Bioequivalence and Bioavailability Forum • Baseline; another example

Baseline; another example [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2016-02-12 14:37 (2989 d 14:35 ago) – Posting: # 15981
Views: 16,259

Hi nobody,

❝ Can we start a diploma thesis…

THX, not interested.

❝ … with adding some more random effects on the baseline (physiology jumps around like hell in practice, due to health status, sports, sleep, food etc.). Would love to see a large set of simulations taking into account all that!

Me too.

❝ Some 20 years ago I set up some S-plus simulations "retro-NONMEM" with true values and all kinds of variability to study the potential influence of analytical variability on BE decisions.

Haha, welcome to the club! I had even to crazy idea to optimize the number and location of calibrators based on PK (objective function: Minimize the RE of back-calculated concentrations). Trashed.

❝ Unfortunately never finished (end of academic time :-D ) and lost the files while moving over from one computer to the next in the pre-NAS era...

Do you mean the NSA? The impact of bioanalytics on the outcome BE-studies is overrated anyhow. Unless the method is (really!) lousy, analytical variability contributes little to total variability (mainly biological noise).*

Gaffney M. Variance Components in Comparative Bioavailability Studies. J Pharm Sci. 1992; 81(4): 315–7. doi:10.1002/jps.2600810402.

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Helmut Schütz

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Complete thread:

Baseline correction vs non-baseline correction jag009 2015-09-15 20:29 [Regulatives / Guidelines]
- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
  - Baseline correction vs non-baseline correction Relaxation 2015-09-18 10:25
- Baseline correction or supra-therapeutic dose Helmut 2015-09-16 15:16
  - Baseline correction or supra-therapeutic dose Ohlbe 2015-09-16 17:55
    - Baseline profile prior to each period? Helmut 2015-09-16 18:15
    - Baseline correction examples Helmut 2015-09-17 15:44
      - Baseline correction examples Lucas 2015-09-18 14:19
        
        Baseline correction examples Helmut 2015-09-18 17:28
        
        Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
        
        Baseline correction examples Lucas 2016-02-10 11:48
        
        Postmenopausal women Helmut 2016-02-10 12:26
        Baseline correction examples Mauricio Sampaio 2016-02-11 01:38
        Baseline correction examples Dr_Dan 2016-02-11 09:22
        
        Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
        
        Postmenopausal women Dr_Dan 2016-02-15 17:45
    - Baseline; another example Helmut 2015-09-18 17:16
      - Baseline; another example nobody 2016-02-12 09:10
        
        Baseline; another exampleHelmut 2016-02-12 13:37
        
        Baseline; another example nobody 2016-02-12 14:08
        
        Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
        
        Slowly going OT: BE study simulations nobody 2016-02-12 16:15
        
        Religious debate Helmut 2016-02-12 17:04
        
        Religious debate nobody 2016-02-12 17:26
        
        Religious debate ElMaestro 2016-02-13 12:53
        
        Religious debate nobody 2016-02-14 15:23
        
        Slowly going OT: BE study simulations Ohlbe 2016-02-13 13:10
        
        Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
        
        Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
        
        Business as usual Helmut 2016-02-25 17:44
        
        Business as usual lizhao 2016-02-25 17:59