Results Analysis [Study As­sess­ment]

posted by unique_one – India, 2014-07-08 10:58 (3959 d 01:05 ago) – Posting: # 13234
Views: 18,324

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,669 registered users;
84 visitors (0 registered, 84 guests [including 6 identified bots]).
Forum time: 12:03 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us.    Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5