HVD(P)s? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-01-04 10:47 (508 d 08:35 ago) – Posting: # 22167
Views: 1,184

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 🖖 [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
22,110 posts in 4,630 threads, 1,567 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Friday 20:23 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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