Scaling (EU) [Surveys]

posted by Helmut Homepage – Vienna, Austria, 2010-12-14 13:33 (5659 d 01:12 ago) – Posting: # 6300
Views: 6,987

Dear all,

have you performed a BE-study with scaling for Cmax already?

If yes, which statistical code have you used?
  1. FDA's (2001) for IBE/PBE to calculate sigmaWR; ABEL according to EMA (2010).
  2. FDA's (2010) => ABEL.
  3. Other (= what a question; I always write my own stuff!)
If no, why not?
  1. I'm still confused and waiting until my CRO(s) get a better understanding.
  2. I'm waiting for EMA's code.
  3. I want to avoid discussions and stick to 80%-125%.
  4. What the h... are you talking about?

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
23,653 posts in 4,991 threads, 1,571 registered users;
156 visitors (0 registered, 156 guests [including 17 identified bots]).
Forum time: 15:45 CEST (Europe/Vienna)

Outside his own ever-narrowing field of specialization,
a scientist is a layman.
What members of an academy of science have in common
is a certain form of semiparasitic living.    Erwin Chargaff

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