Docket Management
Docket: 00D-1630 - Final Guidance on Reproduction Toxicity Testing (VICH GL22)
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Ashraf Youssef Date/Time 2002-03-12 18:22:46
Organization TAP Pharmaceutical Products, Inc.
Category Individual

Comments for FDA General
1. General Comments line 148: and ano-genital distance.. Is it possible to include the preputial seperation also? I think using the measurments of both parameters (i.e., anogenital and preputial) may belong more to the reproductive maturity (functional toxicities) than to alteration to growth. Line 524: Indices of dose-response.. How would the presence of statistical significance vs. biological significance affect the evalution of the signal? Would the presence of a statistical significance increase the concern under any conditions. Would their be a road map or directives to help the reviewer to be able to make this judgment.

EC -1