Product-specific advice (steroid nasal sprays) [Design Issues]

posted by Mikalai  – Belarus, 2018-10-16 13:42 (1017 d 18:25 ago) – Posting: # 19451
Views: 2,336

(edited by Mikalai on 2018-10-16 15:35)

Dear friends,
Are there any explicit recommendations or guidelines from EMA about how to establish bio-equivalence for nasal sprays with steroids? More specifically, how can we avoid a therapeutic equivalence study, European approach? Are there any recommendations on Morphologically-Directed Raman Spectroscopy (MDRS) as a substitute for a therapeutic equivalence study? Any references will be appreciated.

Complete thread:

Activity
 Admin contact
21,592 posts in 4,514 threads, 1,532 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Friday 08:08 CEST (Europe/Vienna)

It is a capital mistake to theorise before one has data.    Arthur Conan Doyle

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