Bioequivalence and Bioavailability Forum

ABEL [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2014-11-19 17:59 (4236 d 02:38 ago) – Posting: # 13887
Views: 16,308

Hi nobody,

❝ Why not interchangeable when MA was granted based on BE-studies for at least one formulation? Could you provide some details on the reasons?

This particular one was BE to Concerta and no clinical studies were performed. The other products stand on their own (clinical data) and these two papers show lack of BE between them.

❝ PS: Found somefink interesting, a strange company called BEBAC has apparently been digging deep into methylphenidate in the past...

Well yes, though I didn’t support Hexal in this project. My presentations are licensed and they quoted the source correctly. But they used it for com­mer­cial pur­poses (violating the license). Shall I sue them?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 08:16 [Regulatives / Guidelines] 
  • 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 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
                      • ABELHelmut 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