Model-Informed Confidence in Oncology Dose Selection
Discover an oncology-focused company that gained confidence in their dose selection for an AML trial…
Certara2024 年 8 月 9 日
Certara’s MIDD Oncology Capabilities
Improve Oncology Study Decisions with Certara's MIDD Team Transcript: The pace of oncology drug…
Certara2024 年 8 月 7 日
Systems Modeling Delivers Efficiencies and Savings in Clinical Development
Discover how an IO-focused company developing immunotherapies applied QSP modeling solutions for cost-effective clinical development.…
Certara2024 年 7 月 12 日
Accelerating the Progress of Kinase Inhibitors in Oncology
The potential of PBPK modeling in answering key questions around these drugs. Hannah Jones, PhDMasoud…
Certara2024 年 5 月 20 日
How to Navigate the FDA Landscape for an Orphan Drug
罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final…
Certara2024 年 2 月 21 日
Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials
A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…
Certara2023 年 12 月 19 日
FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in…
Certara2023 年 9 月 20 日
Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities
Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…
Certara2023 年 9 月 20 日
