Therapeutic Specialties Archives

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle Pillsbury2026 年 3 月 4 日

Blog

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

Certara2026 年 3 月 3 日

Publication

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…

Certara2026 年 2 月 2 日

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

Certara2026 年 1 月 30 日

Publication

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…

Certara2026 年 1 月 22 日

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

治疗领域

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

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

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