Method validation for each species [Bioanalytics]

posted by janmacek – Czech Republic, 2016-05-11 15:09 (3203 d 05:10 ago) – Posting: # 16293
Views: 2,435

Dear all,

we are planning validation of a bioanalytical method for the determination of a drug candidate in plasma. This method should be used for the analysis of samples from various species (rat, mouse, dog, etc.). The European Guideline states that full validation should be performed for each species and matrix concerned, while the FDA guideline states that partial validation is required for the change of species within matrix.

What is your experience with this topic? Is the approach really different in Europe and US?

With best regards,

Jan

Complete thread:

UA Flag
Activity
 Admin contact
23,381 posts in 4,914 threads, 1,663 registered users;
51 visitors (0 registered, 51 guests [including 9 identified bots]).
Forum time: 19:19 CET (Europe/Vienna)

Science is built up with facts, as a house is with stones.
But a collection of facts is no more a science
than a heap of stones is a house.    Henri Poincaré

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