Explore how early integration of toxicologic pathology can improve medical device safety, reduce miscommunication, and strengthen regulatory outcomes in device development.
Explore how early integration of toxicologic pathology can improve medical device safety, reduce miscommunication, and strengthen regulatory outcomes in device development.
Learn how integrating toxicologic pathology best practices into medical device evaluation can improve biological assessment, strengthen regulatory outcomes, and reduce study risk.
The road to bringing a medical device to market is fraught with potential regulatory pitfalls and decisions that can delay—or even derail—your efforts.
Learn how StageBio uses Tissue Cross Reactivity studies (TCR) and how it helps clinical researchers when identifying off target binding.
When it comes to preclinical research and clinical trials, the logistics outside the lab are as crucial as the processes and handling of samples inside the lab. In other words, frozen samples must be handled with care and transported in a timely manner to make sure project milestones are reached.
Products such as cytotoxic chemotherapeutics and AAV-based gene therapies are associated with gangliotoxicity. Despite this, prior toxicology guidance provided no recommendations for which sensory and autonomic ganglia to evaluate in nonclinical general toxicity studies.
Good Laboratory Practices (GLP) refers to a system where non-clinical health and safety studies are carried out, planned, monitored, recorded, archived and reported.
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