Pharmacometrics Archives

Blog

Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions

Explore how PMx regulatory submissions, exposure-response modeling, and strategic pharmacometrics planning support successful and timely…

Certara2025 年 12 月 29 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

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…

Certara2025 年 10 月 24 日

Blog

肿瘤领域模型引导的药物开发（MIDD）精要

Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…

Certara2025 年 10 月 6 日

Blog

基于 MIDD 重塑监管策略：《ICH M15 指南草案》深度剖析

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

Certara2025 年 6 月 11 日

On-Demand Webinar

Phoenix NLME & Pirana 双擎驱动：群体 PK 建模高效精准实战解析 [亚太地区网络研讨会]

Senior Director, Pharmacometric Software, Certara Keith has more than 20 years of global drug development…

Certara2025 年 4 月 24 日

Publication

HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究（IMPAACT 2017/MOCHA）：一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

Certara2025 年 3 月 20 日

Publication

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…

Certara2025 年 2 月 25 日

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定量药理学

Delivering on Deadline: Why Pharmacometrics (PMx) Is the Anchor of Successful Regulatory Submissions

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

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

肿瘤领域模型引导的药物开发（MIDD）精要

基于 MIDD 重塑监管策略：《ICH M15 指南草案》深度剖析

Phoenix NLME & Pirana 双擎驱动：群体 PK 建模高效精准实战解析 [亚太地区网络研讨会]

HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究（IMPAACT 2017/MOCHA）：一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

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