No reference-scaling for NTIDs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-08-02 16:57 (860 d 15:39 ago) – Posting: # 22498
Views: 1,809

Hi Prasad,

❝ Little bit confusion raised as the Gliclazide is a NTI molecule, what would be the study design for gliclazide 80mg tablet BE study for Europe, WHO & HKG submission.


If you are referring to Hong Kong, guidances of China’s CDE are applicable.

Adding to what vixen wrote: Reference-scaling (ABEL: the EMA, most jurisdictions including the WHO or RSABE: U.S. FDA and China’s CDE) for NTIDs is not acceptable.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,823 posts in 4,786 threads, 1,632 registered users;
26 visitors (0 registered, 26 guests [including 8 identified bots]).
Forum time: 07:36 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

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