Secure your complimentary copy of the authoritative book on PK/PD modeling.
Welcome to the Certara Inner Circle! The monthly newsletter to keep you on track for the toughest challenges in drug development today.

Secure your complimentary copy of the authoritative book on PK/PD modeling.

While it’s hard to believe 2023 is almost over, we are excited to embark on a new year full of meaningful scientific collaborations and approvals of new therapies that positively impact human health. Our final newsletter of 2023 is full of insights on biosimulation and regulatory science from our most viewed blogs and downloaded content in 2023. The topics range from Oncology best practices in the time of Project Optimus to new ways to make it easier to manage PK data across the Phoenix suite. Whether you are planning the next milestone in your development program or are working on the next big scientific breakthrough, Certara is here to help.

Contact us if you need to de-risk your most critical decisions, increase your R&D productivity, or improve patient outcomes. From our family to yours, we wish you a wonderful holiday season and very happy 2024.

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BLOG: What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

This blog explains what the historic maximum tolerated dose approach for oncology drugs involves, and why the FDA’s Project Optimus has moved away from it.  

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EBOOK: Pharmacokinetic and Pharmacodynamic Data Analysis, PK/PD Concepts and Applications

Register to get FREE, exclusive access to Johan Gabrielsson and Dan Weiner’s standard book for PK/PD scientists!  

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WHITE PAPER: Understanding Europe’s New Clinical Trial Regulations

This white paper will help you understand the goals of EU-CTR, the challenges that drug developers face in adapting to this new system, and recommendations on best practices to address these challenges. 

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CASE STUDY: How A Biotech Startup Company Increased Flexibility and Efficiency by Switching to Phoenix Hosted

Read this case study to learn why a biotech adopted Phoenix Hosted to reduce the burden on their IT team and allow their scientists to focus on accelerating the development of treatments against cancer.  

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CASE STUDIES: PBPK Applications (MIFD) Using the Simcyp Simulator

The following case studies illustrate why sponsors and regulatory agencies are leaning into using model-informed formulation development to streamline new and generic drug programs.  

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SOFTWARE: Pinnacle 21 Enterprise CDISC Software

Learn how Certara's Pinnacle 21 data standardization platform is used to prepare and standardize clinical data for analysis and regulatory submissions.  

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About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Corporate Headquarters: 100 Overlook Center, Suite 101, Princeton, NJ 08540 USA


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