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…
Certara2025年3月4日
How the US FDA MIDD paired pilot program helps sponsors
2025年2月28日 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…
Certara2025年2月28日
Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe
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Certara2025年2月28日
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 : 薬物吸収モデルとは？Part 3 in…
Certara2025年2月27日
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…
Certara2025年2月25日
