Model-Informed Confidence in Oncology Dose Selection
Discover an oncology-focused company that gained confidence in their dose selection for an AML trial…
CertaraAugust 9, 2024
Certara’s MIDD Oncology Capabilities
Improve Oncology Study Decisions with Certara's MIDD Team Transcript: The pace of oncology drug…
CertaraAugust 7, 2024
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.…
CertaraJuly 12, 2024
Accelerating the Progress of Kinase Inhibitors in Oncology
The potential of PBPK modeling in answering key questions around these drugs. Hannah Jones, PhDMasoud…
CertaraMay 20, 2024
How to Navigate the FDA Landscape for an Orphan Drug
Rare diseases are a public health priority. FDA has launched several programs and a final…
CertaraFebruary 21, 2024
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…
CertaraDecember 19, 2023
FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in…
CertaraSeptember 20, 2023
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…
CertaraSeptember 20, 2023
