In vitro binding study for sevelamer carbonate for Europe submission [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2023-02-23 18:18 (368 d 20:53 ago) – Posting: # 23473
Views: 1,663

(edited by on 2023-02-23 19:32)

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]

Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
22,912 posts in 4,806 threads, 1,636 registered users;
30 visitors (0 registered, 30 guests [including 7 identified bots]).
Forum time: 15:12 CET (Europe/Vienna)

It is the peculiar and perpetual error of the human understanding
to be more moved and excited by affirmatives than negatives.    Francis Bacon

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