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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - Proceedings of a Workshop (Paperback)
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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - Proceedings of a Workshop (Paperback)
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The emerging multidisciplinary field of regenerative engineering is
devoted to the repair, regeneration, and replacement of damaged
tissues or organs in the body. To accomplish this it uses a
combination of principles and technologies from disciplines such as
advanced materials science, developmental and stem cell biology,
immunology, physics, and clinical translation. The term
"regenerative engineering" reflects a new understanding of the use
of tissue engineering for regeneration and also the growing number
of research and product development efforts that incorporate
elements from a variety of fields. Because regenerative engineered
therapies rely on live cells and scaffolds, there are inherent
challenges in quality control arising from variability in source
and final products. Furthermore, each patient recipient, tissue
donor, and product application is unique, meaning that the field
faces complexities in the development of safe and effective new
products and therapies which are not faced by developers of more
conventional therapies. Understanding the many sources of
variability can help reduce this variability and ensure consistent
results. The Forum on Regenerative Medicine hosted a public
workshop on October 18, 2018, in Washington, DC, to explore the
various factors that must be taken into account in order to develop
successful regenerative engineering products. Invited speakers and
participants discussed factors and sources of variability in the
development and clinical application of regenerative engineering
products, characteristics of high-quality products, and how
different clinical needs, models, and contexts can inform the
development of a product to improve patient outcomes. This
publication summarizes the presentation and discussion of the
workshop. Table of Contents Front Matter 1 Introduction and
Overview 2 Sources of Variability Associated with Regenerative
Therapies: Lessons from Case Studies 3 Factors Contributing to
Patient Variability 4 Addressing Variability in Donor Tissues and
Cells 5 Addressing Variability and Meeting Quality Expectations in
the Manufacturing Setting 6 Exploring Variability and Its Impact on
Product Regulation and Outcomes 7 Potential Next Steps to Consider
for Addressing Variability References Appendix A: Workshop Agenda
Appendix B: Speaker Biographical Sketches Appendix C: Statement of
Task Appendix D: Registered Attendees
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