The “Toxicity Testing in the 21st Century” published by US National Research Council emphasizes “paradigm shift” of toxicological test methods such as to move away from use of laboratory animals towards those that use human cells, cell lines and organoids. Subscribing to this report, the US FDA, US EPA, NIEHS/NTP, and the NCATS have developed methods for toxicity testing that help usher in chemical toxicity testing into the 21st century which involve development of novel approach methods (NAMs) using human cells, cell lines and organoids for state-of-the-art risk assessment.
Besides, in 2017, the US FDA published a predictive toxicology roadmap entitled 'A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products'. As a part of efforts to strengthen that commitment, FDA launched its Alternative Methods Working Group (Alternative Methods Group). In 2018, US EPA published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the Toxic Substances Control Act (TSCA) Program. It was announced that EPA will stop conducting or funding studies on mammals by 2035. The move which is already eliciting strong reactions from groups supporting or opposing experiments on animals makes EPA the first Federal Agency to put a rigid deadline on phasing out animal research.
On the other hand, EU focuses on implementing the Three Rs, Reduction- Refinement, and Replacement,- through the development of non-animal tests methods for use in a bottom–up approach. The EU-ToxRisk project aims to develop and implement NAMs as an alternative approach for the safety testing of chemicals. EU-ToxRisk has assembled a wide panel of the state-of-the-art in silico and in vitro test methods, which allow for the testing of systemic repeated dose target organ toxicity (RDT), covering liver, kidney, lung and neuronal system as target organs, as well as experimental systems that cover developmental and reproductive toxicity (DART). The project's objective is to assess the application of NAMs as a tool to improve read-across, as well as in the context of ab initio chemical safety assessment.However, multiple non-animal-based test methods have never been formally validated. In order to use such NAMs in the regulatory context, criteria are being brought up in international organizations to define their readiness. In view of this international situation, researchers from Asia are also contributing to development of NAMs. They have come forward to coordinate the development to of NAMs in a regulatory context in their respective countries.
In this Research Topic the Topic Editors intend to spotlight current activities pertaining to NAMs, discovery of newer IVT approaches as well as adoption of the existing and upcoming methods, by Asian researchers. The Topic Editors encourage authors to contribute manuscripts on current activities related to the development of newest NAMs in each country, and also on the adoption of newer methods in their research and regulatory context, e.g. IVT as a multifaceted and multi-dimensional tool, ranging from the simple 2-D flat culture to 3-D culture to organs-on-chip to organoids-on-chip to multi-organ-on-chip to human-on-chip to 3-D printing, as well as stem cell science and all advanced analytical and imaging technologies.
The “Toxicity Testing in the 21st Century” published by US National Research Council emphasizes “paradigm shift” of toxicological test methods such as to move away from use of laboratory animals towards those that use human cells, cell lines and organoids. Subscribing to this report, the US FDA, US EPA, NIEHS/NTP, and the NCATS have developed methods for toxicity testing that help usher in chemical toxicity testing into the 21st century which involve development of novel approach methods (NAMs) using human cells, cell lines and organoids for state-of-the-art risk assessment.
Besides, in 2017, the US FDA published a predictive toxicology roadmap entitled 'A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products'. As a part of efforts to strengthen that commitment, FDA launched its Alternative Methods Working Group (Alternative Methods Group). In 2018, US EPA published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the Toxic Substances Control Act (TSCA) Program. It was announced that EPA will stop conducting or funding studies on mammals by 2035. The move which is already eliciting strong reactions from groups supporting or opposing experiments on animals makes EPA the first Federal Agency to put a rigid deadline on phasing out animal research.
On the other hand, EU focuses on implementing the Three Rs, Reduction- Refinement, and Replacement,- through the development of non-animal tests methods for use in a bottom–up approach. The EU-ToxRisk project aims to develop and implement NAMs as an alternative approach for the safety testing of chemicals. EU-ToxRisk has assembled a wide panel of the state-of-the-art in silico and in vitro test methods, which allow for the testing of systemic repeated dose target organ toxicity (RDT), covering liver, kidney, lung and neuronal system as target organs, as well as experimental systems that cover developmental and reproductive toxicity (DART). The project's objective is to assess the application of NAMs as a tool to improve read-across, as well as in the context of ab initio chemical safety assessment.However, multiple non-animal-based test methods have never been formally validated. In order to use such NAMs in the regulatory context, criteria are being brought up in international organizations to define their readiness. In view of this international situation, researchers from Asia are also contributing to development of NAMs. They have come forward to coordinate the development to of NAMs in a regulatory context in their respective countries.
In this Research Topic the Topic Editors intend to spotlight current activities pertaining to NAMs, discovery of newer IVT approaches as well as adoption of the existing and upcoming methods, by Asian researchers. The Topic Editors encourage authors to contribute manuscripts on current activities related to the development of newest NAMs in each country, and also on the adoption of newer methods in their research and regulatory context, e.g. IVT as a multifaceted and multi-dimensional tool, ranging from the simple 2-D flat culture to 3-D culture to organs-on-chip to organoids-on-chip to multi-organ-on-chip to human-on-chip to 3-D printing, as well as stem cell science and all advanced analytical and imaging technologies.