Bioequivalence and Bioavailability Forum

No RSABE [Regulatives / Guidelines]

posted by kumarnaidu – Mumbai, India, 2014-12-09 15:19 (4213 d 13:01 ago) – Posting: # 14034
Views: 15,030

Hi Helmut,
Actually one of my friend recently did this study and according to him he is getting ISCV around 32% for one of the partial AUCs and the upper limit of T/R ratio for that parameter is 127%. And he planning to use scaled approach.

One more thing for one of the parameter he is getting σ²D >0.03 and the T/R ratio within 80 to 125 (borderline pass). How to justify here ?
(I dont know how he completed this study in one month)

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
        • 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 RSABEkumarnaidu 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