RSABE… [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2021-02-24 15:47 (158 d 16:18 ago) – Posting: # 22231
Views: 1,171

Hi Loky do,

» I didn't find this statement in FDA guidance for bioequivalence studies …

RSABE appears in the ANDA draft guidance of December 2013 (footnote 10 on page 4 = page 8 of the PDF).
Don’t waste your money and get the book mentioned there – the chapter is not helpful. Get the paper by Davit et al.* instead. Free and better.

» … just in progesterone guidance so, is it enough to refer to this guide while submitting the st udy to regulatory (as the intrasubject variability CV% equal 57%, partially replicate design), or is there another guide would support this way?

Any one would do, IMHO.



Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 10 (0 registered, 10 guests [including 3 identified bots]).
Forum time: Monday 09:05 CEST (Europe/Vienna)

Imagine if every Thursday your shoes exploded
if you tied them the usual way.
This happens to us all the time with computers,
and nobody thinks of complaining.    Jef Raskin

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