Bioequivalence and Bioavailability Forum

FDA: Prasugrel [Regulatives / Guidelines]

posted by intuitivepharma – India, 2013-12-20 08:36 (4566 d 18:05 ago) – Posting: # 12084
Views: 31,675

Dear Helmut,

How about this bioequivalence requirement [based on USFDA individual product bioequivalence recommendations] for Prasugrel Hydrochloride

Active ingredient: Prasugrel Hydrochloride

Analytes to measure (in appropriate biological fluid): Inactive metabolite R-95913 and active metabolite R-138727 in plasma.

Bioequivalence based on (90% CI): Inactive metabolite R-95913.

Please submit the data of active metabolite (R-138727) including individual and mean concentrations, individual and mean pharmacokinetic parameters, and geometric means and ratios of means for AUC and Cmax, as supportive evidence of comparable therapeutic outcome.

Can I justify my ANDA if test formulation is bioequivalent for the active metabolite (R-138727) and not bioequivalent for the Inactive metabolite R-95913?

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Edit: Subject line changed. [Helmut]

Complete thread:

• Bioequivalence Recommendations for Specific Pro­ducts cr.maroj 2013-09-19 11:00 
  • Bioequivalence Recommendations for Specific Pro­ducts Ohlbe 2013-09-19 11:45
    • EMA: Draft product-specific guidances ♬ Helmut 2013-11-15 15:45
      • EMA: Draft product-specific guidances ♬ luvblooms 2013-11-19 06:35
      • EMA: Capecitabine product-specific guidance ♬ mittyri 2013-12-10 15:33
        • EMA: Capecitabine product-specific guidance ♬ Helmut 2013-12-10 16:11
          • Russian GL 2013: harmonisation to EMA mittyri 2013-12-14 11:57
      • EMA: Draft product-specific guidances ♬ pash413 2013-12-18 12:35
        • EMA: Use of AUC72 not dependent on t½ Helmut 2013-12-18 14:35
      • End of consultation approaching‼ Helmut 2014-02-10 18:33
        • End of consultation approaching‼ Dr_Dan 2016-01-28 09:27
          • Guesstimates Helmut 2016-01-28 13:32
  • EMA: generally no product-specific GLs Helmut 2013-09-19 11:48
    • Thank you cr.maroj 2013-09-19 13:03
    • EMA: generally no product-specific GLs The Outlaw Torn 2013-09-20 07:52
      • EMA: parent whenever possible Helmut 2013-09-20 09:02
        • EMA: parent whenever possible cr.maroj 2013-09-20 10:14
          • EMA: parent whenever possible Helmut 2013-09-20 12:53
            • EMA: parent whenever possible Ohlbe 2013-09-20 13:52
              • EMA: parent whenever possible mittyri 2013-09-20 14:55
                • EMA vs. Russia Helmut 2013-09-20 19:21
                  • FDA: Prasugrelintuitivepharma 2013-12-20 07:36
                    • FDA: Prasugrel Helmut 2013-12-20 13:46
                      • FDA: Prasugrel intuitivepharma 2013-12-24 06:38
                        • FDA: Alternative approaches… Helmut 2013-12-24 14:15
                          • FDA: Alternative approaches… intuitivepharma 2013-12-26 05:11
                            • FDA: RTR Helmut 2013-12-26 14:35
                              • FDA: RTR intuitivepharma 2013-12-31 05:34
                              • FDA: RTR meghalvakil20 2015-07-23 16:32
                                • WayBack Machine Helmut 2015-07-23 16:58
                                  • WayBack Machine meghalvakil20 2015-07-23 17:03
                                    • Old stuff Helmut 2015-07-23 17:28
                • EMA: parent whenever possible ElMaestro 2013-09-20 19:35
                  • EMA: Sirolimus product-specific GL luvblooms 2013-11-19 13:00