Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence [BE/BA News]

posted by SMA – Europe, 2023-02-06 10:07 (496 d 19:53 ago) – Posting: # 23439
Views: 4,559

Good morning all

FDA is organizing a webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Agenda

March 14, 2023
10:00 AM - 12:00 PM US ET

TOPICS COVERED
In Vitro Bioequivalence assessment
Statistical Methods for Narrow Therapeutic Index and Highly Variable Drug Products
Comparative Clinical Endpoint Bioequivalence Studies
Studies in Multiple Groups
Bioequivalence Statistics for Adhesion and Irritation Studies
Dose Scale for Bioequivalence Assessment

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