Bioequivalence and Bioavailability Forum

Metadate CD sampling: 24 hours [Design Issues]

posted by jag009  – NJ, 2012-04-13 17:59 (5182 d 01:05 ago) – Posting: # 8420
Views: 4,951

Hi Helmut,

It's Friday!

❝ I don’t have the slightest idea why some people^* performed studies of a drug with so little intra-subject variability in 36 subjects (even CV of AUC_0-4 was only 13.5%).

❝ Power for CV 15% and T/R 95% is 83% in just 12 subjects.

I guess it's a comfort factor for them in case something does happen during the study and more than half the subjects went wazoo (food poisoning or others..). We need at least n=12 to submit... I ran a study in my previous company with 36 subjects and 18 subjects were removed from the study due to food poisoning in the clinic (post dose, not sure if it was really food poisoning since the other subjects were fine). We ended up submitting the study results with 17 subjects (1 quit)...

Complete thread:

• Metadate CD sampling jag009 2012-04-12 18:11 
  • Metadate CD sampling: 24 hours Helmut 2012-04-12 18:45
    • Metadate CD sampling: 24 hours jag009 2012-04-12 23:44
      • Metadate CD sampling: 24 hours Helmut 2012-04-13 00:43
        • Metadate CD sampling: 24 hoursjag009 2012-04-13 15:59
          • power… Helmut 2012-04-13 16:17
          • Sounds fine ElMaestro 2012-04-13 16:35
        • Metadate CD sampling: 24 hours jag009 2012-04-18 15:57
          • Metadate CD sampling: 24 hours ElMaestro 2012-04-18 16:35
            • Metadate CD sampling: 24 hours jag009 2012-04-18 17:09