Oncology/Hematology Archives

Article

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…

Danielle Pillsbury2024 年 5 月 20 日

Publication

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

Poster

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

Poster

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

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…

Danielle Pillsbury2023 年 1 月 23 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…

Jim Gallagher2022 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…

Jim Gallagher2022 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…

Jim Gallagher2022 年 1 月 13 日

On-Demand Webinar

抗体-药物偶联物的 PBPK 模型 — 概念和应用

Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…

Jim Gallagher2022 年 1 月 13 日

Blog

开发靶向共价抑制剂药物：3关键考虑因素

Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…

Jim Gallagher2021 年 11 月 5 日

肿瘤学/血液学