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In Vivo Modeling

In Vivo Modeling. James Swick, PhD CSO LyChron, LLC. In Vitro vs. In Vivo Studies. Device application Target organ system Intended treatment Expected outcome The model The in vivo study. Device Application. Purpose of the device. Who is expected to use the device?

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In Vivo Modeling

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  1. In Vivo Modeling James Swick, PhD CSO LyChron, LLC J. Swick, PhD LyChron, LLC

  2. In Vitro vs. In Vivo Studies • Device application • Target organ system • Intended treatment • Expected outcome • The model • The in vivo study J. Swick, PhD LyChron, LLC

  3. Device Application • Purpose of the device. • Who is expected to use the device? • Method of application. • Ergonomics J. Swick, PhD LyChron, LLC

  4. Target Organ System • Cardiovascular • Gastrointestinal • Urinary/Reproductive • Musculoskeletal • Respiratory • Central Nervous System • Ophthalmic J. Swick, PhD LyChron, LLC

  5. Expected Outcome • What is your intention? • What is the intended effect? • What complications may arise from your application? J. Swick, PhD LyChron, LLC

  6. Intended Treatment • Identify anatomical and physiological constraints. • Device deployment/application issues. J. Swick, PhD LyChron, LLC

  7. The Model • What have others used? • What was their experience? • How can you avoid other’s pitfalls? J. Swick, PhD LyChron, LLC

  8. In Vivo Study • Study design • Available resources • Where to perform the research • Pilot study vs. data for submission J. Swick, PhD LyChron, LLC

  9. Acute Study Initial/pilot study Developmental stage Evaluate biological requirements Chronic Study Biocompatibility Evaluate long-term effects Establish requirements for transition to clinical trials Acute vs. Chronic J. Swick, PhD LyChron, LLC

  10. The Procedure • Surgical vs. medical • Minimally invasive vs. open • Catheter based J. Swick, PhD LyChron, LLC

  11. The Lab • Experience of the technical staff • Professional support • Regulatory compliance and resources • Track record • Available resources J. Swick, PhD LyChron, LLC

  12. Regulatory • USDA - Animal Welfare Act • FDA - 21CFR part 58 • DEA • NRC • PHS • OSHA J. Swick, PhD LyChron, LLC

  13. The Launch J. Swick, PhD LyChron, LLC

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