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…
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
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
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
米国FDAが主導する「プロジェクト・オプティマス」とは？
がん治療薬開発にどのような影響を与えるのか？
がん治療薬開発にどのような影響を与えるのか？
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
Certara2022年2月2日
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
歴史的に、がん治療薬の投与戦略は最大耐容量に焦点が当てられてきました。This…
Jim Gallagher2022年1月13日
PBPK Modeling of Antibody-Drug Conjugates – Concept and Application
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…
Jim Gallagher2022年1月13日
Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…
Certara2021年11月5日
