Toxicologic pathology plays a critical role in drug development, yet its intersection with digital pathology is often overlooked. As a veterinary pathologist, I want to shed light on this important application.
This is Chapter 5 of the "Digital Pathology 101" book and in this chapter, you will learn how whole slide imaging is transforming preclinical trials. I'll explain key concepts like creating faithful digital replicas of glass slides. We'll also dive into validations needs for digital systems in regulated GLP studies.
Whole Slide Imaging Overview
I'll start by explaining whole slide imaging. This technology creates 2D digital copies of glass slides. The focus is not 3D images, but flat digital images containing the visual information pathologists need for analysis and reporting.
The FDA states these digital images can substitute for glass slides in preclinical toxicity studies, provided they meet requirements as "faithful digital replicas." With proper validations, digital slides enable remote assessments for multisite trials.
Validation and Documentation
For regulated GLP studies, replacing glass slides necessitates validating the whole digital pathology system. This includes IT infrastructure, scanners, software and more based on intended use.
Documentation is also key. Peer review statements should note the use of digital slides. Images must be securely stored and transmitted to maintain raw data integrity.
Conclusion
In closing, the FDA's guidance on digital pathology in preclinical trials signals an important step towards regulatory acceptance. Digital tools promise more controlled, efficient toxicity assessments, ultimately advancing drug development.
This chapter provides a compass for teams navigating digital pathology in regulated environments. Understanding principles of validation, security, and transparency allows us to realize the benefits while ensuring high standards.
You can find the original FDA guidance document this chapter is based on here:
Or you can watch me explain the guidelines here:
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