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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

Author(s): Lanyan Fang, Yuqing Gong, Andrew C Hooker, Viera Lukacova, Amin Rostami-Hodjegan, Mark Sale, Stella Grosser, Rebeka Jereb, Rada Savic, Carl Peck, Liang Zhao

Year: February 27, 2024

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The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA

Certara Showcases 2024 Research Wins with Over 100 Papers Published

Major Release of Certara GlobalSubmit™ Software Enhances the Regulatory Submission Process

Automated Writing Without the Compromise

Population K-PD Modeling of Plozasiran (ARO-APOC3), a GalNAc-siRNA Conjugate, for the Treatment of Patients with Severe Hypertriglyceridemi

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