Modeling and Simulation - PK/PD Archives

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

Blog

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

At ACoP 2025, Certara showcased innovation with the launch of Certara IQ™ and Phoenix® Cloud,…

CertaraNovember 13, 2025

Webinar

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

CertaraNovember 13, 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

Blog

Empowering the PK Community: Insights from the Phoenix® User Events

Explore insights from the Phoenix User Events in Europe, where experts shared innovations in automation,…

CertaraNovember 3, 2025

Blog

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…

CertaraOctober 24, 2025

Modeling and Simulation – PK/PD

Using M&S to Evaluate Oncology Drug Dosing

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

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

Empowering the PK Community: Insights from the Phoenix® User Events

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

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