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
Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology
Bispecific T-cell Engagers (TCEs) are promising anti-cancer treatments that bind to both the CD3 receptors…
Certara2024 年 7 月 23 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
Why FDA’s new guidance on circulating tumor DNA is critical for oncology early clinical drug development
2022 is shaping up to be the “year of the guidance” as the FDA has…
Certara2022 年 7 月 1 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
