What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
CertaraFebruary 2, 2022
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…
CertaraJanuary 13, 2022
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…
CertaraJanuary 13, 2022
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.)
CertaraDecember 22, 2021
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…
CertaraDecember 15, 2021
Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…
CertaraNovember 5, 2021
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…
CertaraOctober 25, 2021
Accelerating ADCs’ development pipeline using Simcyp PBPK
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…
CertaraOctober 15, 2021
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…
CertaraAugust 26, 2021
