Bioequivalence and Bioavailability Forum 04:20 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Freshly spiked calibration standard in validation [Bioanalytics]

posted by chandru - India, 2018-02-14 06:28  - Posting: # 18415
Views: 1,315

Hi all,
According to EMA "Calibration standards shall preferably be prepared using freshly spiked samples, it is allowed to use previously prepared and stored calibration samples, if supported by appropriate stability data."

So shall we use stored calibration standards for evaluation of PA during validation, if we prove Long term matrix stability at the end of validation?

Regards,
Chandru

Thanks in advance

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,154 posts in 4,080 threads, 1,308 registered users;
online 16 (0 registered, 16 guests [including 4 identified bots]).

One can show the following: given any rule, however “fundamental”
or “necessary” for science, there are always circumstances
when it is advisable not only to ignore the rule,
but to adopt its opposite.    Paul Feyerabend

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed