Bioequivalence and Bioavailability Forum 07:01 CEST

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: 1,015

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,622 posts in 3,967 threads, 1,210 registered users;
online 24 (1 registered, 23 guests [including 17 identified bots]).

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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