avinash
★    

India,
2014-09-16 15:46
(3481 d 04:36 ago)

Posting: # 13523
Views: 3,818
 

 FDC: Method validation [Bioanalytics]

Dear Members,

With regard to analysis of FDC drugs (Drug A and Drug B). We have two different methods (method A and method B) to analyze the samples, spiked separately.

Since clinical samples contain both the drugs (Drug A and Drug B) and methods are separate for both the drugs spiked individually.

To mimic the clinical sample, we are spiking QCs of drug A in presence of other drug B.

Is it sufficient to do method validation of method A, proving long term stability in presence of other FDC drug and selectivity experiment.

Or

Is it required to do complete method validation in presence of other drug?

Please opine.

Thanks & regards,
Avinash Jain
Ohlbe
★★★

France,
2014-09-17 20:55
(3479 d 23:27 ago)

@ avinash
Posting: # 13529
Views: 3,085
 

 FDC: Method validation

Dear Avinash,

❝ To mimic the clinical sample, we are spiking QCs of drug A in presence of other drug B.


Good precaution.

❝ Is it sufficient to do method validation of method A, proving long term stability in presence of other FDC drug and selectivity experiment.


I would add matrix effects investigations. You can get ion suppression of one drug by the other if they are co-eluted.

❝ Is it required to do complete method validation in presence of other drug?


IMHO no, particularly with co-spiked QCs. One P&A run won't hurt if you want to play it safe.

Regards
Ohlbe
avinash
★    

India,
2014-09-18 07:11
(3479 d 13:11 ago)

@ Ohlbe
Posting: # 13532
Views: 3,022
 

 FDC: Method validation

Dear Ohlbe,

Thanks for the reply.

Avinash
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
83 visitors (0 registered, 83 guests [including 6 identified bots]).
Forum time: 19:22 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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