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.…
Danielle Pillsbury2024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
希少疾患は公衆衛生上の優先事項です。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…
Jim Gallagher2023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…
Danielle Pillsbury2023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…
Danielle Pillsbury2023年9月20日
Artificial Intelligence: What is it & how can it accelerate rare disease drug development?
Large & complex information streams present opportunities for the AI data scientist to aid in…
Certara2023年2月3日
Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer
Bispecific antibodies are an emerging class of antibodies developed in recent years that provide new…
Danielle Pillsbury2023年1月23日
Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease
先天性副腎過形成症（CAH）は、世界中でおよそ400,000人の患者さんがいます。Current therapy for CAH uses a…
Becca Bucci2022年6月6日
