Evaluation of Reference variability [Design Issues]

posted by Nirali  – India, 2009-04-13 11:53  – Posting: # 3515
Views: 2,750

Dear All,

We want to conduct BE replicate study to demonstrate that the within-subject variability for Cmax of the reference compound in the study is >30% for EU regulatory.

To check reference variablity which study design and model shall be used for statistical analysis?

Shall we use 2-period replicate design to assess the inter and intra-subject variability of reference drug, in which reference drug given in both the periods?

Thanks & Regards,
NIRALI

Complete thread:

Activity
 Admin contact
20,346 posts in 4,274 threads, 1,404 registered users;
online 15 (0 registered, 15 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 09:42 CET

The belief that there is only one truth and
that oneself is in possession of it,
seems to me the deepest root of all
that is evil in the world.    Max Born

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