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Year: 2020

Certara’s Phoenix software supports training of the next generation of the pharmacometricians in China

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The Pharmacy department of the Shanghai Chest Hospital is dedicated to developing and applying model-informed precision dosing (MIPD) and model-informed drug development (MIDD) models to optimize dosing for patients in China.  Certara has partnered with Professor Jiao for 20 years to provide academic training to graduate students and researchers on using its pharmacometric software, including … Continued

Certara Announces Launch of Initial Public Offering

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PRINCETON, NJ.— December 3, 2020 – Certara, Inc. (“Certara”) today announced the launch of its initial public offering of 24,390,000 million shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission. Certara is offering 14,630,000 shares of common stock and certain selling stockholders are offering 9,760,000 shares of … Continued

Mechanistic model-informed discovery & development of bispecific antibodies for immuno-oncology: It takes 2 to tango

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More than 50 bispecific antibodies are in oncology clinical development with a large diversity in formats, directed at a range of immune and tumor targets. Bispecifics have demonstrated the potential for enhanced efficacy and reduced systemic toxicity. However, they are complex modalities with challenges to overcome in early clinical trials, including selection of relevant starting … Continued

Getting Real with RWE

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By Taren Grom Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain.

Regulatory submissions and transactions with Health Canada

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By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.  Health Canada implements eCTD for Clinical Trial Applications Health Canada accepts electronic Common Technical Document (eCTD) … Continued

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