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Why Do Preclinical Humane Endpoints Matter?

When people are suffering or dying from disease, there’s a powerful incentive to move new treatments through the pipeline as quickly as possible. But while speed is important, it cannot come at the expense of quality and compliance.  The care of animals involved in preclinical safety studies is a compliance expectation by several regulatory bodies, and because the animal is the test system, good animal welfare is also good science.

Establishing humane endpoints before a study begins is the right thing to do. It is an ethical expectation of the public, and it makes good business sense; humane endpoints can reveal crucial insights on a drug candidate’s mechanism of action and strengthen the rationale for a go/no-go decision.

Identifying humane endpoints and including them in a study design can be a challenge. The goal is to set criteria that meet study objectives while ending the study as early as possible to avoid or stop unrelieved pain or distress in an animal. That goal aligns with guidance from the National Institute of Health (NIH) Office of Animal Welfare. A study that carries on past those criteria is neither humane nor scientifically justified.

Full article at Drug Discovery Online

New ALTEX:2/2018

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MeetingS

 
Building a Better Epithelium: Breaking the Barrier to the Next Generation of Toxicity Testing
March 10, 2018
San Antonio, TX

SOT Satellite Meeting: Updates on Activities Related to 21st Century Toxicology and Related Efforts: Invited Presentations and Open Mic
March 15, 2018
San Antonio, TX

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Social Housing Workshop
June 4-5, 2018
Beltsville, MD
Email: kherrma1@jhu.edu

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2nd Pan-American Conference for Alternative Methods
August 23-24, 2018
Rio de Janeiro, Brazil 

Eurotox 2018
September 2-5, 2018
Brussels, Belgium

20th International Congress on In Vitro Toxicology (ESTIV2018)
October 15-18, 2018
Berlin
 

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