ILSI HESI DART Workshop: Fetal Imaging in Regulatory Development Toxicity Studies

ILSI HESI DART April 2015.png


Abstract:  Developing and using specific imaging technologies (e.g., micro-CT, MRI) allow for alternative methods for evaluating structural birth defects in animal models.  As the technology develops increased capabilities and speed, this technique could eventually become a high-throughput method and allow for sharing of images between laboratories and regulatory agencies.  In practice, it will eliminate the use of large quantities of processing chemicals and wet-specimen archives.  At this time, the technical methods, the alterations observed, and their interpretation have not yet gained general regulatory acceptance.  In order to facilitate acceptance, a set of criteria will be developed that would help organizations validate their individual imaging systems and provide the basis for acceptance of these technologies by the regulatory community.

This workshop aims to:

1.     Introduce and discuss image capture technology relative to existing fetal evaluation methodology;

2.     Understand the regulatory community’s perspective and path for acceptance of results using imaging technology;

3.     Discuss minimal acceptable criteria for imaging to comply with Good Laboratory Practices and Computer Validations requirements; and

4.     Develop criteria to demonstrate concordance between new and existing examination methods and between testing results.

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