Bioequivalence and Bioavailability Forum • ANOVA_stat.txt is correct. → bear for imbalanced data set

ANOVA_stat.txt is correct. → bear for imbalanced data set [🇷 for BE/BA]

posted by yjlee168 – Kaohsiung, Taiwan, 2013-03-01 02:01 (4441 d 07:03 ago) – Posting: # 10137
Views: 14,096

Dear Oiinkie, Helmut and yicaoting

Thank you all for running WNL (by Helmut) and SAS (by yicaoting) for imbalanced data provided by Oiinkie. This is definitely a great Forum.
O.K., bear will crash with incomplete data. The original question was: with imbalanced data, bear got two output files (ANOVA_stat.txt and Statistical_summaries.txt). The results showed inconsistent. After running the imbalance data, it can be concluded:

the result of ANOVA_stat.txt is correct based on WNL & SAS runs. Oiinkie probably has already known that.
the PE from Statistical_summaries.txt is also incorrect as pointed by Oiinkie.
the error only occurs in imbalanced data; for incomplete data, bear will be crashed.

I will try to fix these errors/bugs asap. Finally, I am very sorry to keep you all waiting, as well as any inconveniences due to these errors/bugs.
I only abstract the differences as mentioned by Oiinkie as follows:


[from ANOVA_stat.txt]
...

*** Classical (Shortest) 90% C.I. for lnCmax ***



        Point Estimate   CI90 lower   CI90 upper

Ratio          104.758       99.607      110.176



---------------------- Two One-Sided Tests (TOST) -------------------------



     TOST   T value   P value

1 T_lower    -9.141     0.000

2 T_upper    -6.089     0.000



**Interpretation:

Ho: Theta <  0.80000  or  Theta >  1.25000 

Ha:  0.80000  < or = Theta < or =  1.25000 

where Theta = Mean_Test/Mean_Ref.

Because all P values are less than 0.05, we will reject the null hypothesis (Ho). 

BE acceptance criterion is set within the range of  80.000  -  125.000 % .

...

Intra_subj. CV = 9.953 %

...

and


[from Statistical_summaries.txt]
...

Statistical Summaries for Pivotal Parameters of Bioequivalence (N= 23 )

(cont'd)

-------------------------------------------------------------------------



    Parameters  F values  P vales    PE (%)  lower 90%CI   upper 90%CI

1         Cmax     1.643    0.214         -            -            -

2       AUC0-t     1.466    0.239         -            -            -

3     AUC0-inf     1.286    0.270         -            -            -

4     ln(Cmax)     2.516    0.128   104.573       99.4304      109.981  ← Error!

5   ln(AUC0-t)     1.330    0.262   103.317       98.5645      108.299

6 ln(AUC0-inf)     1.173    0.291   103.239       98.2956      108.433

...

ps. please ignore AUC stuffs. I just arbitrarily put 100 as the the given dose in order to complete the run with bear.

ps2: A good news is that I think the inconsistency has been fixed back to 2011-12-22 (bear v2.5.4, not released to the public yet). However, the crash with incomplete data has been not yet.[edited]

❝ Have you already been able to test the data set in order to find out whether ANOVA_stat.txt or Statistical_summaries.txt gives the "correct answer"? This would help me a lot.

—
All the best,
-- Yung-jin Lee
bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

bear for imbalanced data set Oiinkie 2013-01-16 16:42 [🇷 for BE/BA]
- bear for imbalanced data set yjlee168 2013-01-16 17:25
  - bear for imbalanced data set Oiinkie 2013-01-16 19:18
  - bear for imbalanced data set Oiinkie 2013-01-16 19:19
    - bear for imbalanced data set yjlee168 2013-01-16 19:43
      - bear for imbalanced data set ElMaestro 2013-01-16 22:10
      - bear for imbalanced data set Oiinkie 2013-01-22 13:28
        
        comparison with PHX Helmut 2013-01-22 15:06
        
        comparison with PHX Oiinkie 2013-01-23 12:58
        
        comparison with PHX Oiinkie 2013-01-23 15:07
        
        comparison with SAS yicaoting 2013-02-15 18:58
        
        bear for imbalanced data set yjlee168 2013-01-22 19:57
        ANOVA_stat.txt is correct. → bear for imbalanced data setyjlee168 2013-03-01 01:01
        
        bear for incomplete data set? yjlee168 2013-03-15 07:58
- imbalanced or incomplete data yicaoting 2013-02-15 18:48
  - incomplete data Helmut 2013-02-16 14:41