Bioequivalence and Bioavailability Forum 00:01 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Multiple dose study for MR product in EU [Regulatives / Guidelines]

posted by Mahesh M - India, 2014-09-26 11:53  - Posting: # 13591
Views: 2,872

Dear All,

When multiple dose study is required To demonstration of Bioequivalence between two MR dosage form for EU.
The European guidance line no. 593 to 595 states as follows:

"A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".

Please elaborate or simplify the same for better understanding.

Regards

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,923 posts in 4,039 threads, 1,284 registered users;
online 12 (0 registered, 12 guests [including 9 identified bots]).

If you think it’s simple,
then you have misunderstood the problem.    Bjarne Stroustrup

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