New Models and Applications in Predictive Toxicology
A special issue of Toxics (ISSN 2305-6304). This special issue belongs to the section "Novel Methods in Toxicology Research".
Deadline for manuscript submissions: closed (28 February 2024) | Viewed by 3265
Special Issue Editors
Interests: toxicology; food safety; molecular biology; chemical safety; environmental toxicology
Interests: food toxicology; risk communication; new methods
Special Issue Information
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
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Toxics is an international peer-reviewed open access monthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
Keywords
- 3 Rs
- in vivo
- in silico
- context of use
- fit for purpose
