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

posted by jansari  – India, 2023-02-24 16:24 (451 d 18:24 ago) – Posting: # 23474
Views: 1,980

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.

[image]


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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