Therapeutic Specialties Archives

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

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

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

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

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

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

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

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

Case Study

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

Certara’s support enabled fast-track FDA oncology approval 2025 for Sunvozertinib, a breakthrough NSCLC therapy targeting…

Certara2025 年 10 月 2 日

Conference

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

Certara2025 年 9 月 22 日

治疗领域

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Using M&S to Evaluate Oncology Drug Dosing

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Certara 与迪哲强强联手助力舒沃替尼斩获FDA肺癌适应症加速批准

37th Annual Meeting of the Southern California Chapter Society of Toxicology (SCCSOT)

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