Bioequivalence and Bioavailability Forum

2-Study Meta-analysis [General Sta­tis­tics]

posted by d_labes  – Berlin, Germany, 2010-04-12 17:03 (5915 d 07:22 ago) – Posting: # 5091
Views: 10,433

Dear Helmut!

❝ Interesting Section II.1.3:

❝ A retrospective meta-analysis of only two studies originally intended to stand on their own is not expected to add any useful information. In parti­cu­lar, a meta-analysis cannot be used to reconcile the conflicting results of one positive and one inconclusive study.

THX for highlighting this. IMHO its not so very sound, not to say ... urrgh (cervix blocked to to keep a civil tongue ), especially if the study sizes differ to a greater extent.

Fortunately this is weaker formulated in the new BE guidance, text pointed to by earlybird, page 16: "Alternatively, when relevant, a combined analysis of all studies can be provided in addition to the individual study analyses. It is not acceptable to pool together studies which fail to demonstrate bioequivalence in the absence of a study that does."
Hopefully this overrules.

Complete thread:

• Meta-analysis earlybird 2010-04-09 07:54 
  • Meta-analysis in SAS d_labes 2010-04-09 08:35
    • Meta-analysis vs. naïve pooling Helmut 2010-04-09 20:33
      • Meta-analysis vs. naïve pooling ElMaestro 2010-04-09 22:02
        • Meta-analysis vs. naïve pooling Helmut 2010-04-09 22:11
          • Meta-analysis vs. naïve pooling ElMaestro 2010-04-09 22:20
            • Meta-analysis vs. naïve pooling Helmut 2010-04-10 00:49
              • Meta-analysis vs. naïve pooling ElMaestro 2010-04-10 08:13
                • Yes, but... Helmut 2010-04-10 14:46
                  • Yes, but... ElMaestro 2010-04-11 11:44
                    • Yes, but... Helmut 2010-04-11 14:27
      • Meta-analysis alpha d_labes 2010-04-12 13:32
        • Meta-analysis alpha Helmut 2010-04-12 14:25
          • 2-Study Meta-analysisd_labes 2010-04-12 15:03
            • 2-Study Meta-analysis Helmut 2010-04-12 15:18
              • Anatomical miracle d_labes 2010-04-12 15:33
                • Anatomical miracle Helmut 2010-04-12 15:40