avinash
★    

India,
2022-07-06 07:04
(40 d 01:24 ago)

Posting: # 23108
Views: 322
 

 Evaluation of Matrix effect [Bioanalytics]

Dear Members

This is with regard to ICH M10 guideline

For Matrix effect, it is mentioned as “should be evaluated by analysing at least 3 replicates of low and high QCs, each prepared using matrix from at least 6 different sources/lots. For each individual matrix sources/lots evaluated, the accuracy should be within ±15% of the nominal concentration and the precision (per cent coefficient of variation (%CV)) should not be greater than 15%”

To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment?

Matrix factor, Our practice is to compare post extracted spiked sample vs aqueous sample, acceptance criteria is CV for matrix factor and IS normalised matrix factor should be ≤ 15%

Please opine.

Thanks & regards,
Avinash


Edit: category changed [Ohlbe]
Ohlbe
★★★

France,
2022-07-06 10:18
(39 d 22:10 ago)

@ avinash
Posting: # 23109
Views: 273
 

 Evaluation of Matrix effect

Dear Avinash,

» For each individual matrix sources/lots evaluated, the accuracy should be within ±15% of the nominal concentration and the precision (per cent coefficient of variation (%CV)) should not be greater than 15%”
»
» To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment?

Well, how else could you check accuracy ? But of course: the blank matrix used to prepare calibration samples should not be one of the matrices tested for matrix effects, otherwise this would bias the experiment (you'd be sure that at least this one would pass).

» Matrix factor, Our practice is to compare post extracted spiked sample vs aqueous sample, acceptance criteria is CV for matrix factor and IS normalised matrix factor should be ≤ 15%

Yes, that's what was in the EMA guideline, based on the recommendations of the Crystal City III conference in 2006. Recommendations in M10 are now different and you'll have to update your SOP and change your practice.

Regards
Ohlbe
avinash
★    

India,
2022-07-06 10:35
(39 d 21:53 ago)

@ Ohlbe
Posting: # 23110
Views: 269
 

 Evaluation of Matrix effect

Dear Ohlbe

Thank you.

Regards,
Avinash
UA Flag
Activity
 Admin contact
22,301 posts in 4,667 threads, 1,585 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Monday 08:28 CEST (Europe/Vienna)

Science… never solves a problem
without creating ten more.    George Bernard Shaw

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