Drug Development Archives

Blog

Pediatric Drug Development: From “Wild West” to Model-Informed Confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

Certara2026 年 2 月 11 日

Press Coverage

Why Many Global Drugs Never Reach Japan

Despite faster reviews, many global drugs never reach Japan. Learn how early development decisions, trial…

Certara2026 年 2 月 5 日

Publication

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

This study, published in Clinical Pharmacology & Therapeutics (CPT), shows how population pharmacokinetic modeling supports…

Certara2026 年 2 月 2 日

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

Certara2026 年 1 月 30 日

Blog

P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0

Pinnacle 21 supports TIG v1.0, the CDISC Tobacco Implementation Guide for FDA CTP, enabling automated…

Certara2026 年 1 月 30 日

Blog

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

Learn how Model-Informed Drug Development strengthens drug asset valuation by reducing uncertainty, predicting clinical performance,…

Certara2026 年 1 月 26 日

Publication

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

This article explores how model-based meta-analysis (MBMA) performs when combining aggregate data and individual patient…

Certara2026 年 1 月 22 日

On-Demand Webinar

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

Watch this on-demand webinar to learn how model-based meta-analysis (MBMA), quantitative systems pharmacology (QSP), and…

Certara2026 年 1 月 22 日

Webinar

CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

Certara2026 年 1 月 14 日

On-Demand Webinar

监管前沿：全球战略洞察与 2026 展望，来自主要监管机构前任领导者的洞见

Watch this on-demand webinar featuring former regulators as they share global regulatory trends and clinical…

Certara2026 年 1 月 14 日

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Pediatric Drug Development: From “Wild West” to Model-Informed Confidence

Why Many Global Drugs Never Reach Japan

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

P21 Enterprise Expands Regulatory Validation Capabilities with Support for the Tobacco Implementation Guide v1.0

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

Combining Aggregate Data and Individual Patient Data in Model-Based Meta-Analysis: An Illustrative Case Study of Tofacitinib in Rheumatoid Arthritis Patients

Model-Based Meta-Analysis (MBMA), Quantitative Systems Pharmacology (QSP), and Advanced Modeling in Early Reimbursement Strategy

CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

监管前沿：全球战略洞察与 2026 展望，来自主要监管机构前任领导者的洞见

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