Developing Integrated Approaches for Testing and Assessment (IATAs) in order to support nanomaterial safety

Area of Science:

• Biomedical Engineering
• Materials Science
• Toxicology

Background:

• Nanomaterials (NM) offer unique properties for nanomedicines and medical devices (MD), but comprehensive safety data is often lacking.
• Gaps in understanding NM-induced toxicity mechanisms hinder the safety assessment required for MD applications.
• Current regulatory pathways may not fully address the specific characteristics of NMs.

Purpose of the Study:

• To provide guidance for implementing pre-clinical safety assessment strategies for nanomaterials (NM).
• To facilitate the translation of NM-based innovations from research to clinical application.
• To develop a framework for tailored safety evaluations considering NM-specific properties.

Main Methods:

• Utilizing Integrated Approaches to Testing and Assessment (IATAs) as a key tool.
• Employing an iterative approach to gather information from existing data, in silico models, and new experimental protocols.
• Developing an example IATA specifically for assessing the hemocompatibility of NMs intended for direct blood contact.

Main Results:

• The proposed IATA framework integrates current NM safety assessment guidelines.
• It provides a structured approach for information and data gathering for intravenously injected NMs.
• The developed decision framework is adaptable for other testing needs and regulatory contexts.

Conclusions:

• IATAs offer a tailored strategy to address safety assessment challenges for nanomaterials (NM).
• This approach supports regulatory compliance while accounting for NM-specific considerations.
• The developed framework enhances the potential for successful clinical translation of nanomedicines and MDs.