Crossover: samples of p1 and p2 in different batches? [Bioanalytics]

posted by Ravuri sindhura – India, 2019-09-18 17:16  – Posting: # 20614
Views: 1,557

As per FDA Bioanalytical method validation Guidance for Industry "All study samples from subject should be analysed in a single run, especially for studies designed with repeated measures from individual subjects(eg; crossover or sequential design required for BE studies)".
Can the study samples of same subject in more than single run for cross over design can be analysed i'e analysis of P1 samples and P2 samples can be carried out separately in two different runs? If yes, how it need to be justify to regulatory?


Edit: Category and subject line changed; see also this post #1, #2. Please follow the Forum’s Policy[Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
20,037 posts in 4,233 threads, 1,378 registered users;
online 5 (2 registered, 3 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 13:49 UTC

Maturity is the capacity to endure uncertainty.    John Finley

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5