Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-23 17:24 CEST (UTC+2h)
chandru
Junior

India,
2018-02-14 06:28

Posting: # 18415
Views: 960
 

 Freshly spiked calibration standard in validation [Bioanalytics]

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
Obinoscopy
Junior

Nigeria,
2018-05-02 12:45

@ chandru
Posting: # 18750
Views: 335
 

 Freshly spiked calibration standard in validation

Hi,

» 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?

Yes you can, as long as you demonstrated the long term matrix stability of your analyte.

But the critical question is this: which CC did you use in demonstrating long term stability? Was the curve gotten from freshly prepared calibration standards? This is because only CCs from freshly prepared standards are to be used for stability determination.

Regards,

Scopy
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,190 registered users;
online 16 (1 registered, 15 guests [including 13 identified bots]).

[The] impatience with ambiguity can be criticized in the phrase:
absence of evidence is not evidence of absence.    Carl Sagan

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