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drchilkoti ☆ India, 2013-05-24 05:27 (4785 d 07:52 ago) Posting: # 10636 Views: 3,384 |
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Can we do BE study of Valganociclovir on Healthy adults? I have found no supporting document other than FDA draft recommendation for Valganciclovir. Please also note for Ganciclovir (Valganciclovir is prodrug of ganciclovir) FDA recommends BE study on patients. Thanks, Deepak |
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jag009 ★★★ NJ, 2013-05-24 19:00 (4784 d 18:19 ago) @ drchilkoti Posting: # 10645 Views: 2,885 |
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Hi, Have you found out the reason why patient population is required? With FDA (ANDA) you are pretty much stuck with their recommendation unless you can come up with justifications (ie: back up with safety-exposure data). John |
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govardhanpillari ☆ India, 2013-05-26 13:49 (4782 d 23:29 ago) @ drchilkoti Posting: # 10659 Views: 2,942 |
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❝ Can we do BE study of Valganociclovir on Healthy adults? I have found no supporting document other than FDA draft recommendation for Valganciclovir. May I know for which regulatory you are targeting? This can be conducted in healthy volunteers... it is safe and well tolerated in healthy volunteers... — Govardhan.P |
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