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While it’s hard to believe 2023 is almost over, we are excited to embark on a new year full of meaningful scientific collaborations
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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.
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!
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.
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.
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.
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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Where to find Certara this Winter
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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