014.898135
英文摘要	One important property of any drug product is its stability over time. Drug stability studies are routinely carried out in the pharmaceutical industry in order to measure the degradation of an active pharmaceutical ingredient of a drug product. One important study objective is to estimate the shelf-life of the drug; the estimated shelf-life is required by the US Food and Drug Administration to be printed on the package label of the drug. This involves a suitable definition of the true shelf-life and the construction of an appropriate estimate of the true shelf-life. In this paper, the true shelf-life T is defined as the time point at which 100% of all the individual dosage units (e.g. tablets) of the drug have the active ingredient content no less than the lowest acceptable limit L, where and L are prespecified constants. The value of T depends on the parameters of the assumed degradation model of the active ingredient content and so is unknown. A lower confidence bound T for T is then provided and used as the estimated shelf-life of the drug.
WOS研究方向	Mathematics
语种	英语
出版者	TAYLOR & FRANCIS LTD
WOS记录号	WOS:000336368300008
内容类型	期刊论文
源URL	[http://10.2.47.112/handle/2XS4QKH4/1712]
专题	上海财经大学
通讯作者	Liu, W.
作者单位	1.Univ Southampton, S3RI, Southampton, Hants, England; 2.Univ Southampton, Sch Maths, Southampton, Hants, England; 3.Ohio State Univ, Dept Stat, Columbus, OH 43210 USA; 4.Novartis Pharma AG, Basel, Switzerland; 5.Shanghai Univ Finance & Econ, Shanghai, Peoples R China; 6.Univ Denver, Dept Stat & Operat Technol, Denver, CO USA
推荐引用方式 GB/T 7714	Liu, W.,Hsu, J. C.,Bretz, F.,et al. Shelf-life and its estimation in drug stability studies[J]. JOURNAL OF APPLIED STATISTICS,2014,41(9):1989-2000.
APA	Liu, W.,Hsu, J. C.,Bretz, F.,Hayter, A. J.,&Han, Y..(2014).Shelf-life and its estimation in drug stability studies.JOURNAL OF APPLIED STATISTICS,41(9),1989-2000.
MLA	Liu, W.,et al."Shelf-life and its estimation in drug stability studies".JOURNAL OF APPLIED STATISTICS 41.9(2014):1989-2000.