Publication

肿瘤学中双特异性 T 细胞衔接子开发的给药策略与定量临床药理学

Bispecific T-cell Engagers (TCEs) are promising anti-cancer treatments that bind to both the CD3 receptors…

Certara2024 年 7 月 23 日

Press Coverage

加快激酶抑制剂在肿瘤学领域的应用进程

The potential of PBPK modeling in answering key questions around these drugs. Hannah Jones, PhDMasoud…

Certara2024 年 5 月 20 日

Publication

将实用性要素融入研究设计，优化肿瘤学随机临床试验

A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…

Certara2023 年 12 月 19 日

Poster

FDA 加速批准肿瘤适应症药物的趋势

The FDA has modified and increased expectations around data needed to support accelerated approvals in…

Certara2023 年 9 月 20 日

Poster

肿瘤药物早期临床试验中患者报告结局（PROs）的采用：挑战与机遇

Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…

Certara2023 年 9 月 20 日

Case Study

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

Blog

为什么 FDA 关于循环肿瘤 DNA 的新指南对肿瘤早期临床药物开发至关重要

2022 is shaping up to be the “year of the guidance” as the FDA has…

Certara2022 年 7 月 1 日

Case Study

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

博客

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

On-Demand Webinar

肿瘤药物开发人员应该从 FDA Project Optimus 中期待获得什么？

一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。This…

Certara2022 年 1 月 13 日

肿瘤学/血液学