안정성 연구에서의 사용기간에 관한 비모수적 추론
Nonprametric Inference of Shelf-life in Drug's Stability Study
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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.
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.
참고문헌 (5)
- 김태규, "의약품 안정성 연구에서의 사용기간에 관한 통계적 추론", 품질경영학회지, 36(1), pp.1~6 (2008), 한국품질경영학회
- "의약품등의 안정성시험 기준", 식품의약품안정청고시 제 2007-14호, ~ (2007)
- ICH Guidance for Industry, "Q1E Stability Data Evaluation", ~ (2003)
- Davidson,A.C, "Bootstrap methods and their application" (1997), Cambridge University Press
- Theil,H, "A rank-invariant method of linear and polynomial regression analysis", Indigatuines Mathematicae, 12, pp.85~91 (1950)