Model-Informed Drug Development in the Age of AI
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CertaraMarch 10, 2025
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach
This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…
CertaraMarch 4, 2025
How the US FDA MIDD paired pilot program helps sponsors
February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…
CertaraFebruary 28, 2025
Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe
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CertaraFebruary 28, 2025
PBBM Educational Webinar Series (Part 1): The Basics of Drug Absorption in Drug Development – Why is Drug Absorption Essential? [Japanese Webinar]
Part 2 on July 17th : What is the Drug Absorption Model? Part 3 in…
CertaraFebruary 27, 2025
The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement
This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…
CertaraFebruary 25, 2025
