Two tests, one ref, replicate for ref for possiblescaling. [Design Issues]

posted by ElMaestro  – Denmark, 2013-04-05 19:37 (4826 d 07:03 ago) – Posting: # 10358
Views: 7,851

Hello Ken,

❝ We can run a 3-way crossover study comparing a test product in different dosage forms (capsule and tablet) and a reference product.


❝ For highly variable drug, we need to carry out replicate design, either partial or full replicate. How to fit one reference product and one test product in different dosage forms into replicate design ? Any idea ? :confused:


If I get you right, then Test(Caps)-Test(Tabs)-Ref-Ref and (a subset of) permutations thereof will work.

Provided that I haven't misunderstood the latest trends in sequence coding defined by possible descendants of Ötzi this is equivalent (no pun intended) to Hocus(Caps)-Hocus(Tabs)-Pocus-Pocus or something like that plus permutations.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
132 visitors (0 registered, 132 guests [including 49 identified bots]).
Forum time: 02:41 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

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