New Approach Methodologies (NAMs) Archives

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 Pillsbury2025 年 11 月 7 日

On-Demand Webinar

In silico Safety and Toxicology assessment: ToxStudio®

Discover how Certara’s ToxStudio align with FDA’s roadmap to reduce animal testing and transform preclinical…

Certara2025 年 10 月 30 日

Press Coverage

Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research

The article, "Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research," explores a…

Danielle Pillsbury2025 年 9 月 10 日

Press Coverage

AI-driven drug discovery picks up as FDA pushes to reduce animal testing

AI is revolutionizing drug discovery and safety testing as drug developers adopt these technologies in…

Certara2025 年 9 月 9 日

On-Demand Webinar

无动物实验的洞察：利用人源化芯片与 PBPK 建模

Certara2025 年 7 月 29 日

Blog

如何实现药品研发中的动物实验向非动物实验的转型

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

Certara2025 年 7 月 25 日

Press Coverage

动物实验的终结？转向模型研究充满希望，但并非万能良方

The FDA has stated that the pharma industry must transition to using in vitro assays,…

Certara2025 年 7 月 21 日

Press Coverage

药物制造者：生物模拟时代

The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…

Danielle Pillsbury2025 年 7 月 1 日

Fact Sheet

Non-Animal Navigator™: 专家策略与 AI 生物模拟减少、优化或替代动物实验

Certara Non-Animal Navigator™ 解决方案通过以下方式助力企业转型：

Certara2025 年 4 月 30 日

Press Release

Certara 推出 Non-Animal Navigator™ 解决方案，助力药物开发者减少对动物试验的依赖

New offering provides strategic guidance and AI-enabled biosimulation to navigate FDA’s Roadmap to Reducing Animal…

Certara2025 年 4 月 14 日

New Approach Methodologies (NAMs)

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

In silico Safety and Toxicology assessment: ToxStudio®

Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research

AI-driven drug discovery picks up as FDA pushes to reduce animal testing

无动物实验的洞察：利用人源化芯片与 PBPK 建模

如何实现药品研发中的动物实验向非动物实验的转型

动物实验的终结？转向模型研究充满希望，但并非万能良方

药物制造者：生物模拟时代

Non-Animal Navigator™: 专家策略与 AI 生物模拟减少、优化或替代动物实验

Certara 推出 Non-Animal Navigator™ 解决方案，助力药物开发者减少对动物试验的依赖

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