Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-11 12:19 CET (UTC+1h)
 

Justification for the lack of incurred sample reanalysis [Regulatives / Guidelines]

posted by irene - Greece, 2017-02-13 07:58  - Posting: # 17053
Views: 1,333

Hello,

in the EMA's "Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP)" it states the lack of incurred sample reanalysis data for a bioequivalence study can be justified. One of the points that should be adreessed is
I would like to ask if someone has ever provided these data and how the probability of a false positive outcome can be calculated. I was thinking of using simulations but it is not clear which parameters should I vary and which distributions to use (i.e. mean and sd).

Thank you in advance,

Irene

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,549 Posts in 3,756 Threads, 1,090 registered users;
39 users online (1 registered, 38 guests).

To know much is often the cause of doubting more.    Michel de Montaigne

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed