Author: [AUTHOR] Published on 5/6/2019 7:13:00 AM ASCPT Members-Only Webinar presented by the Early Development & Drug Safety Community
Title: First-in-Human Starting Dose Selection: Learnings from Survey by IQ MABEL Working Group and Experiences of the Regulatory Agency
Date and Time: Wednesday, May 22, 2019, 12:00 pm ET
Speaker: Haw-Jyh (Brian) Chiu, PhD
Moderator: Chao Han, MSc, PhD
Description: The importance of selecting a proper first-in-human (FIH) starting dose has been increasingly comprehended by the pharmaceutical industry and regulatory agency since the TeGenero incidence in 2006. The minimum anticipated biological effect level (MABEL) approach was proposed by the EMEA in 2007. Ten years later, an IQ Working Group conducted a cross-industry survey about the practice and performance of using MABEL. The results will be shared during this special presentation along with the observations and recommendations made by the working group. The Office of Hematology and Oncology Product at the US FDA has retrospectively analyzed preclinical data and approaches used for FIH starting dose selection. The experiences will be presented with some insightful discussions for assessing and establishing more efficient approaches for FIH dose selection.
Registration Link: https://attendee.gotowebinar.com/register/3154649891752265987
