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
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
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
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…
Certara2022 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.)
Certara2021 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…
Certara2021 年 10 月 25 日
Accelerating ADCs’ development pipeline using Simcyp PBPK
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…
Certara2021 年 10 月 15 日
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children
Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…
Certara2021 年 8 月 26 日
Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates
Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being…
Certara2021 年 8 月 26 日
