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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393
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306974 |
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Title:
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Considerations in the Development of Biologics and Biosimilars: A Case Study
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Author(s):
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Amy Ko*+
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Companies:
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Merck & Co., Inc.
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Address:
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RY34-A316, Rahway, NJ, 07065,
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Keywords:
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Biologics ;
Biosimilars
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Abstract:
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While increasing number of pharmaceutical companies are joining the rank of developing biologics and biosimilars, guidances for many aspects of the development process are either not defined yet or being revised by the regulatory agencies. This leaves a considerable level of uncertainty that the companies have to content with. This presentation will touch on some of the regulatory and development considerations in the fields of biologics and biosimilars.
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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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