jansari
☆    

India,
2021-09-24 19:03
(368 d 14:09 ago)

(edited by jansari on 2021-09-24 19:57)
Posting: # 22597
Views: 1,172
 

 Sevelamer Carbonate In vitro binding study for EMA submission [Regulatives / Guidelines]

Dear All,

As I am working in In vitro laboratory. And we are doing In-vitro binding study on Sevelamer carbonate sachets for EMA submission.


My question is, whether EMA will accepts the In-vitro phosphate binding studies for generic submission like US. Is there any specific guidance documents for statistical analysis of Sevelamer carbonate for EMA Submission or can we perform statistical analysis as per USFDA guidance documents?

And if we perform statistical analysis as per USFDA guidance documents(Acceptance limit for K2-80% to 120%) is it acceptable 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,
APJ
jansari
☆    

India,
2022-05-19 20:02
(131 d 13:10 ago)

@ jansari
Posting: # 23004
Views: 456
 

 Sevelamer Carbonate In vitro binding study for EMA submission

Please help me to shortout the query on priority

Your valuable response is highly appreciable....


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]
dshah
★★  

India/United Kingdom,
2022-05-26 13:28
(124 d 19:44 ago)

@ jansari
Posting: # 23022
Views: 495
 

 Sevelamer Carbonate In vitro binding study for EMA submission

Dear Jansari!

In-vitro phosphate binding studies are acceptable for Sevelamer Carbonate. PAR and 2 information can be found for same. The acceptance range was 80-125% in PAR.
Regards,
Divyen Shah
jansari
☆    

India,
2022-05-26 19:59
(124 d 13:13 ago)

@ dshah
Posting: # 23025
Views: 393
 

 Sevelamer Carbonate In vitro binding study for EMA submission

Dear divyen,

Thank you very much for providing this supporting documents to justify the query..bt this PAR published in the year 2014 and 2017..so my concern is that whether we have to justify the response with this reference docs?

As EU release one guidance documents for locally acting drug in GI tract in oct 2018.this guidance is not as much clear as us fda guidance..

but in this guidance on page no. 10 stated that in vitro similarity should be assessed with +-10%acceptance limit..so similarity should be proven based on T/R ratio or 90%CI needs to b calculate?

Reference doc's attached with this post..


Kindly guide on this...

Thnk you in advance.....


Edit: Send by email to the forum address. @Jansari: Reply directly in the forum in the future. THX. [Helmut]
dshah
★★  

India/United Kingdom,
2022-05-27 18:40
(123 d 14:33 ago)

@ jansari
Posting: # 23028
Views: 355
 

 Sevelamer Carbonate In vitro binding study for EMA submission

Dear janasari!
The link of PAR (Approved just before the Oct'18) is provided where the acceptance range is 80-120%. From guideline perspective, the 10% usually can be considered as CI.
Regards,
Divyen
jansari
☆    

India,
2022-05-27 18:54
(123 d 14:18 ago)

@ dshah
Posting: # 23029
Views: 402
 

 Sevelamer Carbonate In vitro binding study for EMA submission

Dear divyen,

We have already gone through this PAR.bt the same it's just before published guidance..so regulatory not accept this PAR..

And it's very difficult to pass the study in this acceptance range..it's very stringent range for sevelamer carbonate..and guidance doesn't provide any methodology like USFDA..


If you have any idea and submit sevelamer study in europe Market then please guide....


Thank you very much for your prompt reply and guidance...
UA Flag
Activity
 Admin contact
22,391 posts in 4,685 threads, 1,595 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time: Wednesday 09:13 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5