The Estimation of Drug Shelf-life
نویسنده
چکیده
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 is developed based upon in assay SAS procedure the method proposed by Shao and Chow (1992) to determine the labeled shelf-life of a drug product. An example concerning a pre-approval stability analysis for estimation of drug shelf-life is discussed. In the each drug
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