Results Analysis [Study As­sess­ment]

posted by unique_one – India, 2014-07-08 10:58 (3604 d 00:15 ago) – Posting: # 13234
Views: 13,727

Dear All,

Results obtained from 2 way-crossover study of 28 volunteers are as mentioned below:

90% CI AUC: Lower limit - 98.35, Upper limit - 132.50
90% CI Cmax: Lower limit - 95.38, Upper limit - 127.80

T/R ratio of AUC: 112.2
T/R ratio of Cmax: 109.5

Intrasubject CV% AUC: 27.3
Intrasubject CV% Cmax: 28.2

Questions:
  1. Primary reason for BE Failure?
  2. Do re-formulation would be needed?
Regards,
unique_one.


Edit: Category changed. [Helmut]

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