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…
Danielle Pillsbury2024 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…
Jim Gallagher2024 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…
Danielle Pillsbury2023 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
全世界约有 400,000 名先天性肾上腺增生症（CAH）患者。Current therapy for CAH uses a…
Becca Bucci2022 年 6 月 6 日
