품질경영학회지 (Journal of Korean Society for Quality Management)

  • 제36권1호
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  • Pages.1-6
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  • 2008
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  • 1229-1889(pISSN)
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  • 2287-9005(eISSN)
한국품질경영학회 (Korean Society for Quality Management)
권호 표지

의약품 안정성 연구에서의 사용기간에 관한 통계적 추론

Statistical Inference of Shelf -life in Drug's Stability Study

  • 발행 : 2008.03.31
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초록

The purpose of stability study of pharmaceutical products is to establish the shelf life based on the change of the quality with time. Stability study generally consists of a random sample of dosage units from a batch or several batches placed in a storage room and periodically assayed for their drug content. The statistical methods of assessing the shelf-life of drug in the market is considered with the current KFDA regulations. An illustrated application to some stability data from the pharmaceutical industry is also presented with the discussion.

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참고문헌

  1. 의약품등의 안정성시험 기준 (2007). 식품의약품안정청고시 제 2007-14호
  2. Chow, S.C. and Shao, J. (1991). Estimating drug shelf-life with random batches. Biometrics 47, 1071-1079 https://doi.org/10.2307/2532659
  3. ICH Guidance for Industry (2003). Q1E Stability Data Evaluation
  4. SAS STAT User's Guide (1999). Chapter 41. The Mixed Procedure. Online Version 8
  5. Shao, J. and Chow, S.C. (1994). Statistical inference in stability analysis. Biometrics 50, 753-763 https://doi.org/10.2307/2532789
  6. Shao, J. and Chow, S.C. (2001). Drug shelf-life estimation. Statistica Sinica 11, 737-745