Bioequivalence and Bioavailability Forum

What's the problem? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2017-07-11 16:56 (2811 d 23:14 ago) – Posting: # 17534
Views: 22,093

❝ Recently we did pilot and pivotal (Partial reference replicate) studies for WHO and we got high variability (CV=32%). In the USFDA product specific guidance they have suggested 2x2 crossover design for this drug. Based on our prior experience can we perform reference replicate study or need to go as per guidance?

You probably have both options available. However, the gain with CV=32% is minute; I mean if you have a CVr of 32% in a replicate study you are widening the limits so minutely that I think it isn't worth the effort. At the end of the day those (semi)replicated are still far less routine than the standard 222BE jobs. And IEC's can have a lot of funny ideas when they review your protocol etc.

That said, I'd like to know the background better before saying this is my final answer

Complete thread:

• Highly Variable Drug BE Justification jag009 2017-03-20 04:42 [Regulatives / Guidelines] 
  • Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
    • Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
      • Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
        • Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
          • Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
            • expected power d_labes 2017-03-21 15:16
            • Doesn't hurt! VStus 2017-03-23 14:24
      • Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
      • Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
        • Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
          • Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
            • Applicability of reference-scaling Helmut 2017-05-10 14:10
          • Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
            • Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
              • Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
              • Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
                • Regulators view of HVD drugs Helmut 2017-05-16 15:01
                • What's the problem? ElMaestro 2017-05-17 03:30
                  • What's the problem? nobody 2017-05-17 07:48
                    • What's the problem? nobody 2017-05-17 09:31
                      • What's the problem? DavidManteigas 2017-05-17 11:25
                        • What's the problem? ElMaestro 2017-05-17 12:07
                          • What's the problem? kumarnaidu 2017-07-11 14:43
                            • What's the problem?ElMaestro 2017-07-11 14:56