Publication

Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting

Find out how PopPK model links higher venetoclax exposure to MRD-negative status in pediatric AML…

CertaraMarch 20, 2026

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…

CertaraMarch 19, 2026

Press Coverage Video

Rethinking Trial Design With Bayesian Approaches

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

CertaraMarch 19, 2026

Blog

The future of payer engagement in pharma: Rethinking how value is communicated

A detailed analysis of strategies for payer engagement in pharma and how digital payer engagement…

Christian PichardoMarch 19, 2026

Blog Knowledge Base

What is GLP (good laboratory practice)?

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

Kevin Snyder, PhDMarch 18, 2026

Blog

ICH M15 guideline: What the finalized guideline means for model-informed drug development

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraMarch 18, 2026

Publication

Creatinine- and cystatin C-based population pharmacokinetic models for predicting mycophenolic acid clearance in patients with autoimmune diseases

Explore how creatinine-based equations best predict MPA clearance in autoimmune disease patients in a Phoenix…

CertaraMarch 18, 2026

Publication

Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

Discover how replicated crossover study shows propafenone formulations meet bioequivalence criteria despite high within-subject variability.

CertaraMarch 18, 2026

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…

CertaraMarch 17, 2026

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 PillsburyMarch 13, 2026

Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting

Pediatric Drug Development and Pharmacometrics: Key Questions Sponsors Must Answer

Rethinking Trial Design With Bayesian Approaches

The future of payer engagement in pharma: Rethinking how value is communicated

What is GLP (good laboratory practice)?

ICH M15 guideline: What the finalized guideline means for model-informed drug development

Creatinine- and cystatin C-based population pharmacokinetic models for predicting mycophenolic acid clearance in patients with autoimmune diseases

Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

Why you should participate in the voluntary FDA oncology center of excellence assessment aid program

FDA Support Drives Shift Toward Bayesian Trial Design

Newsletter sign up

Quick links

Solutions

Contact