의약품 안정성 연구에서의 사용기간에 관한 통계적 추론
Statistical Inference of Shelf-life in Drug's Stability Study
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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.
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.
참고문헌 (6)
- "의약품등의 안정성시험 기준", 식품의약품안정청고시 제 2007-14호, ~ (2007)
- Chow, S.C., "Estimating drug shelf-life with random batches", Biometrics, 47, pp.1071~1079 (1991)
- ICH Guidance for Industry, "Q1E Stability Data Evaluation" (2003), ICH Guidance for Industry
- "SAS STAT User's Guide : Chapter 41. The Mixed Procedure. Online Version 8.", ~ (1999)
- Shao, J., "Statistical inference in stability analysis", Biometrics, 50, pp.753~763 (1994)
- Shao, J., "Drug shelf-life estimation", Statistica Sinica, 11, pp.737~745 (2001)