Concomitant medications experiment in method validation [Bioanalytics]

posted by Obinoscopy  – USA, 2018-05-02 06:05 (2624 d 14:54 ago) – Posting: # 18745
Views: 5,002

Dear Chandru

❝ We add the concomitant medications to LLOQ of analyte and compare against the calibration standard.


For concomitant medications, you compare the LLOQ (spiked with concomitant medications) with Blank Samples (also spiked with concomitant medications) and calculate the signal to noise ratio (or %interference). Response of interfering peaks at the retention time of the analyte for the blank samples should be less than 20% of the lower limit of quantification for the analyte and 5% for the internal standard.

❝ Any additional experiment has to be performed to evaluate its effect.


Precision and Accuracy needs to be evaluated for the range of CC standards (spiked with the concomitant medications)

Incurred Sample Reanalysis also give an insight on the effect of concomitant medications.

These are my thoughts.

Regards,

Scopy

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,697 registered users;
64 visitors (0 registered, 64 guests [including 16 identified bots]).
Forum time: 21:00 CEST (Europe/Vienna)

Anyone who conducts an argument by appealing to authority
is not using his intelligence;
he is just using his memory.    Leonardo da Vinci

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