FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by Yura – Belarus, 2018-05-25 10:22 (1241 d 17:12 ago) – Posting: # 18815
Views: 1,865

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
21,731 posts in 4,544 threads, 1,543 registered users;
online 7 (0 registered, 7 guests [including 1 identified bots]).
Forum time: Monday 03:34 CEST (Europe/Vienna)

Law is mind without reason.    Aristotle

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