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266 积分 2025-09-01 加入
Manufacturing process development strategies for high concentration biologic drug products: from downstream processing to fill-finish
12天前
已完结
How to Replace the TQT Study—The Use of Concentration‐QTc Modeling to Exclude a Small Effect of a Novel Drug on QT Interval: Historical Perspective and Implementation
18天前
已完结
Optimizing 14C-Radiochemical Doses For Absorption, Distribution, Metabolism and Elimination (ADME) Studies: A Predictive Approach
21天前
已完结
Optimizing 14C-Radiochemical Doses For Absorption, Distribution, Metabolism and Elimination (ADME) Studies: A Predictive Approach
27天前
已关闭
Target identification and assessment in the era of AI
27天前
已完结
Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015–2024
28天前
已完结
Design, simulate, refine: simulation-guided clinical trials for accelerated drug development
28天前
已完结
FDA CDER analysis of non-human primate (NHP) data in monoclonal antibody (mAb) development to support the streamlining of nonclinical safety studies
29天前
已完结
Does Changing the Context of Use Change the Value Proposition of CiPA ?
30天前
已完结
Reply to: “The Future of Clinical Pharmacology: The Right Medicine at the Right Dose for Each Patient”
1个月前
已完结
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