Abstract #300075

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JSM 2002 Abstract #300075
Activity Number: 166
Type: Topic Contributed
Date/Time: Tuesday, August 13, 2002 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section*
Abstract - #300075
Title: Use of Generalized Linear Models for the Analysis of Viral Safety Data
Author(s): Paul McAllister*+
Affiliation(s): GlaxoSmithKline, Inc.
Address: , , , ,
Keywords:
Abstract:

Biotechnology related pharmaceutical processes have regulatory requirements to demonstrate viral clearance capability and to estimate stability of virus-containing manufacturing samples. Assays for viruses generally result in count data of the number of infected susceptible cells. Traditional methods of data analysis use naive and inconsistent methods of estimation. Analysis of both viral clearance and viral stability data are handled naturally with generalized linear models for Poisson distributed data. Use of a consistent modeling approach provides a distributionally correct framework for the relavant parameter estimates and their standard errors. The approach is illustrated in this talk with sample data and is shown to satisfy the latest ICH guidance on statistical evaluation of viral safety.

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