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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

当社のPBPKモデリングソフトウェアは、医薬品開発におけるPBPKモデリングで最も多くの製薬企業や研究機関に利用されているプラットフォームです。Simcypᵐᶜプラットフォームの詳細はこちらをご覧ください。

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...

バイオ医薬品における臨床薬理計画の全体像とは？ Blog Post

モノクローナル抗体は、いまや多くの疾患治療に活用されており、患者に対して有効かつ安全な治療手段となっています。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

この取引によりサターラ社の収益、増収、補正EBITDAマージンが増加する見込み 2021年8月5日, サターラバイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) は本日、Pinnacle {{N:1}}（ピナクル21）社を現金・株式計{{N:2}}ミリオン...

Succeeding in Value Communication: Introduction Blog Post

BaseCaseコンサルティングチームの経験から得た知見をもとに、「本当に有効なコミュニケーションと成功方法」の入門編をお届けします。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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