Bioequivalence and Bioavailability Forum

CVintra # CVinter # CVtotal [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2008-11-20 12:18 (6414 d 08:05 ago) – Posting: # 2747
Views: 9,267

Dear Muneesh,

❝ I donot understand what do you mean by replicated dosing in the parallel arms to get the CV.

If you want to plan the sample size for a cross-over study you need the intra-subject variability (CV_intra). If you have dosed both treatments only once per subject (nonreplicate) in a parallel design, you only have the total variability (CV_total). See this post (you may have found it searching the forum as DLabes suggested already).

❝ And in another pilot study with parallel design for long half-life drug, subjects were dosed only once in the study.

OK, you are talking about the same drug hopefully? You have one cross-over pilot and one parallel and now want to plan a pivotal cross-over? From the cross-over study you may get a relationship of CV_intra and CV_total, which you may apply to the parallel getting another estimate of CVi_ntra. You may pool these two CV_intra-values - but this is some kind of vicious circle…

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


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Complete thread:

• sample size for BA/BE studies drmuneesh 2008-10-18 09:17 [Regulatives / Guidelines] 
  • sample size for BA/BE studies shankar 2008-10-18 11:47
    • sample size for BA/BE studies drmuneesh 2008-10-18 12:18
      • sample size for BA/BE studies Ohlbe 2008-10-18 13:32
        • sample size for BA/BE studies drmuneesh 2008-10-19 10:42
        • sample size for BA/BE studies drmuneesh 2008-11-17 14:10
          • sample size for BA/BE studies ElMaestro 2008-11-17 14:32
            • sample size for BA/BE studies drmuneesh 2008-11-18 10:34
            • sample size for BA/BE studies drmuneesh 2008-11-28 07:50
          • sample size for BA/BE studies Helmut 2008-11-17 15:47
            • sample size for BA/BE studies drmuneesh 2008-11-18 07:44
              • sample size for BA/BE studies ElMaestro 2008-11-18 08:49
                • sample size for BA/BE studies drmuneesh 2008-11-18 09:31
                  • sample size for BA/BE studies ElMaestro 2008-11-18 09:59
                    • sample size for BA/BE studies drmuneesh 2008-11-18 10:27
                      • sample size for BA/BE studies drmuneesh 2008-11-19 10:14
                        • sample size for BA/BE studies ElMaestro 2008-11-19 10:48
                          • sample size for BA/BE studies drmuneesh 2008-11-20 08:30
                            • CVintra # CVinter # CVtotalHelmut 2008-11-20 11:18
                              • Circulus vitiosus d_labes 2008-11-20 13:57
                                • Sterne! Helmut 2008-11-20 18:11
                              • CVintra # CVinter # CVtotal drmuneesh 2008-11-28 10:37
                                • CVintra # CVinter # CVtotal Helmut 2008-11-29 10:14
                                  • CVintra # CVinter # CVtotal drmuneesh 2008-11-30 07:18
                                • is something fishy in case 2? ElMaestro 2008-11-29 15:42
                                  • is something fishy in case 2? drmuneesh 2008-11-30 07:17
                        • SAS and sample size d_labes 2008-11-19 11:33
                          • SAS and sample size drmuneesh 2008-11-20 08:31