Bioequivalence and Bioavailability Forum • Scaling of Cmin

Scaling of Cmin [Regulatives / Guidelines]

posted by VStus – Poland, 2017-02-03 16:37 (3012 d 00:10 ago) – Posting: # 17008
Views: 12,252

Dear zizou,

Thank you very much for the feedback!

I've tried 4 periods instead of 2 and got even higher variation, which seems to be an overestimation:


summary(data)

##       subj    seq     prd    drug   rep          AUC        

##  1      : 2   RT:20   1:10   R:40   R1:20   Min.   : 439.0  

##  2      : 2   TR:20   2:10          R2:20   1st Qu.: 656.5  

##  3      : 2           3:10                  Median : 781.5  

##  4      : 2           4:10                  Mean   : 795.6  

##  5      : 2                                 3rd Qu.: 929.8  

##  6      : 2                                 Max.   :1297.0  

##  (Other):28

anovadata <- lm(log(AUC) ~ seq + subj:seq + rep + prd, data=data, na.action=na.exclude)

anova(anovadata)

## Analysis of Variance Table

## 

## Response: log(AUC)

##           Df  Sum Sq  Mean Sq F value  Pr(>F)  

## seq        1 0.20989 0.209885  6.2514 0.02230 *

## rep        1 0.00507 0.005067  0.1509 0.70222  

## prd        1 0.00169 0.001689  0.0503 0.82505  

## seq:subj  18 1.55131 0.086184  2.5670 0.02631 *

## Residuals 18 0.60433 0.033574                  

## ---

## Signif. codes:  0 '***' 0.001 '**' 0.01 '*' 0.05 '.' 0.1 ' ' 1

100*sqrt(exp(0.033574)-1)

## [1] 18.47812

Removing replication from the model does not change residual MS :)

Regards, VStus

Complete thread:

Type of study in modified release formulation EMEA Compliance 2014-03-13 09:43 [Regulatives / Guidelines]
- Type of study in modified release formulation EMEA nobody 2014-03-13 09:52
- Type of study in modified release formulation EMEA fno 2014-03-13 11:16
  - Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 11:02
    - Type of study in modified release formulation EMEA nobody 2014-11-27 11:37
      - Type of study in modified release formulation EMEA kumarnaidu 2014-11-27 12:53
        
        Scaling of Cmin Helmut 2014-11-27 13:47
        
        Scaling of Cmin kumarnaidu 2014-11-27 15:12
        Scaling of Cmin kumarnaidu 2014-12-05 06:03
        
        Steady state kumarnaidu 2014-12-10 11:15
        
        Steady state nobody 2014-12-10 17:04
        
        Scaling of Cmin Dr_Dan 2014-12-10 17:21
        
        Scaling of Cmin Helmut 2014-12-10 18:40
        
        Scaling of Cmin d_labes 2014-12-11 13:09
        
        Scaling of Cmin Helmut 2014-12-11 14:53
        
        Scaling of Cmin VStus 2017-02-03 13:04
        
        Scaling of Cmin zizou 2017-02-03 13:49
        
        Scaling of CminVStus 2017-02-03 15:37
        Scaling of Cmin VStus 2017-02-06 08:55