Clinical Pharmacology Archives

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Improve pediatric drug development with Certara’s Pediatric Practice, MIDD expertise for PIPs/PSPs, dose selection, regulatory…

CertaraNovember 10, 2025

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…

CertaraNovember 6, 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

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.…

CertaraNovember 3, 2025

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…

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

Live Events

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

– Scarman, Coventry, UK

CertaraOctober 14, 2025

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…

CertaraOctober 7, 2025

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.…

CertaraOctober 3, 2025

Clinical Pharmacology

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

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

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