PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
Becca Bucci2022年6月2日
Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another
Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…
Becca Bucci2022年6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…
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
ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial
Observational studies have postulated a therapeutic role of metformin in treating COVID-19. We conducted ...(cont.)
Jim Gallagher2021年12月22日
A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease
New therapeutics discovery and development for ocular diseases have been traditionally associated with a low…
Certara2021年12月15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
Certara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 Award
Biosimulation tool to conduct ‘what-if’ scenarios with virtual patients recognized in Software/Services category PRINCETON, NJ…
Jim Gallagher2021年10月25日
