Concomitant medications experiment in method validation [Bioanalytics]

posted by ElMaestro  – Denmark, 2018-05-02 09:25 (1560 d 13:04 ago) – Posting: # 18746
Views: 3,207

Hi chandru,

» How to evaluate the effect of concomitant medications during validation?

Wow, that is actually a great question, and a controversial one.

Some CROs believe that when they do LC-MS/MS they don't have to evaluate it. Interference is impossible, there would never be an interfering transition, testing for it is a waste of time, inteference like ion enhancement has never been seen, and some singing and dancing to that tune.

The better CROs, and here better is in this regard a purely subjective term reflecting just my personal opinion, will test A+P by spiking the QCs at roughly Cmax levels they get from the literature (incl. prescribing info, SPCs, PARs) along with a check of interference on blanks. Some will do the spiking experiment individually, and some will do it with a cocktail. Both approaches seem to be widely accepted by agencies.
It is furthermore becoming a proper practice to have an SOP in place so that the lab is informed of any concomitant meds that are given, and if a drug has been given which wasn't part of the validation, then there will be an adhoc interference experiment for that drug (non-cocktail type).

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,289 posts in 4,666 threads, 1,585 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Tuesday 22:30 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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