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Time for change: non-human primates in drug research

Drug Target Review

This scarcity disrupts research timelines and limits the ability to replicate results across studies. The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs, when scientifically appropriate.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

In this article, we will define preclinical and clinical CROs, as well as highlight the unique needs and challenges of these organizations in their respective stages of drug research. The global preclinical CRO market was estimated to be valued at US$5.7 What is a Pre-Clinical CRO? over this period. between 2024 and 2030.

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Origins of the Lab Mouse

Codon

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market.