Abstract Details
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Activity Number:
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501
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Type:
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Contributed
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Date/Time:
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Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #311456
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View Presentation
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Title:
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Modeling Censored Stability Data Using Tobit Mixed Models
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Author(s):
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Seth Clark*+
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Companies:
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Merck
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Keywords:
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tobit ;
censored ;
regression ;
stability ;
quantitation limit ;
detection limit
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Abstract:
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It is not uncommon to encounter stability data that are censored due to results being below a quantitation limit of the assay. Often various crude methods are applied to the data, such as imputing values or modeling only the portion of the stability trend that is uncensored. An alternative method is proposed utilizing Tobit regression applied in the mixed model context to account for test-to-test variation. We show the approach allows one to model the distribution mean across the entire stability profile and reduces bias due to censored values.
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Authors who are presenting talks have a * after their name.
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