FDA Perspectives on the Use of the Adenovirus Reference Material

by Stephanie Simek, PhD, Andrew Byrnes, PhD, and Steven Bauer, PhD
Volume 1, Issue 3 (Fall 2002)

As development proceeds for adenoviral vectors in gene transfer clinical trials, it becomes increasingly important that these products demonstrate a good safety profile, and thereby build confidence in those who must make decisions about risk/benefit ratios, dose escalation, and efficacy. Currently, safety and efficacy are based predominantly upon the analysis of data generated by non-standardized methods, resulting in inconsistent values being reported for virus titer and particle counts...

Citation:
Simek S, Byrnes A, Bauer S. FDA Perspectives on the Use of the Adenovirus Reference Material. BioProcess J, 2002; 1(3): 40-42.