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Sensitization testing is designed to rule out the potential for allergic reactions that can result from exposure to a medical device, material, or pharmaceutical product. These delayed hypersensitivity reactions can occur when the body’s immune system identifies a...

In today’s dynamic regulatory and supply chain landscape, more medical device and pharmaceutical manufacturers are exploring changes to their sterilization methods. These shifts are often driven by growing environmental concerns, evolving regulatory expectations, and...

New Approach Methodologies (NAMs)—ranging from in vitro assays to computational models—offer promising alternatives to traditional animal testing. However, their widespread adoption hinges on confidence in their predictive power. Integrating diverse data sources such...