Where Drug Shelf Life is Valid but Performance Life Crosses
نویسندگان
چکیده
منابع مشابه
Drug Shelf-life Estimation
The shelf-life of a drug product is the time that the average drug characteristic (e.g., potency) remains within an approved specification after manufacture. The United States Food and Drug Administration (FDA) requires indication for every drug product of a shelf-life on the immediate container label. Since the true shelf-life of a drug product is typically unknown, it has to be estimated base...
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In the pharmaceutical industry, a stability study is usually conducted to establish the drug expiration dating period(or shelf-life) of a drug product. The method suggested in the current FDA guidelines does not consider the situation when there is a batch-to-batch variation. Chow and Shao (1991) proposed a model which can take into account the batch-to-batch variation results. In this paper, a...
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The aim of this project was to investigate and develop models for the shelf life of bottled wine and, in particular, the effects of elevated temperatures on the aging process. The MISG group divided the problem into three sub-problems. First, calculations were made to describe the temperature of wine in a single bottle when subjected to an elevated external temperature and then this was extende...
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ژورنال
عنوان ژورنال: INTERNATIONAL JOURNAL OF ENDORSING HEALTH SCIENCE RESEARCH (IJEHSR)
سال: 2020
ISSN: 2307-3748,2310-3841
DOI: 10.29052/ijehsr.v8.i1.2020.01-03