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Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations Blog Post

The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc….

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Blog Post

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October 2015 at monthly and 6-week dosing options. Although aripiprazole was not a new drug, Aristada...

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Blog Post

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating advanced melanoma. As in the best practice case of ibrutinib, we generally perform physiologically-based pharmacokinetic...

On Demand Webinars Page

On Demand Webinars Keep up to date with the latest resources Sign up Featured on-demand webinar Pharmacokinetic Modeling of Neutralizing ADA Effects in Translational Development Latest on-demand webinars Clinical and...

Simcyp Page

我们的 PBPK 建模软件是药物开发中最广泛采用的 PBPK 建模平台。点击此处了解有关 Simcyp™ 平台的更多信息。

Simcyp Success Stories Page

Simcyp™ Success Stories Simcyp has led the way in the development and application of physiologically-based pharmacokinetics (PBPK) in drug development. From addressing safety issues such as drug-drug-interaction (DDI), to extrapolation...

生物制剂的临床药理计划是怎样的？ Blog Post

单克隆抗体现已被广泛应用于多种疾病的治疗，为患者提供有效且安全的治疗方案。Due to their molecular and biological specificities, their clinical and…

Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data Blog Post

Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton, N.J., 2021 年 8 月 5 日 – Certara, Inc. （纳斯达克股票代码：CERT）今日宣布任命李改玲博士(Gailing Li, Ph.D.)为高级副总裁兼中国区首...

Succeeding in Value Communication: Introduction Blog Post

本文基于 BaseCase 咨询团队的实践经验，系“价值传播制胜之道”系列导言。This series of blog articles examines the key success factors in creating…

Takeover of lifecycle maintenance of investigational new drug applications Blog Post

A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for Lifecycle Maintenance (LCM) of their INDs. It was important to the Sponsor team that they received better responsiveness and minimal...

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