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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 是药物研发领域 PBPK 建模的行业领导者及全球应用最广泛的平台。点击观看演示！

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

一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely…

我何时应该选择 eCTD 供应商来进行我的监管申报？ Blog Post

当贵公司着手向卫生监管部门提交上市申请的监管申报时，项目规划中需考量诸多因素，Among those is whom…

R speaks NLME (RsNLME) Page

RsNLME 为一套 R 程序包与 RShiny 应用程序的集合，使科研人员能够直接通过 R 命令行调用 Certara NLME 引擎运行模型。

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. （纳斯达克股票代码：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...