Method Validation [Bioanalytics]

posted by chiragkhatri – India, 2007-12-14 07:21 (6765 d 22:38 ago) – Posting: # 1374
Views: 6,684

Dear members,

I have a combination of Drug 1+2+3. Since it is not possible to analyze all three together, I have validated method for drug 1 separately and drug 2and 3 will be validated in combination.

The point here is since subject samples will be in combination of all three, I will be analyzing it twice with two different methods, but the validation is not done in presence of drug1 for drug2 and drug3 and vice versa.

I nedd suggestions as to how to plan an experiment so that it can be proved that the method used for Drug1 does not have any interference of drug 2 and drug3 and vice-versa.

Any reference to guidelines are welcome.

Thanks in advance

Chirag Khatri

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
126 visitors (0 registered, 126 guests [including 14 identified bots]).
Forum time: 06:59 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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