Bioanalytical method validation [Bioanalytics]

posted by smrama – India, 2022-05-31 15:41 (186 d 16:37 ago) – Posting: # 23032
Views: 870

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
22,427 posts in 4,694 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 8 identified bots]).
Forum time: 07:18 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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