Parent Drug and Active Metabolite (FDA) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2006-05-10 10:22 (6533 d 01:14 ago) – Posting: # 123
Views: 7,989

❝ […] would this mean that ANOVA on the metabolite data is not necessary?


Hi Joy,

yes, IMHO no confidence interval of the metabolite; you should present just means, standard deviations, etc. If you opt to present a confidence interval make clear in the protocol, that there's no acceptance range for it.

The wonderful thing about FDA is that you have to present the study protocol to them anyhow; if they don't like it, they will tell you ;-)

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
22,957 posts in 4,819 threads, 1,636 registered users;
109 visitors (0 registered, 109 guests [including 6 identified bots]).
Forum time: 10:37 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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