Keynote: Applications of MIDD for Dose Selection, Specific Populations, and Beyond: The Advantages of Bracketing

Tuesday, October 18, 2022

1:30 PM – 2:30 PM ET

Location:151 AB

Keynote Speaker(s)

Julie Bullock, PharmD

Global Head of Clinical Pharmacology & Translational Medicine
Certara
Raleigh, North Carolina

Moderator(s)

Vaishali Sahasrabudhe, PhD (she/her/hers)

Clinical Pharmacology Therapeutic Area Head for Internal Medicine
Pfizer Inc.
Groton, Connecticut

Bracketing is an often overlooked approach to not only justify a dose regimen, but to also put into context exposure differences for specific populations and extrinsic factors. Case studies of MIDD approaches and how they can be applied to these scenarios will be discussed and the benefits of bracketing to the overall development program both pre and post approval will be outlined.

Learning Objectives:

understand the meaning and application of bracketing in drug development
knowledge of the MIDD approaches used for dose selection, specifc populations and bracketing approaches
acknolwedge the data requirements to successfully leverage MIDD and bracketing approaches