Bioequivalence and Bioavailability Forum

Phoenix [Regulatives / Guidelines]

posted by AngusMcLean – USA, 2014-11-21 01:28 (4234 d 17:05 ago) – Posting: # 13896
Views: 15,913

Helmut: Again I looked at he subject by formulation interaction from the Pharsight progesterone template it is a rather small number {8.3391924E-07 from the ABE Object in the RSABE FDA template, final variance paramaters tab}

This number is taken from "Final Variance Parameters > lambda(2,2)_11 is the estimated subject×formulation"

I am wondering am I misunderstanding the outpput. Surely it is way too low, I looked at a stick plot of the repsonse variable (AUC)




Please can you comment,

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
        • Phoenix AngusMcLean 2014-11-12 19:25
        • PhoenixAngusMcLean 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