HVD(P)s? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-01-04 10:47 (329 d 11:19 ago) – Posting: # 22167
Views: 996

Hi 0521,

» But can you first clarify the acronym for "GL"?
» Please try not to use any abbreviations, which makes it painful for non-native English speakers to understand.

Sorry. In the future & if in doubt see the [image] Abbreviations on top of the page.

» "Guidance for Industry"?
» "Guidelines"?

Any would do.

» If it is "Guidelines", what kind of "Guidelines" do you want to get?
» RSABE? ABE?

Abbreviations, right? :-D
I was interested in the former but the latter would be fine as well.

» Maybe what you want is this: …

Almost! Seemingly it is for reference-scaling of narrow therapeutic index drugs. I’m looking for reference-scaling of highly variable drugs / drug products HVD(P)s.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,778 posts in 4,555 threads, 1,547 registered users;
online 12 (1 registered, 11 guests [including 9 identified bots]).
Forum time: Monday 22:07 CET (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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