Food and Drug Administration Center for Biologics Evaluation and Research Biological Response Modifiers Advisory Committee

12/5/00


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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….

PPT Slide

Author: CBER