Bioanalytical method validation [Bioanalytics]

posted by smrama – India, 2022-05-31 15:41 (250 d 12:47 ago) – Posting: # 23032
Views: 995

Hi all,
This forum has been a good guidance to me, to most of my queries and has been helpful to decide the uncertain situations.

But there is situation which currently I needed some guidance with and below are the details,

In long-term stability experiment, only one out of six LQC was within 85-115%
      % Bias
QC1   +16.99
QC2   +19.44
QC3   -15.59
QC4   -27.04
QC5    +1.21
QC6   +16.90
% CV   19.13
% Bias  1.99


The %CV at LQC was not within 15%. Still, the results were accepted since the % bias was within 15%.

The analytical investigator said that the results can be accepted as per in-house sop, and the “Bioanalytical Method Validation Guidance for Industry” of USFDA and “Guideline on bioanalytical method validation” of EMA if the accuracy (% nominal) at each level be ± 15%.

Please clarify if this approach is acceptable.


Edit: Tabulators changed to spaces and BBcoded; see also this post #6[Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,479 posts in 4,709 threads, 1,603 registered users;
12 visitors (0 registered, 12 guests [including 8 identified bots]).
Forum time: 03:28 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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