Change in curve changed the ratio of Cmax [Bioanalytics]

posted by Compliance – India, 2015-03-23 10:27 (3716 d 18:31 ago) – Posting: # 14593
Views: 12,408

❝ You analysed the same samples with two different (fully validated?) methods and got two different results.


Yes we have full validated method.

❝ This is not correct. If the change affected all samples you would have no difference in study results.


please note the difference is throughout the study irrespective of test and reference.
In this case i give you one example during initial study analysis one of the subject has only three period quantify and rest of the period has zero or BL Q concentration. After repeat study with the lower LLOQ, the obtain concentration is around 0.23 ng in one period and 23 ng/ml in other period of test.

Now during point estimation such difference will impact the result and there are few such kind of subjects which are gets qualify after having analysis under lower curve.

Please consider above situation.

Regards,

Compliance

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
24 visitors (0 registered, 24 guests [including 8 identified bots]).
Forum time: 05:59 CEST (Europe/Vienna)

Far better an approximate answer to the right question,
which is often vague, than an exact answer to the wrong question,
which can always be made precise.    John W. Tukey

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