Freshly spiked calibration standard in validation [Bioanalytics]

posted by chandru – India, 2018-02-14 06:28  – Posting: # 18415
Views: 1,464

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
19,604 posts in 4,158 threads, 1,340 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 17:11 CEST

Nothing in the world is more dangerous
than sincere ignorance
and conscientious stupidity.    Martin Luther King, Jr.

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