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

posted by ElMaestro  – Denmark, 2018-10-16 18:35  – Posting: # 19457
Views: 613

Hello Mikalai,

» Are there any explicit recommendations or guidelines from EMA about how to establish bio-equivalence for nasal sprays with steroids?

There is nothing specific yet but they are working on it.

» 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.

You need a scientific advice. There are a ton of companies selling in vitro tests in various flavours and colors and the best I can say of them is that without a scientific advice each and every of those tests may from a regulatory perspective be as good as the south end of a nort-bound horse.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1


Best regards,
ElMaestro

“(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures.” New York Times (ed.), June 9, 2018.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,404 posts in 4,122 threads, 1,323 registered users;
online 6 (1 registered, 5 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 17:01 UTC

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5