Certara Services Archives

eBook

The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration

Discover advanced regulatory writing strategies, global regulatory submission best practices, eCTD guidance, ICH M15 updates…

Certara2026 年 3 月 26 日

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

Certara2026 年 3 月 25 日

On-Demand Webinar

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…

Certara2026 年 3 月 25 日

Press Coverage Video

Building Smarter Trials With Bayesian Statistics

Learn how Bayesian statistics are transforming clinical trials with adaptive designs, faster insights, and more…

Certara2026 年 3 月 24 日

Publication

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…

Danielle Pillsbury2026 年 3 月 24 日

Guide

Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer

Download Certara’s expert guide on pharmacometrics and pediatric drug development. Learn how modeling, MIDD, and…

Certara2026 年 3 月 19 日

Press Coverage Video

Rethinking Trial Design With Bayesian Approaches

Learn how Bayesian approaches are transforming clinical trial design by enabling adaptive studies, data borrowing,…

Certara2026 年 3 月 19 日

Blog Knowledge Base

What is GLP (Good Laboratory Practice)?

Read this blog to understand GLP (Good Laboratory Practice) and associated QA audits, and proper…

Certara2026 年 3 月 18 日

Blog

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

Learn how the FDA assessment aid streamlines oncology NDA/BLA reviews, what to include, and best…

Certara2026 年 3 月 17 日

Press Coverage Video

FDA Support Drives Shift Toward Bayesian Trial Design

Explore how Bayesian statistical methods are reshaping clinical trial design. Learn how FDA support, adaptive…

Danielle Pillsbury2026 年 3 月 13 日

Certara 服务

The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Building Smarter Trials With Bayesian Statistics

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer

Rethinking Trial Design With Bayesian Approaches

What is GLP (Good Laboratory Practice)?

Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program

FDA Support Drives Shift Toward Bayesian Trial Design

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