New Approach Methodologies (NAMs) Archives

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The FDA’s new draft guidance clarifies how drug developers can validate and use non-animal testing…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

On-Demand Webinar

Safety First: Uncovering the Clinical Risks Inside Your Compound Screening Data

Learn how to interpret screening assay data to predict clinical off-target risk with ToxStudio® and…

CertaraJanuary 13, 2026

Guide Infographic

New Approach Methodologies (NAMs): By the numbers

We outline today’s animal-use landscape, the rise of NAMs, & how the Non-Animal Navigator supports…

CertaraDecember 10, 2025

Podcast Press Coverage

New Approach Methodologies: Redefining Animal Testing Alternatives

Explore how New Approach Methodologies (NAMs) and advanced in silico and in vitro tools are…

CertaraDecember 10, 2025

Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

The FDA is phasing out animal testing of new drugs. Learn how Certara’s Non-Animal Navigator™…

CertaraNovember 17, 2025

Announcement

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH…

CertaraNovember 12, 2025

Publication

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Immunogenicity poses a significant challenge in biotherapeutics development due to the formation of anti-drug antibodies…

Danielle PillsburyNovember 7, 2025

New Approach Methodologies (NAMs)