Bioequivalence and Bioavailability Forum

Uncertainty of CVs; AUC72 - actual vs. nominal time [Power / Sample Size]

posted by jag009  – NJ, 2012-05-11 20:13 (4736 d 02:37 ago) – Posting: # 8563
Views: 5,640

❝ You are aware that you may loose power according to this procedure? What if the CRO want’s to make money (they all do)¹ and tell the subjects.

Well I don't forsee that big of a problem and I think 1 hour is more than reasonable. I haven't seen a study so far which has subjects with a > 1 hr deviation on sample collection time.

Cost will be the problem if we have to house the subject for 72 hours. I need to run fast and fed studies (for 2 strengths, not proportional).. I agree that we can go down on sample size to compensate...

❝ 1. “We are really terribly sorry that the study did not pass due to so many excluded subjects. Do you want to repeat it in a larger sample size?”

❝ 2. Flimsy excuse. Public transportation is a nightmare everywhere in the US, IMHO.

More like tough luck, that is the client's problem so just pay us and we wil rerun the study. Hey I am runnig with 48 subjects! BTW, not running in US though.

Yes it's Friday!

Complete thread:

• Sample Size from Interaction study jag009 2012-05-10 16:14 
  • Sample Size from Interaction study Helmut 2012-05-10 16:42
    • Sample Size from Interaction study jag009 2012-05-10 19:39
      • Uncertainty of CVs; AUC72 - actual vs. nominal time Helmut 2012-05-11 15:13
        • Uncertainty of CVs; AUC72 - actual vs. nominal time jag009 2012-05-11 16:36
          • Uncertainty of CVs; AUC72 - actual vs. nominal time Helmut 2012-05-11 17:35
            • Uncertainty of CVs; AUC72 - actual vs. nominal timejag009 2012-05-11 18:13