Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-08-11 13:35 (1745 d 06:58 ago) – Posting: # 21855
Views: 2,492

Shlonak Ayman,

❝ […] do the metabolite (Favipiravir RTP) need to be measured or only the Favipiravir, since no FDA or EMEA related guidance issued till date.


Parent is always preferred, even if a pro-drug (FDA Section V.A.1., EMA Section 4.1.5). You have to know which dose(s) will be administered (FDA Section VI.B.1., EMA Section the 4.1.6). Please consult the relevant guidelines (FDA, EMA IR, MR) with answers to these questions at hand:

P.S.: The EMEA (European Agency for the Evaluation of Medicinal Products) was renamed to EMA (European Medicines Agency) back in 2005. ;-)

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
23,424 posts in 4,927 threads, 1,683 registered users;
51 visitors (0 registered, 51 guests [including 13 identified bots]).
Forum time: 20:33 CEST (Europe/Vienna)

Being really good at C++ is like being really good
at using rocks to sharpen sticks.    Thant Tessman

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