This eBook explores how new approach methodologies (NAMs), with FDA authorization, can support investigational new drugs and phase out animal studies.
In the pharmaceutical industry, animal testing has been standard practice for evaluating the safety and efficacy of new drugs, but the research comes at a cost. These studies are expensive, slow and rife with ethical issues. Overreliance on animal studies has even led to clinical trial failures and unsafe medications. Now new approach methodologies (NAMs) are gaining acceptance as alternatives to animal studies.
This eBook explores the combination of ethical concerns and limitations that has led to an increased focus on NAMs instead of animal testing, and recent FDA guidance for NAMs. Highlights include:
- How AI-driven modeling and simulation make it possible to move away from animal testing.
- The role of short-term hybrid approaches and medium-term expanded NAM adoption in the transition to animal-free drug development.
- A forward-thinking partner that can provide strategic solutions to support faster, smarter, more ethical drug development that aligns with evolving regulations.
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