Bioequivalence and Bioavailability Forum • Dead dogs

Dead dogs [Regulatives / Guidelines]

posted by mittyri – Russia, 2020-06-07 22:32 (1205 d 13:42 ago) – Posting: # 21505
Views: 10,933

Hi Helmut,

❝ If you have a lot of time and nothing better to do, perform simulations. On my to-do list for ages. Currently in the “dead dogs” folder of my machine.

I had in mind more simplistic approach: shiny app to give points, parameters of 2cpt model and to see what parameters will give ratio less than 80%.
I like 'dead dogs', will rename it :-)

❝ … должно быть ≈ should be or must be? :-D

❝ In guidelines commonly “should be” is used. What’s your interpretation of the Russian original? Does it smell of a recommendation or rather a requirement?

That's a matter of expert's taste and mood :cool:

see later:

Однако если AUC(0–t) не перекрывает 80 процентов AUC(0–∞) в более чем 20 процентах случаев, следует усомниться в результатах такого исследования.

Are you good enough to extinguish doubts from expert's mind? You never know!

❝ Which version of Phoenix are you using?

That rule is not changed for decades in Winnonlin.

❝ The value of the last triangle depends on the time interval between the time point of the last measured concentration and the next one with C=0. You would only get a meaningful result if (1) you use the lin-up/log-down trapezoidal and (2) the interval equals t_½. Since (2) is never fulfilled for all profiles, forget it.

Regarding (1): lin-up/log-down is overriden by linear rule if the end point is non-positive.

—
Kind regards,
Mittyri

Complete thread:

AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-05 08:30 [Regulatives / Guidelines]
- AUCt not covering at least 80% of AUCinf d_labes 2013-03-05 11:12
  - AUCt not covering at least 80% of AUCinf ratnakar1811 2013-03-06 08:50
    - AUCt not covering at least 80% of AUCinf ElMaestro 2013-03-06 11:10
      - ADME-tox? Helmut 2013-03-06 14:35
        
        ADME-tox? ElMaestro 2013-03-06 16:40
        
        OT Helmut 2013-03-06 17:19
        
        OT ElMaestro 2013-03-07 17:19
        
        OT Helmut 2013-03-07 17:26
    - Science vs. regulations Helmut 2013-03-06 14:30
      - Science vs. regulations cakhatri 2013-03-10 08:59
        
        ratio = difference of logs! Helmut 2013-03-11 01:17
      - Science vs. (EMA) GL aka PK primer Helmut 2013-03-11 03:17
      - Science vs. regulations qualityassurance 2020-04-23 14:11
        
        Science vs. regulations Helmut 2020-04-23 17:32
        
        Science vs. regulations Achievwin 2020-05-07 22:59
        
        Science vs. regulations Helmut 2020-05-07 23:54
    - AUCt not covering at least 80% of AUCinf Brus 2018-11-20 13:01
      - AUCt not covering at least 80% of AUCinf Astea 2020-06-05 19:05
        
        So what? Helmut 2020-06-06 12:02
        
        Carrot and whip Astea 2020-06-06 21:11
        
        Gedankenexperiment Helmut 2020-06-07 12:41
        
        Dead dogsmittyri 2020-06-07 20:32
        
        Aber meine Herren das ist keine physik Astea 2020-06-08 00:08
        
        Aber meine Dame, das ist alles Unsinn! Helmut 2020-06-08 01:04
        Bizarre paper Helmut 2020-06-08 12:43
        
        Bizarre paper ElMaestro 2020-06-08 15:33
        
        OT: Bias of AUCt, AUCall, pAUC Helmut 2020-06-08 15:53
        
        OT: Bias of AUCt, AUCall, pAUC ElMaestro 2020-06-09 08:45
        
        OT: Bias of AUCs; example Helmut 2020-06-09 14:07
        
        Maxwell's demon Astea 2020-06-12 14:15
        
        Dead dogs Helmut 2020-06-08 10:40