Bioequivalence and Bioavailability Forum • Williams design 3-way

Williams design 3-way [Design Issues]

posted by Brus – Spain, 2021-06-10 16:33 (1417 d 18:55 ago) – Posting: # 22402
Views: 18,472

Hi Helmut,

❝ That’s not balanced for carryover. However, since we cannot correct for unequal carryover anyway (see there), we have to avoid it by design, i.e., sufficiently long washouts between treatment periods.

Why?

IMHO, in my 3x4x6 design proposal,

ABC
BAC
CAB
CBA

Eeach formulation is administered once per subject, occurs the same number of times in each period, and any formulation is preceded equally often by each of the other formulations. In this way it is a balanced design. What benefit does williams design bring?

❝ What is your idea behind such a design?

Make a balanced design with as few sequences as possible.

❝ Actually a simple Latin Square (ABC|BCA|CAB) would do as well. If you want to make European assessors happy, opt for the 6-sequence Williams’ design.

Will Simple Latin Square be accepted by EMA assessors? Will my proposal design be accepted by EMA assessors?

Best regards,

Complete thread:

Three-way crossover BABE Studies acfalcao 2007-09-16 22:34 [Design Issues]
- Three-way crossover example data set Helmut 2007-09-17 20:47
  - Three-way crossover example data set acfalcao 2007-09-17 23:02
    - Three-way crossover example data set Helmut 2007-09-18 12:47
      - Three-way crossover (WinNonlin) Nirali 2007-09-21 06:49
        
        Three-way crossover (WinNonlin) Helmut 2007-09-21 13:04
        
        Three-way crossover (WinNonlin) Nirali 2007-09-25 08:05
        
        Three-way crossover (WinNonlin) Helmut 2007-09-25 13:15
      - Three-way crossover example data set Irene_I 2018-06-07 11:09
        
        Three-way crossover example data set Helmut 2018-06-07 13:04
        
        Three-way crossover example data set Irene_I 2018-06-08 11:09
        Three-way crossover example data set Irene_I 2018-06-12 09:21
        
        Leave-One-Out (IBD) Helmut 2018-06-12 12:42
        
        Leave-One-Out (IBD) Irene_I 2018-06-13 05:02
        
        Impact of pooled variance (bias, CI) Helmut 2018-06-13 15:02
        
        carry (over?) d_labes 2018-06-13 15:31
  - Pseudo-periods ElAlumno 2019-03-14 23:40
    - Pseudo-periods Helmut 2019-03-15 00:47
      - Two‐at‐a‐Time analysis in R ElAlumno 2019-03-22 21:59
        
        fixed & mixed (dammit!) and a request to SASians Helmut 2019-03-23 01:03
        
        Pooled vs IBD T-R in SAS from non-SASian mittyri 2019-03-23 23:13
        
        Pooled vs IBD T-R in SAS from non-SASian Helmut 2019-03-23 23:36
        
        mixed in R mittyri 2019-03-23 23:50
        
        mixed in R (EMA B ≠ FDA) Helmut 2019-03-24 01:23
  - Williams design 3-way Brus 2021-06-09 16:48
    - Williams design 3-way Helmut 2021-06-09 17:48
      - Williams design 3-wayBrus 2021-06-10 14:33
        
        Williams design 3-way Helmut 2021-06-10 15:03
        
        Williams design 3-way vezz 2021-06-10 17:23
        
        Williams design 3-way Helmut 2021-06-10 20:14
        
        Williams design 3-way vezz 2021-06-11 09:11
        
        Williams design 3-way Brus 2021-06-11 12:19
        Williams design 3-way Relaxation 2021-06-11 12:42
        
        Period effects in general Helmut 2021-06-11 15:41
        Williams design 3-way vezz 2021-06-11 16:56