HVD(P)s? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-01-04 11:47 (1207 d 08:06 ago) – Posting: # 22167
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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.

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