Clinical Pharmacology Archives

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

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…

Certara2025 年 11 月 5 日

On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

Certara2025 年 11 月 3 日

On-Demand Webinar

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

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

Certara2025 年 10 月 21 日

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…

Certara2025 年 10 月 16 日

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…

Certara2025 年 10 月 15 日

Live Events

PKUK 2025 Pre-Conference Workshop: Modeling & Simulation Updates – QSP and PK/PD Software

– Scarman, Coventry, UK

Certara2025 年 10 月 14 日

Blog

Alzheimer’s Disease Clinical Trials and Drug Development: Building a Robust Clinical Pharmacology & Model-Informed Strategy

Rajesh Krishna proposes using an integrated clinical pharmacology & model-informed strategy for Alzheimer's disease clinical…

Certara2025 年 10 月 7 日

White Paper

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

Replace or waive TQT studies with validated C-QT analysis strategies accepted by FDA, EMA, PMDA.…

Certara2025 年 10 月 3 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

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临床药理学

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

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

PKUK 2025 Pre-Conference Workshop: Modeling & Simulation Updates – QSP and PK/PD Software

Alzheimer’s Disease Clinical Trials and Drug Development: Building a Robust Clinical Pharmacology & Model-Informed Strategy

C-QTc and C-QT Analysis: Replacing TQT Studies and Accelerating Cardiovascular Safety Decisions

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

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