Do your homework first [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-07-26 10:42  – Posting: # 20443
Views: 544

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.

Helmut Schütz

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

Complete thread:

 Admin contact
20,140 posts in 4,247 threads, 1,387 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 09:48 CET

The scientific spirit is of more value than its products,
and irrationally held truths may be more harmful
than reasoned errors.    Thomas Henry Huxley

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