Abridged application for modified release forms [Regulatives / Guidelines]

posted by Jignesh S Kotecha – India, 2019-05-12 18:53 (507 d 02:17 ago) – Posting: # 20280
Views: 982

We are developing a prolonged release tablet for Europe market. This product has got single strength. The therapeutic doses is achieved with this single strength by increasing the number of tablets per day in three divided doses. These doses should be attained slowly, by step-wise increase by one tablet every two weeks.

We are required to conduct a single dose fasting, single dose fed and multiple dose study in fed condition. Since this product has single strength and dose is increased to therapeutic level step-wise, can we conduct the multiple dose study at given strength considering it as a sensitive strength?


Edit: Please follow the Forum’s Policy[Helmut]

Complete thread:

Activity
 Admin contact
21,090 posts in 4,398 threads, 1,469 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Wednesday 21:11 CEST (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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