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

posted by Ravuri sindhura – India, 2019-09-18 21:16 (2113 d 15:54 ago) – Posting: # 20614
Views: 11,566

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:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,679 registered users;
34 visitors (0 registered, 34 guests [including 9 identified bots]).
Forum time: 13:11 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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