Paper & Presentations [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2018-03-30 01:33 (1601 d 17:38 ago) – Posting: # 18622
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Hi John,

» If I recall (or I am imagining things), FDA published a paper about NTI drug BE assessment (Helmut, help! Am I hallucinating again?)

[image]Too much absinthe? I guess you mean this goody:

Yu LX, Jiang W, Zhang X, Lionberger R, Makhlouf F, Schuirmann DF, Muldowney L, Chen M-L, Davit B, Conner D, Woodcock J. Novel Bioequivalence Approach for Narrow Thera­peutic Index Drugs. Clin Pharmacol Ther. 2015;97(3):286–91. doi:10.1002/cpt.28.

» Anyhow, Have you looked at this FDA slide presentation before?

Yep. There are others with more background information. Most simulations were performed in R – Donald told me in 2016 that he grew up with APL and finds R difficult… See also this post. The presentations are gone with the wind. Webarchive [image] #1 (June 2017), [image] #2 (July 2017). In #1 navigate to page 51 and in #2 to page 57.

Dif-tor heh smusma 🖖 [image]
Helmut Schütz

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