Abstract:
:The potency of a batch of drug product needs to meet a release limits at the time of release so that the potency at the end of shelf life remains above the lower registration limit (LRL). This article discusses two methods which determine the release limits such that the chance to fail LRL at the end of shelf life of the product will be controlled under a desirable level. In additional to controlling failure rate, a method which determines the release limits such that the expected total cost due to rejecting a batch at time zero and at the end of shelf life is minimized. All the methods assume a very flexible sampling schedule, and are simple to implement. Each method is illustrated in an example.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Wei GCdoi
10.1080/10543409808835225subject
Has Abstractpub_date
1998-03-01 00:00:00pages
103-14issue
1eissn
1054-3406issn
1520-5711journal_volume
8pub_type
杂志文章abstract::Drug-related side effects are one of the leading causes of death and illness in the developed world. Finding genes that modify drug response has the potential to significantly improve drug delivery, by identifying both individuals that can benefit from therapy and those at increased risk of harm. We present a simple a...
journal_title:Journal of biopharmaceutical statistics
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pub_type: 杂志文章,评审
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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journal_title:Journal of biopharmaceutical statistics
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