Clinical Pharmacology Archives

Publication

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

The paper reviews current applications of pediatric PBPK across therapeutic areas and outlines where PBPK…

CertaraNovember 21, 2025

Blog

Using M&S to Evaluate Oncology Drug Dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

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…

CertaraNovember 12, 2025

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 PillsburyNovember 12, 2025

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…

CertaraNovember 10, 2025

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…

CertaraNovember 5, 2025

Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Danielle PillsburyNovember 3, 2025

Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

CertaraOctober 21, 2025

Blog

Streamlining PK/PD Reporting: A Smarter Approach to Generating Tables, Figures and Listings

Discover how TFL Studio accelerates PK/PD reporting. Create audit-ready tables, figures, and listings faster with…

CertaraOctober 16, 2025

Publication

Effective Visualizations Using “vachette” to Assess and Communicate Pharmacometric Model Results

Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…

CertaraOctober 15, 2025

Clinical Pharmacology

Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges

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

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Streamlining PK/PD Reporting: A Smarter Approach to Generating Tables, Figures and Listings

Effective Visualizations Using “vachette” to Assess and Communicate Pharmacometric Model Results

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