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hiren379 ★ India, 2012-05-02 10:39 (5153 d 00:54 ago) Posting: # 8486 Views: 5,036 |
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Hello friends, EMEA states below "Those HVDP for which a wider difference in Cmax is considered clinically irrelevant based on a sound clinical justification can be assessed with a widened acceptance range." Is it necessary to give the justification a priori in the protocol for no relevance of wider difference in Cmax.  |
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Dr_Dan ★★ Germany, 2012-05-02 11:28 (5153 d 00:05 ago) @ hiren379 Posting: # 8487 Views: 4,119 |
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Dear hiren379 IMHO you just have to point out in the protocol that the drug has no narrow therapeutic window and that a slightly higher variability of Cmax will not raise any safety concerns. This should be sufficient to allow the ethics committee to assess the study design and the planned evaluation of the results in order to give their approval. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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hiren379 ★ India, 2012-05-10 12:37 (5144 d 22:56 ago) @ Dr_Dan Posting: # 8551 Views: 4,000 |
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Thank you for your reply but should it be just stated or regulatory requires a strong back up justification (Clinical study) for the same. |
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akinapally ☆ 2012-05-10 15:22 (5144 d 20:10 ago) @ hiren379 Posting: # 8552 Views: 4,053 |
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Dear this below mentioned link may be give answer of your query http://www.eufeps.org/document/bonn09011415_presentations/Brown_David.pdf |
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mittyri ★★ Russia, 2015-02-03 14:16 (4145 d 20:17 ago) @ Dr_Dan Posting: # 14363 Views: 3,208 |
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Dear Dr.Dan & All, I apologize for leveling up so old thread, but I didn't find any additional topics. ❝ IMHO you just have to point out in the protocol that the drug has no narrow therapeutic window and that a slightly higher variability of Cmax will not raise any safety concerns. Can someone help with additional requirements or examples? PS: The link to the presentation above is broken  — Kind regards, Mittyri |
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