This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 47
Type: Invited
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306044
Title: Similarity Criteria for Follow-On Biologics Based on an Approach
Author(s): Laszlo Endrenyi*+
Companies: University of Toronto
Address: , , ,
Keywords: Similarity for follow-on biologics ; Standardized contrasts ; Total variation ; Drug prescribabiltiy
Abstract:

The similarity of two biological entities must be based on different study conditions and differing procedures of evaluation than the determination of the BE of small molecules. For instance, interest centers on the similarity of drug disposition and not of absorption. The typical long half-lives necessitate parallel group, not of crossover studies. Total variation is relevant and not intraindividual variation. As a consequence, the prescribability of drugs, not switchability, is of concern. Nevertheless, an approach being applied for determining BE of highly-variable small molecules could be applied to the similarity of FoBs. Standardized contrasts of metrics have producer risks independent of the variability. They have useful clinical interpretations and yield acceptances which are much higher than without standardization. Their application to FoBs merits further explorations.


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