Sriramprasad
☆    

India,
2020-07-18 07:21
(221 d 20:31 ago)

(edited by Sriramprasad on 2020-07-18 08:46)
Posting: # 21739
Views: 485
 

 No RLD product [Design Issues]

Hello All,

Greetings!!

We want to know how to conduct a bioequivalence study with no RLD for indian regulatory submission (CDSCO). The particular test product is PPI drug Delayed release capsule 40 mg with dual delayed release technology (DDR) formulation and it provides two distinct drug release periods in the GI tract.

Test product (capsules) contain a mixture of pellets 20 mg (releases MT 70% in 45 min at pH 8.0 when it reaches proximal duodenum) &  EC DR tablets 20 mg (release MT 70% in 210 min at pH 7.4 distal portion of small intestine), each providing a different pH-dependent dissolution profile.

The RLD product is available for 20 mg strength with delayed release but it is not DDR in the US market. 

Please let me know your thoughts on this.

Thanks in advance.

Regards,
Sriram
Activity
 Admin contact
21,355 posts in 4,458 threads, 1,493 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Thursday 02:52 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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