Dear Members:
I invite you to attend our community June 13th webinar by Professor Joga Gobburu. I am sure we all will be benefited from his knowledge and unique program developed by the team of scientists he mentored.
Title: How Model-Informed BE Trials in Pumas Software Cut-down your trial by 50%? - Professor Joga Gobburu, UMBC
Date and Time: June 13, 2022 9.00 -10.30 am (EST)
Please join my meeting from your computer, tablet or smartphone.
https://meet.goto.com/455974701
Abstract: Establishing BE of complex dosage forms require larger and longer trials. This affects both the brand and generic companies alike. In some cases, the BE trials end up larger than the efficacy/safety trials themselves. Additionally, such trials are challenging to conduct. To address challenges in complex dosage drug development, we can apply the "learn-apply paradigm". The learn-apply paradigm involves three steps. First, we perform an abbreviated BE study (ABE), a shorter, single-dose BE study with fewer subjects. Second, we perform a model-based analysis of the ABE to learn from the ABE. Third, we apply the model and parameters derived from the ABE to simulate a full BE study (FBE) with more subjects and full sampling. We showed that a model-integrated FBE study can preserve Type 1 error and have high power. The modeling and simulation exercise will be demonstrated using Pumas software, which is developed for such advanced tasks.
Biosketch: Dr. Gobburu is Professor with the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore, MD, USA. He held various positions at the US FDA between 1998 and 2011. He has experience with overseeing the review of 1000s of Investigational New Drug Applications (INDs), over 250 New Drug and Biological Licensing Applications, numerous FDA Guidances and policies pertaining to drug approval and labeling. At the FDA, he was part of the committee responsible for 21st Review Process and provided input into PDUFA planning. He received numerous FDA awards such as the Outstanding Achievement Award and recognized with the Senior Biomedical Research Scientist appointment. He also received the Outstanding Leadership Award from the American Conference on Pharmacometrics (2008), the Tanabe's Young Investigator Award from the American College of Clinical Pharmacology (2008) and Sheiner-Beal Pharmacometrics Award from the American Society of Clinical Pharmacology and Therapeutics (2019). He is also a Fellow of AAPS and ACCP. Dr. Gobburu is on the Editorial Boards of several journals. He has published over 100 papers and book chapters.
Contact Details
BEBAS June 13 2022 Webinar Professor Joga GobburuThu, Jun 2, 2022 9:00 PM - 10:00 PM (EDT)Please join my meeting from your computer, tablet or smartphone.https://meet.goto.com/455974701You can also dial in using your phone.United States: +1 (224) 501-3412Access Code: 455-974-701Join from a video-conferencing room or system.Dial in or type: 67.217.95.2 or inroomlink.goto.comMeeting ID: 455 974 701Or dial directly: [email protected] or 67.217.95.2##455974701------------------------------
Prasad Tata M. Pharm, Ph.D., FCP
Clinical Development
Sandoz, Inc.
Princeton NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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