New Approach Methodologies (NAMs) Archives

Press Coverage

FDA Rebuilding After DOGE Cuts: Former Regulators Speak Out

Former FDA officials describe the impact of DOGE-era staffing cuts, lost expertise, and the challenges…

CertaraMay 15, 2026

Guide

How to Leverage PBPK Modeling and Simulation in Drug Research and Development

Learn how PBPK modeling and simulation in drug research and development reduces clinical burden, supports…

CertaraMay 12, 2026

Webinar

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

CertaraMay 8, 2026

Blog

How Pharma Can Transition to Non-animal Studies for Investigational Drugs

Pharma companies can ease the transition to non-animal studies for investigational drugs by leveraging NAMs…

CertaraMay 5, 2026

Blog

From Models to Impact: What QSPC 2026 Revealed About the Future of Drug Development

Explore Certara’s insights from QSPC 2026, including virtual patients, regulatory adoption, AI in QSP, and…

CertaraApril 28, 2026

Fact Sheet

ToxStudio® Predictive Toxicology Software

Learn about ToxStudio: Predictive toxicology software to support prediction of drug-induced liver injury (DILI), QT…

CertaraApril 16, 2026

Press Coverage

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

The FDA’s new draft guidance clarifies how drug developers can validate and use non-animal testing…

CertaraApril 1, 2026

Blog

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

Learn how regulatory expectations in clinical pharmacology are evolving and how to build a strategy…

CertaraMarch 24, 2026

Blog

How Quantitative Systems Pharmacology Addresses Key Challenges in Alzheimer’s Drug Development

Quantitative Systems Pharmacology (QSP) helps address key challenges in Alzheimer’s disease drug development, including tau…

CertaraFebruary 2, 2026

On-Demand Webinar

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

Watch this on-demand webinar to learn how model-based meta-analysis (MBMA), quantitative systems pharmacology (QSP), and…

CertaraJanuary 22, 2026

New Approach Methodologies (NAMs)

FDA Rebuilding After DOGE Cuts: Former Regulators Speak Out

How to Leverage PBPK Modeling and Simulation in Drug Research and Development

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

How Pharma Can Transition to Non-animal Studies for Investigational Drugs

From Models to Impact: What QSPC 2026 Revealed About the Future of Drug Development

ToxStudio® Predictive Toxicology Software

FDA Blueprint Aims To Cut Regulatory Risk for Alternatives to Animal Testing

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

How Quantitative Systems Pharmacology Addresses Key Challenges in Alzheimer’s Drug Development

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

Newsletter sign up

Quick links

Solutions

Contact