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Streamlining Pharmacokinetic Data Management with Certara’s Integral Blog Post

The PK scientist’s data pipeline handles a range of raw data types, including SAS, R, and other formats from multiple partners. This is particularly critical in complex trials with substantial…

How Biosimulation & AI Tech Could Solve Pharma’s R&D Productivity Crisis Blog Post

药物开发依然进展极为缓慢且成本高得惊人。In a 2010 article, Stephen Paul estimated that developing a new drug cost $1.8 billion and took thirteen years on…

Authoring & Assembling IND and CTA Applications – Insights and Updates Blog Post

Brenda TaylorDirector of Global Submissions Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical drug trials, and these applications have...

Advancing Rectal Drug Delivery: A Breakthrough in Physiologically Based Pharmacokinetic Modeling Blog Post

This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp PBPK Simulator for rectal drug absorption.

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog Post

In this blog post, we explore the top 10 things you need to know about eCTD 4.0, and its potential benefits for the pharmaceutical industry.

AAPS eChalk Talk: Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program Blog Post

The development of new drugs for rare diseases is a challenging process due to small patient populations and the high cost of clinical trials. One key challenge is identifying optimal dosing regimens….

Certara to Report Third Quarter 2023 Financial Results on November 8th, 2023, and participate in the Stephens Annual Investment Conference Blog Post

PRINCETON, N.J, Oct. 11, 2023 (GLOBE NEWSWIRE) — Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced that it will release financial results for the third quarter of…

Certara Acquires Formedix LLC to Increase Data Standardization Across Clinical Trials for Faster Study Setup, Time to Analysis and Submissions Blog Post

Formedix ryze cloud based clinical metadata repository and SDTM automation suite and Certara Pinnacle 21 data validation platform combine to power faster clinical trials Princeton, NJ – October 10th, 2023…

扩大规模和批准后变更 (SUPAC) 指导文件是否仍适用于药物开发人员？ Blog Post

Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV show, and for some inexplicable reason, hammer pants were a viable fashion option. But while…

GMP 2024 Symposium Blog Post