No RLD product [Design Issues]

posted by Sriramprasad – India, 2020-07-18 07:21 (709 d 22:25 ago) – Posting: # 21739
Views: 947

(edited by Sriramprasad on 2020-07-18 08:46)

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

Complete thread:

UA Flag
Activity
 Admin contact
22,178 posts in 4,646 threads, 1,571 registered users;
online 18 (0 registered, 18 guests [including 7 identified bots]).
Forum time: Tuesday 05:47 CEST (Europe/Vienna)

It is futile to do with more things
that which can be done with fewer.    William of Ockham

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