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Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development Blog Post

This blog will reflect on 3 things drug developers should pay attention to regarding safety when taking a new chemical entity or biologic drug into human testing.

Certara’s Simcyp Simulator Demo Blog Post

Simcyp PBPK Simulatorは、医薬品開発におけるPBPKモデリングの業界標準として最も広く活用されているプラットフォームです。ぜひデモをご覧ください。

Getting Results Faster – Supporting Physicians and Pharmacists with Biosimulation Technologies Blog Post

Certara’s Phoenix biosimulation software platform is widely used for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and population PK analysis. Recently, we have seen how Certara software helps customers accelerate collaboration across…

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus Blog Post

歴史的に、がん治療薬の投与戦略は最大耐容量に焦点が当てられてきました。This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely…

規制申請のためにeCTDベンダーを選定するのはいつが適切ですか？ Blog Post

貴社が医薬品の販売承認申請を規制当局に提出するにあたり、プロジェクト計画には多くの要素を考慮する必要があります。Among those is whom…

R speaks NLME (RsNLME) Page

RsNLMEは、Certara NLMEエンジンをRのコマンドラインから直接使用してモデルを実行できる、RパッケージおよびRShinyアプリのコレクションです。

Certara Acquires Integrated Nonclinical Development Solutions Blog Post

Expands software portfolio and nonclinical drug development expertise PRINCETON, N.J.— Jan 5, 2022– Certara, Inc., a global leader in biosimulation, today announced the acquisition of Integrated Nonclinical Development Solutions, Inc….

Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions Blog Post

FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices PRINCETON, N.J.— 2021年12月21日 – Certara, Inc. 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CERT), a global leader in biosimulation,…

P21 Releases New PMDA Validation Engine Blog Post

New PMDA Engine Pinnacle 21 is happy to announce the latest Validation Engine for submissions to Japan's PMDA! P21 has spent many months developing this Engine with and for the...

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3 Blog Post

On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures for medical devices and new non-compartmental analysis data. Moving to new versions of standards is...