HVD(P)s? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-01-04 10:47 (20 d 02:06 ago) – Posting: # 22167
Views: 275

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
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