Stability analysis for drugs with multiple active ingredients.
For every drug product on the market, the United States Food and Drug Administration (FDA) requires that an expiration dating period (shelf-life) must be indicated on the immediate container label. For determination of the expiration dating period of a drug product, regulatory requirements and statistical methodology are provided in the FDA and ICH Guidelines. However, this guideline is developed for drug products with a single active ingredient. There are many drug products consisting of multiple active ingredients, especially for most traditional Chinese medicine. In this article, we propose a statistical method for determining the shelf-life of a drug product with multiple active ingredients following similar idea as suggested by the FDA and assuming that these active ingredients are linear combinations of some factors. Stability data observed from a traditional Chinese medicine were analysed to illustrate the proposed method.
Chow
Shein-Chung
SC
Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, NC 27705, USA. sheinchow@yahoo.com
Shao
Jun
J
D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000592:standards; D006801:Humans; D008956:Models, Chemical; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
D004365:Drugs, Chinese Herbal; D004364:Pharmaceutical Preparations