Table of Contents
Food and Drug Administration Center for Biologics Evaluation and Research Biological Response Modifiers Advisory Committee
Preclinical Considerations for Gene Transfer Clinical Trials: Vector Biodistribution
Biodistribution Studies Are...
Goals of Biodistribution Studies
Addressing These Goals
Results of the March 12, 1999 RAC Discussion on Gonadal Distribution
Results of the March 12, 1999 RAC Discussion on Gonadal Distribution
Sample Informed Consent Form
Sample Informed Consent Form (Cont’d)
When Can You “Postpone” Biodistribution Studies?
And When They May Not…
Sample Regulatory Letter for Studies Lacking Biodistribution Data
Sample Regulatory Letter (Cont’d)
Design Considerations for Vector Biodistribution Studies
Design Considerations for Vector Biodistribution Studies
Design Considerations for Vector Biodistribution Studies
Design Considerations for Vector Biodistribution Studies
Design Considerations for Vector Biodistribution Studies
In Summary….
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