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
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
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
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…
Certara2023 年 1 月 23 日
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials
Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…
Certara2022 年 4 月 11 日
什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
Certara2022 年 2 月 2 日
