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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305088 |
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Title:
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Using STATLIA for Bioassay Evaluation in Regulatory Environment
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Author(s):
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Lev Sirota*+ and Boris G. Zaslavsky
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Companies:
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FDA and FDA
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Address:
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1401 Rockville Pike HFM-217 , Rockville, MD, 20852,
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Keywords:
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bioassay ; software
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Abstract:
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Bioassay is an experiment for estimating the potency of a drug material or biologic. It uses the reaction that follows its application to living matters. Indirect assays are based on comparison of dose-response dependencies of test substance and standard preparation. Similarity of shape of test and reference profiles, aka parallelism, is of critical importance in this type of assay. Different definitions of parallelism have been proposed. Their usefulness may be evaluated by their efficiency and appeal to practitioners. In this presentation we discuss the efficiency of the metric of parallelism implemented in STATLIA software.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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