avinash
☆    

India,
2018-11-13 12:30

Posting: # 19595
Views: 1,928
 

 Selectivity [Bioanalytics]

Dear Members,

In Bioanalytical Method Validation - Guidance for Industry - May 2018, For Selectivity parameter one of the acceptance criteria is mentioned as “Blank and zero calibrators should be free of interference at the retention times of the analyte(s) and the IS”.

Which means? Should we run Selectivity samples with calibrators?

Practice is after Specificity and Selectivity, pooling of matrix lots and spiking of calibrators and quality control samples.

Please opine.

Thanks & regards,
Avinash Jain M V


Edit: Category changed; see also this post #1[Helmut]
Ohlbe
★★★

France,
2018-11-13 13:56

@ avinash
Posting: # 19596
Views: 1,660
 

 Selectivity

Dear Avinash,

» Which means? Should we run Selectivity samples with calibrators?

Not necessarily a full calibration curve, but at least samples spiked at the LLOQ, so that you can compare the signal in the blanks to the signal at the LLOQ.

Regards
Ohlbe
avinash
☆    

India,
2018-11-14 04:35

@ Ohlbe
Posting: # 19599
Views: 1,626
 

 Selectivity

Dear Ohlbe,

Thank you for the response.

Regards,
Avinash
chandru
☆    

India,
2019-01-01 12:16

@ Ohlbe
Posting: # 19720
Views: 1,275
 

 Selectivity

Dear Ohlbe,

» Not necessarily a full calibration curve, but at least samples spiked at the LLOQ, so that you can compare the signal in the blanks to the signal at the LLOQ.

For Selectivity experiment whether only 8 blanks and 8 LLOQ is sufficient.

Because even in our company we have changed the procedure of performing Selectivity by running this samples against freshly spiked Calibration and quality control samples.

Regards

Chandru
Activity
 Admin contact
20,642 posts in 4,327 threads, 1,436 registered users;
online 10 (1 registered, 9 guests [including 4 identified bots]).
Forum time: 21:52 CEST (Europe/Vienna)

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauß

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