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The Effective Design & Development of Preclinical Studies

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Within the medical device development industry, preclinical studies are on the rise as medical technologies become progressively complex. While biocompatibility testing is required for novel devices, biological effects can increasingly be addressed by pairing materials characterization with risk assessment activities. However, the assessment of critical preclinical endpoints are often only achievable through the utilization of in vivo studies, and preclinical studies are typically required to address more complex effects such as implantability, usability, and overall safety. Therefore, it is critical that global medical device manufacturers understand how to effectively develop and design customized studies to achieve successful preclinical study outcomes.

This NAMSA webinar, presented by Dr. Joseph Carraway (NAMSA’s Scientific Director of Laboratory Services), will provide information that draws upon the U.S. Food & Drug Administration’s (FDA) Guidance Document on “General Considerations for Animal Studies for Medical Devices” (issued in 2015), and will provide a better understanding of:

  • Key questions to ask during the initial stage of preclinical study development, including purpose, objectives, and endpoints
  • The FDA’s guidance on how to best determine model selection
  • Considerations for optimizing group sizes
  • How to identify ‘needs’ versus ‘wants,’ and when combining the two can become problematic
  • Development of secondary endpoints
  • Determination of guidance documents or standards to follow
  • The utilization of the FDA’s Pre-Submission Program to receive preclinical study feedback
  • The importance of active communication between a study sponsor and laboratory

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