505 b(2) application & requirement of bioequivalence [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2023-05-05 15:38 (406 d 01:36 ago) – Posting: # 23545
Views: 1,510

Hello Mithu!

As we rely on existing PKPD relationship, toxicity data and other pharmacology data of reference drug, the BE is required.

Regards,
Divyen

Complete thread:

UA Flag
Activity
 Admin contact
23,056 posts in 4,840 threads, 1,641 registered users;
147 visitors (0 registered, 147 guests [including 76 identified bots]).
Forum time: 17:15 CEST (Europe/Vienna)

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

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