Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Preclinical evaluation of prototype products.

J C Park1, D H Lee, H Suh

  • 1Department of Medical Engineering, Yonsei University College of Medicine, Seoul, Korea.

Yonsei Medical Journal
|February 8, 2000
PubMed
Summary

Preclinical evaluation assesses medical device safety and efficacy before human use. This involves studying biomaterial interactions, host responses, and degradation for safe clinical application.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Outcome evaluation of carotid stenting in high-risk patients with symptomatic carotid near occlusion.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences·2010
Same author

The α-isoform of class II phosphoinositide 3-kinase is necessary for the activation of ERK but not Akt/PKB.

Molecular and cellular biochemistry·2010
Same author

Variation in 8-ketotrichothecenes and zearalenone production by Fusarium graminearum isolates from corn and barley in Korea.

Mycopathologia·2010
Same author

Physiology and Clinical Medicine: Bridging the Gap.

British medical journal·2010
Same author

Optimal timing of G-CSF administration for effective autologous stem cell collection.

Bone marrow transplantation·2010
Same author

Immunoglobulin D multiple myeloma: response to therapy, survival, and prognostic factors in 75 patients.

Annals of oncology : official journal of the European Society for Medical Oncology·2010

Area of Science:

  • Biomaterials Science
  • Medical Device Engineering
  • Translational Medicine

Background:

  • Preclinical evaluation is crucial for assessing prototype medical devices and their materials.
  • It ensures the efficacy, safety, and biocompatibility of biomaterials and prostheses.
  • Understanding in vivo interactions and host effects is key to device safety.

Purpose of the Study:

  • To investigate the intended use of medical device materials through preclinical evaluation.
  • To determine the efficacy, safety, and biocompatibility of biomaterials and medical devices.
  • To assess the potential harm of a material to humans by evaluating its interaction with the in vivo environment.

Main Methods:

  • Materials science and engineering analysis.
  • Biological and biochemical testing.
  • Evaluation of host reactions and material degradation in a biological environment.

Main Results:

  • Preclinical data provides insights into material-host interactions.
  • Safety testing identifies potential harm to humans.
  • The evaluation determines the prototype product's performance and host response.

Conclusions:

  • Preclinical evaluation is essential for determining the safety and efficacy of medical devices.
  • Comprehensive data including material science, biology, and host response is required.
  • This evaluation ensures appropriate host response for specific clinical applications.

Related Experiment Videos