Do your homework first [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-07-26 10:42 (460 d 19:57 ago) – Posting: # 20443
Views: 1,293

Hi Neil,

do you see Guidelines on top of the page?

What about the overarching “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA”? If in doubt, initiate a Controlled Correspondence. Otherwise, you risk an R-t-R.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,477 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Thursday 05:39 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