This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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17
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307028 |
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Title:
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An Industry Perspective on Shelf Life and the PQRI Initiative
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Author(s):
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Pat Forenzo*+
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Companies:
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Novartis Pharmaceuticals Corporation
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Address:
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PHAD ARD, East Hanover, NJ, 07936-1080,
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Keywords:
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shelf life ;
ICH ;
PQRI
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Abstract:
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For pharmaceutical products, shelf life is the period of time during which a product, if stored correctly, is expected to comply with specifications as determined by stability studies. Regulatory guidance is provided in the ICH Q1A (R2) and Q1E documents which help to define current practices in the estimation of the shelf life of a pharmaceutical product. The Product Quality Research Institute Stability Shelf Life Working Group (PQRI SSL WG) was established in 2006 to provide a review of the philosophy, intent and statistical methods for estimating shelf life. This session provides an overview that effort, presented by members of the Working Group.
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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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