Bioequivalence and Bioavailability Forum • Phoenix

Phoenix [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-11-11 22:05 (4248 d 11:16 ago) – Posting: # 13862
Views: 16,988

Hi Angus,

❝ Can the (subject by formulation) interaction be done in Phoenix WinNonlin?

You don’t need the templates. Run conventional ABE with the default setup:

Fixed Effects: Sequence+Period+Formulation Variance Structure > Random 1: Random Effects: Formulation Variance Blocking Variables: Subject Type: Banded No-Diagonal Factor Analytic(f), Number of factors = 2 Variance Structure > Repeated: Repeated Specification: Period Variance Blocking Variables: Subject Group: Formulation Type: Variance Components

Final Variance Parameters > lambda(2,2)_11 is the estimated subject×formulation interaction, Var(Period*Formulation*Subject)_21 is σ²_wR, and Var(Period*Formulation*Subject)_22 is σ²_wT. It should be possible to merge the degrees of freedom, get cinv(0.05, df), and calculate the upper bound directly. Have to check. If not, all the necessary data to follow Step 4 of the guidance are available.

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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
    - PhoenixHelmut 2014-11-11 21:05
      - Phoenix AngusMcLean 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