Model Informed Drug Development Archives

Blog

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…

CertaraJuly 23, 2025

Blog

MIDD can ease pediatric & rare disease drug loss in Japan

Certara tackles pediatric cancer and rare disease drug loss in Japan by advocating MIDD, which…

CertaraJuly 8, 2025

Case Study

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…

CertaraJuly 2, 2025

Blog

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

June 30, 2025 Drug development is increasingly defined by its complexity. Teams must navigate rising…

CertaraJune 30, 2025

Case Study

How Model-informed drug development rescue projects from a risky situation

Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve…

CertaraJune 26, 2025

Publication

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

Danielle PillsburyJune 19, 2025

On-Demand Webinar

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Discover the Real-World Impact of Model-Based Meta-Analysis. Hear from experts, see case studies to advance…

CertaraJune 18, 2025

On-Demand Webinar

Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis

CertaraJune 11, 2025

Publication

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…

CertaraJune 8, 2025

On-Demand Webinar

Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance

SVP, PBPK Consultancy Services, Certara SVP, Quantitative Science Services, Certara Sr. Director, Clinical Pharmacology, Certara…

CertaraMay 23, 2025

Model Informed Drug Development

ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered

MIDD can ease pediatric & rare disease drug loss in Japan

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

How Model-informed drug development rescue projects from a risky situation

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance

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