FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by Yura – Belarus, 2018-05-25 10:22 (1342 d 12:22 ago) – Posting: # 18815
Views: 1,892

Hi John,
The biowaiver for lower dosages (T1, T2) is administered with the dosage (T), which participated in the bioequivalent study.
with respect

Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 11 (0 registered, 11 guests [including 9 identified bots]).
Forum time: Wednesday 21:44 CET (Europe/Vienna)

The real purpose of the scientific method is to make sure
nature hasn’t misled you into thinking you know something
you actually don’t know.    Robert M. Pirsig

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