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jansari ☆ India, 2023-02-21 18:28 (601 d 13:40 ago) Posting: # 23469 Views: 3,380 |
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Dear All, Is there any specific guidance documents for in vitro binding study for sevelamer carbonate for EU submission? Is there any acceptance limit for Sevelamer carbonate product for EMA submission? A response will be highly appreciated. Thanks in advance for your help. Regards, Jansari |
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dshah ★★ India, 2023-02-22 17:40 (600 d 14:28 ago) @ jansari Posting: # 23470 Views: 2,767 |
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Dear Jansari! Kindly refer your own post Sevelamer Carbonate In vitro binding study for EMA submission (Post#22597). Kindly refer Renvela CHMP ASSESSMENT REPORT ![[image]](img/uploaded/image192.jpg) Regards, Divyen |
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jansari ☆ India, 2023-02-23 17:22 (599 d 14:46 ago) @ dshah Posting: # 23472 Views: 2,717 |
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Dear Divyen, Thank you very much for your kind support..but still I want some clarity. ❝ Kindly refer your own post Sevelamer Carbonate In vitro binding study for EMA submission (Post#22597). yes it's my Post..but still not getting any clearity about this...all PAR and guidance documents are available as per USFDA guidance..as Europe guidance is different for sevelamer carbonate..and they didn't accept USFDA guidance documents.. regulatory didn't accept our study which we were performed based on USFDA guidance ..so we have to perform the same study again as per Europe guidance ..so before starting the study i want to clear about the acceptance limit. ❝ Kindly refer Renvela CHMP ASSESSMENT REPORT they given the reference of following of guidance documents of Europe:: Guideline for locally applied , locally acting product in Gestrointestinal trac(CPMP/EWP/239/95Rev.1,Cor.1*) and this guidance documents given the acceptance limit as +- 10percentage.. The CHMP assessment which you have shared is also published in the year 2009.. Thanks in advance.... Regards, jansari... Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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dshah ★★ India, 2023-02-23 18:18 (599 d 13:50 ago) (edited on 2023-02-23 19:32) @ jansari Posting: # 23473 Views: 2,701 |
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Dear Jansari! ❝ ❝ yes it's my Post..but still not getting any clearity about this...all PAR and guidance documents are available as per USFDA guidance..as Europe guidance is different for sevelamer carbonate..and they didn't accept USFDA guidance documents.. regulatory didn't accept our study which we were performed based on USFDA guidance ..so we have to perform the same study again as per Europe guidance ..so before starting the study i want to clear about the acceptance limit. ❝ ❝ they given the reference of following of guidance documents of Europe:: Guideline for locally applied , locally acting product in Gestrointestinal trac(CPMP/EWP/239/95Rev.1,Cor.1*) and this guidance documents given the acceptance limit as +- 10percentage.. Read the sentence again: In vitro similarity should be assessed with a ±10% acceptance range, unless otherwise justified. Kindly refer Calcium acetate USFDA PSG. ![[image]](img/uploaded/image196.jpg) Regards, Divyen |
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jansari ☆ India, 2023-02-24 16:24 (598 d 15:44 ago) @ dshah Posting: # 23474 Views: 2,663 |
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Dear Divyen ❝ ❝ ❝ they given the reference of following of guidance documents of Europe:: Guideline for locally applied , locally acting product in Gestrointestinal trac(CPMP/EWP/239/95Rev.1,Cor.1*) and this guidance documents given the acceptance limit as +- 10percentage.. ❝ ❝ Read the sentence again: In vitro similarity should be assessed with a ±10% acceptance range, unless otherwise justified. we were already given justification based on this sentence.and explain that our study is passing within T/R ratio as per acceptance limit 0.9 to 1.1...but they are not accepting the same and again raised the queries....so now we are repeating the same study ,. can I have your mail ID ?so I can detailed out the study detail which results we obtained in the study..and what exactly regulatory asked? ❝ Kindly refer Calcium acetate USFDA PSG. ❝ Awaiting for your positive reply..:- Regards, jansari Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
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dshah ★★ India, 2023-02-28 18:15 (594 d 13:53 ago) @ jansari Posting: # 23481 Views: 2,512 |
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Dear Jansari! ❝ we were already given justification based on this sentence.and explain that our study is passing within T/R ratio as per acceptance limit 0.9 to 1.1...but they are not accepting the same and again raised the queries....so now we are repeating the same study ,. So you are aware about the acceptance limit. Currently what I am able to understand is that you are referring term regulatory for your company's regulatory team and not the authority's team. If it's authority's team- you are already having your answers. ❝ can I have your mail ID ?so I can detailed out the study detail which results we obtained in the study..and what exactly regulatory asked? You can contact me via contact form in users section but your mail is is not registered, so i am not able to contact you through same medium. ![[image]](img/uploaded/image197.jpg) Regards, Divyen |
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jansari ☆ India, 2023-03-01 16:34 (593 d 15:34 ago) (edited on 2023-03-02 16:16) @ dshah Posting: # 23482 Views: 2,443 |
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Dear Divyen, Now I am registered my mail ID in user section.. So we can further communicate with this mail id...also I am doing mail for confirmation... Thank you once again and awaiting for your reply... Regards, jansari.... Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Please use the in the future. BTW, never, ever post your e-mail address on any public forum! I activated the PM in your profile. [Helmut] |
Ing. Helmut Schütz