Bioequivalence and Bioavailability Forum • Question

Question [Regulatives / Guidelines]

posted by AngusMcLean – USA, 2014-12-10 19:34 (4214 d 02:08 ago) – Posting: # 14050
Views: 16,622

ANA is the GURU:

SEE HER EMAIL

G(2,2) = sig_BR^2 = lambda(2,1)^2+lambda(2,2)^2

G(1,2) = rho*sig_BT*sig_BR = lambda(1,1)*lambda(2,1) (= between subject covariance for test and reference)

THE SIGMA SQUARED D calculation is shown in one of my posts from yesterday. The co variate term is subtracted from the sum of the other two parameters.

From Helmut's post above to the European document the following narrative is obtained.

This model allows a different subject effect for each formulation (i.e. a subject by formulation interaction), and therefore has 5 variance terms:

(1) Within subject for reference
(2) Within Subject for Test
(3) Between Subject for Test
(4) Between Subject for Reference
(5) Covariance for between subject test and reference

It also states the last three are "combined" to give the subject ×formulation interaction variance component.

From Ana’s letter the "combination" involves the addition of (3+4)-5.

Thread locked

Complete thread:

Concerta Guidance: Sub x Form interaction variance test jag009 2014-12-05 20:57
- Concerta Guidance: Sub x Form interaction variance test AngusMcLean 2014-12-06 01:28
  - Concerta Guidance: Sub x Form interaction variance test Helmut 2014-12-06 01:53
    - Concerta Guidance: Sub x Form interaction variance test jag009 2014-12-07 20:58
      - Concerta Guidance: S×F variance test AngusMcLean 2014-12-08 01:35
        
        Concerta Guidance: S×F variance test Helmut 2014-12-08 14:12
        
        Update: S×F variance test jag009 2014-12-08 17:40
        
        Update: S×F variance test AngusMcLean 2014-12-08 18:09
        
        EMA’s dataset I Helmut 2014-12-08 18:18
        
        EMA’s dataset I AngusMcLean 2014-12-08 19:55
        
        Update: S×F variance test jag009 2014-12-08 20:41
        
        Update: S×F variance test AngusMcLean 2014-12-08 18:18
        
        Question jag009 2014-12-10 17:01
        
        QuestionAngusMcLean 2014-12-10 18:34
        
        Update: S×F variance test kumarnaidu 2014-12-09 06:48
        
        Update: S×F variance test jag009 2014-12-09 15:16
        
        Update: S×F variance test AngusMcLean 2014-12-09 17:47
        
        Update: S×F variance test jag009 2014-12-09 18:01
        
        Update: S×F variance test AngusMcLean 2014-12-09 18:30
        
        Update: S×F variance test jag009 2014-12-18 15:31
        
        Update: S×F variance test AngusMcLean 2014-12-18 16:12
        
        Update: S×F variance test jag009 2014-12-22 17:28
        
        Update: S×F variance test AngusMcLean 2014-12-22 19:32
        
        Update: S×F variance test jag009 2014-12-22 20:19
        
        Update: S×F variance AngusMcLean 2014-12-22 20:45
        
        Update: S×F variance jag009 2014-12-22 20:51
        
        Update: S×F variance AngusMcLean 2014-12-22 21:10
        Update: S×F variance AngusMcLean 2014-12-22 21:36
        
        Update: S×F variance jag009 2014-12-22 22:18
        
        Update: S×F variance AngusMcLean 2014-12-22 23:26
        
        Update: S×F variance jag009 2014-12-23 04:43
        
        Update: S×F variance AngusMcLean 2014-12-23 15:24
        
        Update: S×F variance test AngusMcLean 2014-12-09 21:03
        
        Coding Helmut 2014-12-09 18:49
        
        working.... jag009 2014-12-09 22:24
- Concerta Guidance: S×F variance test ElMaestro 2014-12-06 11:12
  - Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 14:32
    - Concerta Guidance: S×F variance test ElMaestro 2014-12-07 18:08
      - Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 23:13
        
        Concerta Guidance: S×F variance test ElMaestro 2014-12-08 12:25
        
        Concerta Guidance: S×F variance test nobody 2014-12-08 13:44
        Concerta Guidance: S×F variance test AngusMcLean 2014-12-08 14:03
        
        Concerta Guidance:S×F variance test nobody 2014-12-08 14:32