Journal of Korean Society for Quality Management (품질경영학회지)

Korean Society for Quality Management (한국품질경영학회)
권호 표지

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

의약품 안정성 연구에서의 사용기간에 관한 통계적 추론

  • Published : 2008.03.31
Download PDF
⟨ Previous Next ⟩

Abstract

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.

Keywords

References

  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