Merck Advances Pediatric Oncology with Innovative ADC Modeling Case Study Merck Advances Pediatric Oncology with Innovative ADC Modeling Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…Certara2025年12月12日
Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings Announcement Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.Certara2025年12月3日
Using M&S to Evaluate Oncology Drug Dosing Blog Using M&S to Evaluate Oncology Drug Dosing Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…Certara2025年11月14日
Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema Publication Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…Certara2025年11月12日
Supporting KalVista’s NDA Submission for a Novel HAE Treatment Case Study Supporting KalVista’s NDA Submission for a Novel HAE Treatment To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…Danielle Pillsbury2025年11月12日
Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling Case Study Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…Certara2025年11月10日
Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient On-Demand Webinar Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient Watch the on-demand webinar on avoiding drug launch failure. Learn how smarter development, evidence, and…Certara2025年11月6日
Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis Publication Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…Certara2025年10月31日
Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer Case Study Certara & Dizal Partner to Fast-Track FDA Approval of Sunvozertinib for Lung Cancer Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…Certara2025年10月2日
37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT) Conference 37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT) Certara2025年9月22日