Certara Services Archives

Guide

Guided by Evidence: Preparing for ICH M15 and the Next Evolution of Model-Informed Drug Development

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

Certara2026 年 2 月 13 日

Guide

EMA Policy 0070 Submission Readiness Checklist

Use this EMA Policy 0070 Submission Checklist to prepare compliant clinical data packages, manage anonymization…

Certara2026 年 2 月 12 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

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

Conference

AI in Drug Discovery 2026

Certara2026 年 1 月 30 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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