Certara Acquires Applied Biomath Expanding Its Biosimulation Portfolio to Industrialize New Capabilities for Optimal Dosing for Novel Therapies Blog Post
Certara和Applied Biomath联合建立生命科学行业最大的定量系统药理学(QSP)高级研究中心,有助于更快、更有效地开发药物。Princeton, NJ – December 14th, 2023 ...
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Post
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. 由于 SDTM...
Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator Blog Post
Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies for 40 Kinase Inhibitor (KI) drugs.

Pharma Focus Europe – Issue 03 – Using AI to Accelerate Drug Development Blog Post
Authors: Professor Amin Rostami-Hodjegan, Professor Piet van der Graaf This Pharma Focus EU article, co-authored by Amin Rostami-Hodjegan, SVP of Research & Development and CSO at Certara, and Professor Piet…

Certara Launches Updated Version of Pirana Modeling Workbench Blog Post
PRINCETON, N.J.— 2023 年 12 月 1 日 – Certara, Inc., a global leader in biosimulation, today announced the release of version 23.10.1 of Pirana, a workbench solution that simplifies and harmonizes the…

Creation of novel sensitive probe substrate and moderate inhibitor models for a comprehensive prediction of CYP2C8 interactions for tucatinib Blog Post
Authors: Ian E. Templeton, Karen Rowland-Yeo, Hannah M. Jones, Christopher J. Endres, Ariel R. Topletz-Erickson, Hao Sun, Anthony J. Lee A physiologically based pharmacokinetic (PBPK) model was developed to simulate plasma concentrations of tucatinib (Tukysa®) after…

Certara introduces Simcyp™ Biopharmaceutics software to increase efficiency of novel and generic drug formulation & development Blog Post
Simcyp Biopharmaceutics helps drug developers replace costly clinical bioequivalence studies and optimize formulations for complex therapies Princeton, NJ – November 21st, 2023 – Certara, Inc. (纳斯达克股票代码:CERT), a global leader…

Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies Blog Post
癌症治疗已从一般细胞毒性疗法发展为针对癌细胞中特定通路和变异的药物。Patients tolerate targeted therapies better, and their treatment continues over a…

动物规则 -- 如果临床试验根本不符合道德规范怎么办? Blog Post
Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy. Sometimes, the challenges are beyond difficult, presenting situations where it isn’t ethical or feasible to demonstrate efficacy…