Bioequivalence and Bioavailability Forum • Phoenix

Phoenix [Regulatives / Guidelines]

posted by AngusMcLean – USA, 2014-11-12 20:25 (4248 d 12:00 ago) – Posting: # 13863
Views: 16,879

Thank you Helmut that appears to be fine:

The subject-by-formulation interaction variance is the variation in the average T and R difference in PK parameter among individuals.

The estimated lambda(2,2)_11 is the estimated variance for the subject×formulation interaction and is 8.3391924E-07 from the ABE Object in the Pharsight RSABE FDA template.

It seems we should be able to calculate the upper 95% confidence interval from the information we have. Now fundamentally exactly how do we do that? I am told by Ana that this was never included in the templates.

Angus

Complete thread:

Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 08:16
- Five PK metrics + S×F interaction Helmut 2014-11-10 13:57
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:26
    - Phoenix Helmut 2014-11-11 21:05
      - PhoenixAngusMcLean 2014-11-12 19:25
      - Phoenix AngusMcLean 2014-11-21 00:28
  - Five PK metrics + S×F interaction jag009 2014-11-16 03:39
    - Acceptance limit for the upper 95% confidence bound? Helmut 2014-11-17 12:49
      - Acceptance limit for the upper 95% confidence bound? jag009 2014-11-17 17:29
        
        Quoting László Helmut 2014-11-18 03:56
      - Acceptance limit for the upper 95% confidence bound? AngusMcLean 2014-11-19 13:28
  - Five PK metrics + S×F interaction kumarnaidu 2014-12-09 08:36
    - No RSABE Helmut 2014-12-09 13:18
      - No RSABE kumarnaidu 2014-12-09 14:19
        
        No RSABE Helmut 2014-12-09 14:50
- Five PK metrics + S×F interaction drgunasakaran1 2014-11-10 18:29
  - Five PK metrics + S×F interaction jag009 2014-11-11 18:04
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:22
    - Five PK metrics + S×F interaction jag009 2014-11-11 20:08
      - Tada! jag009 2014-11-13 20:17
        
        Tada! AngusMcLean 2014-11-13 23:06
        
        Tada! nobody 2014-11-19 09:30
        
        Tada! AngusMcLean 2014-11-19 13:42
        
        Tada! nobody 2014-11-19 13:55
        
        ABEL Helmut 2014-11-19 15:44
        
        ABEL nobody 2014-11-19 16:05
        
        ABEL Helmut 2014-11-19 16:59
        
        ABEL nobody 2014-11-19 17:10
        
        ABEL Helmut 2014-11-19 17:16
        
        ABEL AngusMcLean 2014-11-19 17:45
        
        Difficult formulations Helmut 2014-11-19 20:15
        
        Difficult formulations nobody 2014-11-19 21:04
        
        Difficult formulations Helmut 2014-11-19 21:49