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의약품 안정성 연구에서의 사용기간에 관한 통계적 추론Statistical Inference of Shelf-life in Drug's Stability Study
- Issue Date
- Mar-2008
- Publisher
- 한국품질경영학회
- Keywords
- Batch-to-batch Variation; Fixed Eeffect; Random Effect; Shelf-life; Stability Test
- Citation
- 품질경영학회지, v.36, no.1, pp 1 - 6
- Pages
- 6
- Journal Title
- 품질경영학회지
- Volume
- 36
- Number
- 1
- Start Page
- 1
- End Page
- 6
- ISSN
- 1229-1889
- 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.
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