Bioequivalence and Bioavailability Forum • Five PK metrics + S×F interaction

Five PK metrics + S×F interaction [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2014-11-10 14:57 (4240 d 21:12 ago) – Posting: # 13850
Views: 16,955

Hi Kumar,

THX for posting! These requirements will be tough to meet.

Sep 2012
- 2×2 cross-over studies
- Fasting
  C_max, AUC_0-T, AUC_T-t, AUC_∞; where T = 3 h.
- Fed
  As above, but T = 4 h.
Nov 2014
- 4-period fully replicated studies
- Fasting
  C_max, AUC_0-T1, AUC_T1-T2, AUC_T2-T3, AUC_∞; where T1 = 3 h, T2 = 7 h, and T3 = 12 h.
- Fed
  As above; but T1 = 4 h and T2 = 8 h.
- In both studies estimate the subject-by-formulation interaction σ²_D. Its upper 95% CL should be ≤0.03.

Submit your comments to regulations.gov until Jan 5, 2015.

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Complete thread:

Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 08:16 [Regulatives / Guidelines]
- Five PK metrics + S×F interactionHelmut 2014-11-10 13:57
  - Five PK metrics + S×F interaction AngusMcLean 2014-11-11 19:26
    - Phoenix Helmut 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