2.4 A Validation Roadmap for Upcoming “Human-on-a-Chip” Solutions
References
Chapter 13: Integrated Approaches to Testing and Assessment
1 Introduction
2 Historical Perspective on IATA
3 The Building Blocks of IATA
4 Development of IATA
5 Validation of IATA
5.1 Emerging Principles for the Evaluation of IATA
5.2 Proposed Stepwise Approach to Evaluation of IATA
6 Examples of IATA
6.1 Skin Irritation and Corrosion
6.2 Skin Sensitisation
6.3 The Threshold of Toxicological Concern (TTC) Approach
6.4 Identification of Endocrine Active Substances
7 Conclusions
References
Chapter 14: International Harmonization and Cooperation in the Validation of Alternative Methods
1 Introduction
2 Creation and Purpose of the International Cooperation on Alternative Methods (ICATM)
3 Mapping of ICATM Partner Organizations’ Functioning: Mandate, Legislative Context, Drivers, Structure and Workflow
3.1 The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM)
3.2 The U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the U.S. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
3.3 Health Canada
3.4 The Japanese Center for the Validation of Alternative Methods (JaCVAM)
3.5 The Korean Center for the Validation of Alternative Methods (KoCVAM)
3.6 Points in Common and Differences Between the Different ICATM Organizations
4 Recent Developments in Countries with Observer Status at ICATM
4.1 Brazil
4.2 China
4.2.1 Status of Training and Acceptance of OECD Test Guidelines on Alternative Methods
4.2.2 New Investment in the Twenty-First Century Safety Sciences
4.2.3 Challenges Ahead and Future Opportunities
5 Strengthening International Harmonization and Cooperation on the Validation and Acceptance of Alternative Methods
5.1 Test Method Selection/Prioritization
5.2 Conducting Validation Studies
5.3 Validation Laboratory Networks
5.4 Conducting Peer Reviews
5.5 Test Method Recommendations
5.6 Dissemination and Communication
5.7 International Programmes and Regulatory Acceptance
6 Concluding Remarks
References
Chapter 15: Evolving the Principles and Practice of Validation for New Alternative Approaches to Toxicity Testing