Bioequivalence and Bioavailability Forum • Sims & evaluation

Sims & evaluation [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2013-08-30 11:16 (4275 d 08:18 ago) – Posting: # 11392
Views: 9,825

Dear ElMaestro

❝ How is the evaluation done? Which model is fitted?

EMA ANOVA:

Sims according to the 'all effects fixed' doctrine as discussed here.
Evaluation of the replicate design with the same ANOVA as for the 2x2x2 crossover. Point estimator and its 90% CI via LSMeans difference.
ABE decision via 90% CI's.

FDA ISC:

Sims with the full mixed model underlying the Proc MIXED code of the FDA. We had it already here in the forum but couln't find at the moment in the meanwhile tons of posts. For a short description see Chow&Liu Chapter 20.5.7.1.. The subject-by-treatment interaction was assumed zero.
Calculate appropriate intra-subject contrast to obtain individual T-R. Analyzed them by an ANOVA with sequence as the solely effect. The intercept of this ANOVA gives the point estimator T-R and its 90% CI.
ABE decision via the 90% CI's.

—
Regards,

Detlew

Complete thread:

3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-12 19:54
- 3-per, 2-trt designs and estimation of intra-subj. variance Dr_Dan 2013-08-13 10:11
  - 3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-13 15:00
    - TRT|RTR rulez! Helmut 2013-08-13 18:23
      - TRT|RTR rulez? Really? d_labes 2013-08-14 08:16
        
        TRT|RTR rulez? Really? Yes. ElMaestro 2013-08-14 11:29
        
        TRT|RTR rulez? Really? No. d_labes 2013-08-14 13:34
        
        TRT|RTR rulez? Really? No. ElMaestro 2013-08-14 14:25
        
        TRT|RTR Lost in formulas. d_labes 2013-08-14 16:35
        
        TRT|RTR rulez? References Helmut 2013-08-14 13:44
        
        References László & László d_labes 2013-08-14 19:12
        
        Heteroscedasticity Helmut 2013-08-17 17:33
        
        Heteroscedasticity: TRT|RTR rulez! d_labes 2013-08-29 16:45
        
        Heteroscedasticity: TRT|RTR rulez! ElMaestro 2013-08-29 17:50
        
        Sims & evaluationd_labes 2013-08-30 09:16
        
        Sims & evaluation ElMaestro 2013-08-31 14:11
        
        Evaluation subtleties d_labes 2013-08-31 17:20

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