Bioequivalence and Bioavailability Forum • Two Tests with Same Reference

Two Tests with Same Reference [Design Issues]

posted by Noha Abdeljawad – Cairo, Egypt, 2012-11-27 09:18 (4961 d 21:21 ago) – Posting: # 9598
Views: 27,529

Dear All,
In the bioequivalence center I work in, we need to carry out a BE study for two generic drugs containing the same active ingridient in the same strength from two different manufacturers. Since they both require using the same reference drug, we thought we'd do one crossover study of 3 phases, with one week (washout period) between each phase and the next. On each phase, each of the volunteers took test1 (A), test2 (B) or reference (C). By the end of the study, each of the three products will be adminstered to each volunteer. Bioequivalence assessment will be based on comparing PK parameters of A with C and then of B with C.

Is it ok to use this study design?
How will this affect ANOVA analysis?
Is this design referred to as two-way or three-way?

Thanks

—
Best Regards
Noha Abdeljawad

Complete thread:

Two Tests with Same ReferenceNoha Abdeljawad 2012-11-27 08:18
- Crossover designs with more than 2 treatments d_labes 2012-11-27 09:51
  - Crossover designs with more than 2 treatments Noha Abdeljawad 2012-11-29 07:43
- Sounds wrong to me ElMaestro 2012-11-27 12:10
  - Sounds wrong to me Dr_Dan 2012-11-27 14:32
  - Sounds wrong to me Noha Abdeljawad 2012-11-29 07:52
- Two Tests with Same Reference jag009 2012-11-28 21:26
  - FDA & multiplicity Helmut 2012-11-30 14:04
    - FDA & multiplicity jag009 2012-11-30 15:16
      - FDA & multiplicity Helmut 2012-11-30 16:12
        
        FDA & multiplicity jag009 2012-11-30 22:47
        
        FDA & multiplicity Helmut 2012-12-01 02:00
        
        FDA & multiplicity jag009 2012-12-03 21:53
    - Multiplicity: Mixed feelings ElMaestro 2012-11-30 15:24
      - Multiplicity: Mixed feelings Helmut 2012-11-30 15:52
        
        Multiplicity: Mixed feelings martin 2012-12-03 09:24
      - Multiplicity: Mixed feelings kumarnaidu 2013-12-12 11:03
        
        More infos, please Helmut 2013-12-12 15:27
  - Two Tests with Same Reference Noha Abdeljawad 2012-12-03 08:29
    - Two Tests with Same Reference jag009 2012-12-03 15:35
      - X-way d_labes 2012-12-04 09:25
        
        design kvgreddy06 2013-12-19 15:32
        
        design kvgreddy06 2013-12-30 16:48
        
        design intuitivepharma 2013-12-31 06:44
        
        design kumarnaidu 2013-12-31 08:24
        
        Problematic design Helmut 2013-12-31 15:02
        
        Problematic design kvgreddy06 2014-01-03 14:46
        Problematic design kumarnaidu 2014-12-24 12:56
        
        Problematic design Helmut 2014-12-24 16:10
        
        Problematic design kumarnaidu 2014-12-26 05:38
        
        Two fully replicated designs? Helmut 2014-12-27 15:52