Bioequivalence and Bioavailability Forum

Paper & Presentations [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2018-03-30 03:33 (2012 d 17:43 ago) – Posting: # 18622
Views: 9,198

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?)

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?

❝ NTI

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 #1 (June 2017), #2 (July 2017). In #1 navigate to page 51 and in #2 to page 57.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

Complete thread:

• [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 [RSABE / ABEL] 
  • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:07
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 19:23
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:44
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 20:05
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-28 21:25
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 21:59
              • [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
                • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
                  • Black Swan again mittyri 2018-04-05 17:57
  • [Opinion] Should the 90% CI for GMR be required to encompass 1 Helmut 2018-03-28 23:57
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 13:46
    • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 16:52
      • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 16:57
        • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
          • [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
            • [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
              • Paper & PresentationsHelmut 2018-03-30 01:33
            • Donald Schuirmann’s opinion Helmut 2018-04-10 14:41