Bioequivalence and Bioavailability Forum • Egypt: Strange requirements

Egypt: Strange requirements [🇷 for BE/BA]

posted by mahmoud-teaima – 2016-07-20 16:12 (3134 d 22:13 ago) – Posting: # 16499
Views: 10,354

Thanks Helmut for the prompt detailed fully scientific and statistically logic answers which i totally agree with you.
Unfortunately things don't run fully according to book here.
The official Egyptian guidelines to conduct BE studies totally agree with your words, but some members of the committee for evaluation of BE studies may insist on requests like the ones formentioned in my first post. that is why i see it will be helpful if bear can do such extra calculations.

Herein below is an example of data submitted before:

t-half

SOURCE       D.F     SS        MS        F         p

Period         1   8.53E-03  8.53E-03  7.04E-03  0.9339

Subject(Seq)  22  24.9975    1.13625   0.937355  0.5596

Formulation    1   1.48403   1.48403   1.22426   0.2805

Sequence       1   7.68      7.68      6.33565   0.01962

Error         22  26.6681    1.21219

Total         47  60.8382



k

SOURCE       D.F    SS        MS        F         p

Period         1  3.74E-04  3.74E-04  0.025692  0.8741

Subject(Seq)  22  0.78587   0.035721  2.45336   0.02028

Formulation    1  1.29E-02  1.29E-02  0.888474  0.3561

Sequence       1  0.117216  0.117216  8.05048   0.009586

Error         22  0.320324  1.46E-02

Total         47  1.23672





  Kruskal Wallis  DESIGN for tmax



N = 48



Si[1] = 595.5 ; ni[1] = 24

Si[2] = 580.5 ; ni[2] = 24



  H =             0.026032

  Mean Rank[1] = 24.81

  Mean Rank[2] = 24.19

  Chi Square ( 0.95 -   1 ) = 3.841



The difference between means is not significant.

I really don't know how these calculations were done, my guess it may be done by winnonlin!!!!!!

Edit: Tabulators changed to spaces and BBcoded; see also this post #6. [Helmut]

—
Mahmoud Teaima, PhD.

Complete thread:

ANOVA for lambdaz, half life and tmax in bear 2.7.7 mahmoud-teaima 2016-07-20 11:03 [🇷 for BE/BA]
- Egypt: Strange requirements Helmut 2016-07-20 12:25
  - Egypt: Strange requirementsmahmoud-teaima 2016-07-20 14:12
    - Output is not from Phoenix/Winnonlin mittyri 2016-07-20 17:00
  - ke versus t1/2 d_labes 2016-07-20 16:05
    - ke versus t1/2 Helmut 2016-07-20 16:31
      - ke versus t1/2 d_labes 2016-07-21 14:42
        
        “double“ testing Helmut 2016-07-21 14:54
- tmax in bear 2.7.7 yjlee168 2016-07-20 21:10
  - tmax in bear 2.7.7 mahmoud-teaima 2016-07-20 22:40
    - tmax in bear 2.7.7 yjlee168 2016-07-21 11:11
      - tmax results in R 3.3.1 and spss 20 on macos 10.11.6 mahmoud-teaima 2016-07-27 12:13