Bioequivalence and Bioavailability Forum

Incomplete cases [🇷 for BE/BA]

posted by d_labes  – Berlin, Germany, 2008-10-29 10:24 (6019 d 13:23 ago) – Posting: # 2595
Views: 31,367

Dear Yung-yin,

❝ [...] One more question: do we have to include all cases wuth incomplete data (only R or T), or we can treat these cases as dropouts? Which one is more acceptable based on regulatory guidelines (if any)?[...]

By the way: wuth was a brewery in Wiesbaden with good German beer . Nowadays an institute for learning advertising (buy things you do not need), no beer.

But let us be unsmiling scientific:
Generally spoken: Include all data you have.
But in the context of a classical 2x2 design and the use of Proc GLM or equivalent software it does not make a difference with respect to the bioequivalence test (90% confidence interval) as we have seen from our example analysis (3rd analysis) discussed just.

Therefore my attitude up to now was to exclude subjects with incomplete data from a 2x2 cross-over (reporting the data, if any, but not including in the statistical analysis).
But see Helmut's excerpt of SENN here.

In the new EMEA Draft it is stated under 4.1.8 Evaluation/Subject accountability:
"All treated subjects should be included in the statistical analysis, with the exception of subjects in a crossover trial who do not complete at least one period receiving each of the test and reference products (or who fail to complete the single period in a parallel group trial)."

A little bit confusing (at least to me ) but according to Ohlbe it can be interpreted as not to include subjects with data for only one period (... receiving each of the test and reference products ...) from a 2x2 x-over.

Other regulatory recommendations I am not aware in the moment.
Any other out there with a comment?

Complete thread:

• bear v2.0.1 (upwards) cont'd yjlee168 2008-10-26 20:46 [🇷 for BE/BA] 
  • bear v2.0.1 (upwards) cont'd ElMaestro 2008-10-27 20:36
    • bear v2.0.1 (upwards) cont'd yjlee168 2008-10-28 08:59
      • bear v2.0.1 (upwards) cont'd ElMaestro 2008-10-28 09:49
        • Imbalance or incomplete data, SASophylistic view d_labes 2008-10-28 17:14
          • Imbalance or incomplete data, SASophylistic view yjlee168 2008-10-29 07:36
            • Incomplete casesd_labes 2008-10-29 09:24
              • Incomplete cases yjlee168 2008-10-30 07:12
          • Imbalance or incomplete data, SASophylistic view ElMaestro 2008-10-29 09:27
            • Gold in discussion d_labes 2008-10-29 09:56
              • Gold? Helmut 2008-10-29 13:03
          • Imbalance or incomplete data, WinNonlin5.2.1 Helmut 2008-10-29 12:12
            • Incomplete data, SAS9.2 d_labes 2008-10-29 16:38
              • Missing values, imputation; separate study ElMaestro 2008-10-30 08:57
              • Incomplete data, SAS9.2, DDF option residual d_labes 2008-10-30 15:54
                • Never belief in any software you haven't written yourself Helmut 2008-10-30 16:30
          • Imbalance or incomplete data, SASophylistic view yjlee168 2008-11-07 05:12
            • Imbalance or incomplete data, SASophylistic view d_labes 2008-11-11 08:35
              • Imbalance or incomplete data, SASophylistic view yjlee168 2008-11-11 08:54
                • Imbalance or incomplete data, SASophylistic view d_labes 2008-11-11 13:13
                  • Imbalance or incomplete data, SASophylistic view yjlee168 2008-11-11 13:35
                    • Imbalance or incomplete data, SASophylistic view d_labes 2008-11-11 14:02
              • Notification about new posts Helmut 2008-11-11 12:24
                • Notification about new posts d_labes 2008-11-11 13:24
                  • 3 Prerequisites for biostatistics Helmut 2008-11-11 13:39
                    • 3 Prerequisites for biostatistics d_labes 2008-11-11 14:09