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

posted by Mikalai  – Belarus, 2018-10-16 13:42 (1201 d 00:44 ago) – Posting: # 19451
Views: 2,459

(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:

 Admin contact
21,858 posts in 4,574 threads, 1,554 registered users;
online 19 (0 registered, 19 guests [including 15 identified bots]).
Forum time: Saturday 13:26 CET (Europe/Vienna)

Truth in science can be defined as the working hypothesis best suited
to open the way to the next better one.    Konrad Lorenz

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