| Comment Record |
|
Commentor |
Dr. Ashraf Youssef |
Date/Time |
2002-03-12 18:22:46 |
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Organization |
TAP Pharmaceutical Products, Inc. |
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Category |
Individual |
| Comments for FDA General |
| Questions |
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1. General Comments
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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.
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