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msmnainar ★ India, 2015-04-27 11:09 (3721 d 13:44 ago) Posting: # 14739 Views: 9,935 |
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Dear all According to ANVISA's resolution - RE n. 898, of May 29, 2003, For highly variable drug products, replicated crossover design shall be adopted following Bataam design or Williams design. However, anybody could clarify whether these two methods allow widening of confidence interval for PK parameters based on the observed intra-individual variability of the reference product. Otherwise, Kindly advice whether ANVISA would allow SABE design based on USFDA or EMEA methods for highly variable drug products. Thanks — Sundar. M |
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nobody nothing 2015-04-27 11:15 (3721 d 13:38 ago) @ msmnainar Posting: # 14740 Views: 8,486 |
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Hi! For the start (search function of the forum  )http://forum.bebac.at/forum_entry.php?id=7011 http://forum.bebac.at/forum_entry.php?id=9536 ...maybe someone has more recent infos Enjoy! Οὐδείς — Kindest regards, nobody |
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Samaya B ☆ India, 2015-04-27 12:03 (3721 d 12:50 ago) @ msmnainar Posting: # 14741 Views: 8,418 |
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Dear Sundar, ANVISA accepts SABE design for highly variable drug products. We have recently submitted a protocol for a HVDP using full repliacted design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV. Widening criteria for confidence interval remained same as that of EU guidance. Hope this would be helpful. Thanks. Regards, Samaya. |
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luvblooms ★★ India, 2015-04-27 13:34 (3721 d 11:19 ago) @ Samaya B Posting: # 14742 Views: 8,425 |
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Dear Samaya ❝ ANVISA accepts SABE design for highly variable drug products. Not always. There have been cases where full study data along with the published information of higher variability >30% has been shared with ANVISA and they straight forward rejected it saying that they have sufficient information/study data with them which suggest that the product passed is not highly variable and asked us to do the same. ❝ We have recently submitted a protocol for a HVDP using full replicated design for ANVISA review. Along with a protocol, you can submit literature references showing >30% ISCV. You just got lucky!!!! That's all I will say as per my interaction with ANVISA. They are tough nut to crack!! ❝ Widening criteria for confidence interval remained same as that of EU guidance. Does this mean that widening given only for Cmax and max limit will be 69-143? Any specific reason behind it? — ~A happy Soul~ |
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Samaya B ☆ India, 2015-04-27 14:03 (3721 d 10:50 ago) @ luvblooms Posting: # 14743 Views: 8,382 |
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Hi Luvblooms ❝ You just got lucky!!!! That's all I will say as per my interaction with ANVISA. They are tough nut to crack!! True.. that is the reason I have mentioned to submit a protocol with replicated design for ANVISA review before initiating a study. ❝ Does this mean that widening given only for Cmax and max limit will be 69-143? During ANVISA review, the agency had asked us to follow EU guidance for widening. (so I assume widening would be applicable to Cmax only). ❝ Any specific reason behind it? Not sure! Regards, Samaya |
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felipeberlinski ☆ Brazil, 2015-04-27 17:36 (3721 d 07:18 ago) @ Samaya B Posting: # 14744 Views: 8,287 |
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Hi Samaya It is very interesting to know that ANVISA is accepting somehow SABE!  Have you just submitted the protocol or you have also scheduled a meeting with them? They have issued an official responde, minutes...? Your argue was just on CV% or did you have to prove within a pilot? Thanks Regards |
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msmnainar ★ India, 2015-04-28 15:11 (3720 d 09:42 ago) @ felipeberlinski Posting: # 14745 Views: 8,196 |
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Dear all Thank you for your information. Regards, — Sundar. M |
Ing. Helmut Schütz