New Models and Applications in Predictive Toxicology

Dear Colleagues,

New approach methods (NAMs) are technologies and approaches, including computational modeling, in vitro assays, microphysiological systems, or testing using alternative animal species such as zebrafish that are predictive of hazard without the use of traditional animal studies. The FDA and other regulators worldwide will incorporate NAMS into regulatory assessments if certain data requirements are met. Regulators are adopting a context-of-use or fit-for-purpose approach. Any new method should have a clearly articulated description of the purpose for a particular new approach. It ideally should delineate the regulatory question or gaps to which the resulting data can be applied. The crucial question that new approach methods must answer are whether the data generated are predictive of and are translatable to humans (or pets or food animals). These are essential performance criteria for the acceptance of a new method into the regulatory paradigm. To be accepted into the regulatory process, it is anticipated that each NAM will be required to demonstrate a qualification program that incorporates several known chemicals, including both positive and negative controls that evaluate sensitivity and specificity.

The papers in this Special Edition will describe different emerging NAMs and how they can be used with confidence to answer regulatory decisions or fill regulator gaps. Of special interest will be the evaluation of NAMs for relevance to humans with or without using animals as the gold standard. Case studies of both successes and failures of the qualification process will be included in the issue.

Dr. A. Wallace Hayes
Dr. Steven J. Hermansky
Dr. Suzanne Compton Fitzpatrick
Guest Editors

Manuscript Submission Information

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