Clinical Trials Archives

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Start right, finish strong: 抗体-药物偶联物（ADC）研究成功之道

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

Certara2026 年 2 月 23 日

Blog

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

Certara2026 年 2 月 18 日

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

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

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

Webinar

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

Certara2026 年 1 月 22 日

Blog

肿瘤精准剂量革命：Project Optimus下的适应性临床试验新范式

Leveraging adaptive clinical trial designs in oncology can accelerate drug development, while following the FDA…

Certara2026 年 1 月 16 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

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Start right, finish strong: 抗体-药物偶联物（ADC）研究成功之道

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

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

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants

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

肿瘤精准剂量革命：Project Optimus下的适应性临床试验新范式

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

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