The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA Publication The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA CertaraMarch 4, 2024
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Certara Reports Fourth Quarter 2023 Financial Results Press Release Certara Reports Fourth Quarter 2023 Financial Results Provides Full Year 2024 Financial Guidance PRINCETON, N.J.— February 29, 2024-- Certara, Inc. (Nasdaq: CERT), a…CertaraFebruary 29, 2024
Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator Publication Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…CertaraFebruary 23, 2024
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Planning for a Successful EMA Policy 0070 Submission Press Coverage Planning for a Successful EMA Policy 0070 Submission CertaraFebruary 22, 2024
RAPS: How Will Generative AI Take Your Regulatory and Medical Writing Program to the Next Level? On-Demand Webinar RAPS: How Will Generative AI Take Your Regulatory and Medical Writing Program to the Next Level? Drug developers face increasing pressures to accelerate the drug development process, including reducing submission timelines.…CertaraFebruary 22, 2024
How to Navigate the FDA Landscape for an Orphan Drug Blog How to Navigate the FDA Landscape for an Orphan Drug Rare diseases are a public health priority. FDA has launched several programs and a final…CertaraFebruary 21, 2024
Dose Optimization Considerations for Targeted Radiation Therapies Blog Dose Optimization Considerations for Targeted Radiation Therapies The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio…CertaraFebruary 16, 2024
The interaction of core modules as a basis for elucidating network behavior determining Parkinson’s disease pathogenesis Publication The interaction of core modules as a basis for elucidating network behavior determining Parkinson’s disease pathogenesis It is well-established that misfolded alpha-synuclein (alpha-syn) is a histopathological marker of Parkinson's disease. Given…CertaraFebruary 14, 2024