Bioequivalence and Bioavailability Forum • Problematic design

Problematic design [Design Issues]

posted by kumarnaidu – Mumbai, India, 2014-12-26 06:38 (4195 d 03:55 ago) – Posting: # 14176
Views: 20,354

Hi helmut,
Like kvgreddy I also encountered with same situation. We want to study the two test product and as per the literature the reference is HVD and some PK experts from CRO suggesting this design for pilot BE study. I suggested them to perform 3-way study with T1 T2 R as in pilot study we only want to know the T/R ratio. and the best test product will be used further for the pivotal (3way or 4way reference replicate) study. But my people also think that 4way pilot study with reference replicate will give them the correct idea.

CRO suggested the below sequence
T1 T2 R R
T2 R R T1
R R T1 T2
R T1 T2 R

Here the condition 2 is satisfied but not 3.

R : 2×P₁, 2×P₂, 2×P₃, 2×P₄

T1: 1×P₁, 1×P₂, 1×P₃, 1×P₄

T2: 1×P₁, 1×P₂, 1×P₃, 1×P₄

As you rightly said in your previous post that full balance could only be achieved if all 4! = 24 permutations are used which is imposible for the pilot study with 24 subjects.

Thanks

—
Kumar Naidu

Complete thread:

Two Tests with Same Reference Noha 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 designkumarnaidu 2014-12-26 05:38
        
        Two fully replicated designs? Helmut 2014-12-27 15:52