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Activity Number:
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537
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #310299 |
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Title:
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Specifications Based on Pharmacokinetic Evaluation
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Author(s):
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Jose Casas-Finet*+ and Harry Yang and Iksung Cho and Mark Schenerman
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Companies:
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MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
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Address:
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One MedImmune Way, Gaithersburg, MD, 20878,
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Keywords:
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Specification ; PK
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Abstract:
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For a marketed drug product, the specifications are usually heavily reliant on manufacturing experience, since only a limited number of lots are used for clinical trials. This potentially could result in ranges narrower than what would have been allowed by clinical outcomes. In this paper, we propose a novel approach to evaluate the impact of the distribution of the attribute on the pharmacokinetic (PK) profile of the product lot. By modeling the theoretical relationship between the attribute and PK profile, we are able to identify a range of the attribute that produces bioequivalent drug product. The bioequivalent range, in conjunction with clinical safety data, can be used to justify specification limits that are typically wider than those derived solely from manufacturing history. The method is illustrated through a concrete example.
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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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