Strategic Project Management for Accelerated Drug Development Fact Sheet Strategic Project Management for Accelerated Drug Development Expert project leadership to keep complex programs on track, aligned, and moving forward—so you can…Certara2025 年 12 月 23 日
A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection Publication A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection This study synthesizes data from a large body of clinical trials to evaluate rates of…Certara2025 年 12 月 18 日
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
Expedited Pharmacometrics Regulatory Submissions Fact Sheet Expedited Pharmacometrics Regulatory Submissions Certara delivers complete, compliant pharmacometric regulatory submission packages in just 4–6 weeks, eliminating the PMx…Certara2025 年 12 月 8 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
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
Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation Publication Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…Certara2025 年 11 月 5 日
Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights On-Demand Webinar Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…Certara2025 年 11 月 3 日