Bioequivalence and Bioavailability Forum

Sample size calculation (Pilot study result vs literature) [Power / Sample Size]

posted by Alyssa – Malaysia, 2020-05-04 11:26 (1449 d 23:38 ago) – Posting: # 21392
Views: 8,064

Dear Dr. Dan,

Thanks for your reply.

❝ I guess you are talking about an oral IR formulation, right?

Is a oral MR formulation.

❝ It is reasonable to assume that the ISCV in the pivotal study will be similar to the pilot study if you use the same CRO (study procedure performance), the same test formulation vs. the same (batch of) reference product and the same bioanalytical method.

The CRO we used for pilot study is the same as per the one used in the published literature (sponsor mentioned the CRO name in the PAR). Therefore, the study procedure performance and bioanalytical method variability is reduced.

❝ If costs do not matter you can of course follow the suggestion of the CRO to go for 4 way crossover, replicate design, with ratio 90-111%, ISCV = 35-40%.

Cost is definitely a matter for us now, especially during this Covid-19 pandemic, have to spend wisely. Therefore i need some expert opinion here for my consideration.

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

• Sample size calculation (Pilot study result vs literature) Alyssa 2020-05-04 04:35 
  • Sample size calculation (Pilot study result vs literature) Dr_Dan 2020-05-04 08:46
    • Sample size calculation (Pilot study result vs literature)Alyssa 2020-05-04 09:26
  • Estimation of CVw and/or CVwR Helmut 2020-05-04 12:07
    • Estimation of CVw and/or CVwR ElMaestro 2020-05-04 12:14
      • Mea culpa! Helmut 2020-05-04 12:40
        • It must be Myco ElMaestro 2020-05-04 13:46
          • It is, it is! Helmut 2020-05-04 14:07
            • It is.... Alyssa 2020-05-05 05:00
              • Tutorial Helmut 2020-05-05 12:45
                • Tutorial Alyssa 2020-05-08 06:48
                  • library d_labes 2020-05-08 11:16
                  • Tutorial (from the start) Helmut 2020-05-08 13:08
                    • Tutorial (from the start) Alyssa 2020-05-12 04:05
                      • Tracking down error Helmut 2020-05-12 11:49
                        • Tracking down error: stringsAsFactors d_labes 2020-05-13 11:34
                          • R <4.0.0 Helmut 2020-05-13 12:07
                            • R <4.0.0 ElMaestro 2020-05-13 14:18
                              • R <4.0.0? Helmut 2020-05-13 14:21
                            • PowerTOST’s functions with as.character(design) d_labes 2020-05-13 18:50
                              • PowerTOST’s functions with as.character(design) Helmut 2020-05-13 18:55
                        • Tracking down error Alyssa 2020-05-15 05:08
                          • All’s well that ends well. Helmut 2020-05-15 10:52