least common multiple of T and R [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-05-24 14:32 (625 d 19:55 ago) – Posting: # 22364
Views: 1,381

Hi Vishal,

❝ How to prove the bioequivalence if test formulation having strength 325 mg and reference formulation having strength 500 mg


When administering single doses, such a large dose-correction will not be acceptable (see there). I did it once 20 years ago when strict dose-proportionality was known for R and proven for T in another study. It was accepted by the German BfArM but we were told at the same time “Please do that never again.”

You would need to administer the least common multiple of the strengths (6,500 mg), i.e., 20 units of T and 13 units of R. This will be difficult even if this single dose is within the approved range.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,488 posts in 4,711 threads, 1,605 registered users;
18 visitors (0 registered, 18 guests [including 4 identified bots]).
Forum time: 09:27 CET (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

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