While development of humane endpoints for animals in preclinical safety studies is not an easy process, it is an absolute necessity. And although humane endpoints must be established for obvious ethical reasons, it’s easy to overlook how much they can contribute to the success of a trial, ultimately helping to save valuable time and resources.
Additionally when thought and eff ort are put into developing humane endpoints pre-study, information can be gathered on the test article’s mechanism of toxicity, which makes the study results more useful to stakeholders.
Some scientists erroneously think that because the FDA defines what they need to see in a safety trial, they can’t develop humane endpoints. Though the FDA is specific about what data comes from a study, humane endpoints must be developed. In fact, though regulations on laboratory animal welfare have existed for years, the FDA is more alert than ever to the ethical treatment of animals, and auditors may pass along a company’s name to other regulatory agencies (e.g. the USDA) if evidence of non-compliance is found during audits.
Why are humane endpoints difficult to develop?
Humane endpoints are different for every drug being developed, where the drug is in the drug development process, the goals of the current study, and what was learned in the previous study. Though there are no standard endpoints that can be applied to every study, there are some concepts that should be taken into account. This article describes the six basic concepts needed to establish humane endpoints prior to safety studies, and provides a sample case.
Additionally when thought and eff ort are put into developing humane endpoints pre-study, information can be gathered on the test article’s mechanism of toxicity, which makes the study results more useful to stakeholders.
Some scientists erroneously think that because the FDA defines what they need to see in a safety trial, they can’t develop humane endpoints. Though the FDA is specific about what data comes from a study, humane endpoints must be developed. In fact, though regulations on laboratory animal welfare have existed for years, the FDA is more alert than ever to the ethical treatment of animals, and auditors may pass along a company’s name to other regulatory agencies (e.g. the USDA) if evidence of non-compliance is found during audits.
Why are humane endpoints difficult to develop?
Humane endpoints are different for every drug being developed, where the drug is in the drug development process, the goals of the current study, and what was learned in the previous study. Though there are no standard endpoints that can be applied to every study, there are some concepts that should be taken into account. This article describes the six basic concepts needed to establish humane endpoints prior to safety studies, and provides a sample case.