Pre-clinical Safety Assessment of Tissue Engineered Medical Products (TEMPs)
Author : E. A. E. van Tienhoven
Publisher :
Page : 33 pages
File Size : 36,55 MB
Release : 2001
Category :
ISBN :
Tissue Engineered Medical Products (TEMPs)
Author : Eliane Schutte
Publisher : ASTM International
Page : 267 pages
File Size : 29,18 MB
Release : 2004
Category : Biomedical materials
ISBN : 0803134711
Book Description
Written by an international group of industry experts, regulators, and academics, this new ASTM publication provides the latest data on tissue engineering and the standards available for manufacturing TEMPs. Twenty-three peer-reviewed papers cover current technology, existing standards, development of new standards, and international standards used by regulatory bodies.
Tissue Engineered Medical Products (TEMPs): a Prelude to Risk Management
Author : C. Wassenaar
Publisher :
Page : 57 pages
File Size : 21,15 MB
Release : 2001
Category :
ISBN :
Book Description
Modern Methods of Clinical Investigation
Author : Institute of Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 35,94 MB
Release : 1990-02-01
Category : Medical
ISBN : 0309042860
Book Description
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Regulatory Aspects of Gene Therapy and Cell Therapy Products
Author : Maria Cristina Galli
Publisher : Springer
Page : 235 pages
File Size : 44,3 MB
Release : 2015-09-15
Category : Medical
ISBN : 3319186183
Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Infant Formula
Author : Institute of Medicine
Publisher : National Academies Press
Page : 220 pages
File Size : 17,8 MB
Release : 2004-06-10
Category : Medical
ISBN : 0309185505
Book Description
Infant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. They are critical to infant health since they must safely support growth and development during a period when the consequences on inadequate nutrition are most severe. Existing guidelines and regulations for evaluating the safety of conventional food ingredients (e.g., vitamins and minerals) added to infant formulas have worked well in the past; however they are not sufficient to address the diversity of potential new ingredients proposed by manufacturers to develop formulas that mimic the perceived and potential benefits of human milk. This book, prepared at the request of the Food and Drug Administration (FDA) and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of new ingredients to infants.
Stem-Cell Nanoengineering
Author : H. Baharvand
Publisher : John Wiley & Sons
Page : 438 pages
File Size : 15,91 MB
Release : 2015-03-30
Category : Science
ISBN : 1118540611
Book Description
Stem Cell Nanoengineering reviews the applications of nanotechnology in the fields of stem cells, tissue engineering, and regenerative medicine. Topics addressed include various types of stem cells, underlying principles of nanobiotechnology, the making of nano-scaffolds, nano tissue engineering, applications of nanotechnology in stem cell tracking and molecular imaging, nano-devices, as well as stem cell nano-engineering from bench to bedside. Written by renowned experts in their respective fields, chapters describe and explore a wide variety of topics in stem cell nanoengineering, making the book a valuable resource for both researchers and clinicians in biomedical and bioengineering fields.
Frontiers in Tissue Engineering
Author : C.W. Patrick
Publisher : Elsevier
Page : 717 pages
File Size : 41,40 MB
Release : 1998-02-20
Category : Technology & Engineering
ISBN : 0080532055
Book Description
Frontiers in Tissue Engineering is a carefully edited compilation of state-of-the-art contributions from an international authorship of experts in the diverse subjects that make up tissue engineering. A broad representation of the medical, scientific, industrial and regulatory community is detailed in the book. The work is an authoritative and comprehensive reference source for scientists and clinicians working in this emerging field. The book is divided into three parts: fundamentals and methods of tissue engineering, tissue engineering applied to specialised tissues, and tissue engineering applied to organs. The text offers many novel approaches, including a detailed coverage of cell-tissue interactions at cellular and molecular levels; cell-tissue surface, biochemical, and mechanical environments; biomaterials; engineering design; tissue-organ function; new approaches to tissue-organ regeneration and replacement of function; ethical considerations of tissue engineering; and government regulation of tissue-engineered products.
Bone Tissue Engineering
Author : Jeffrey O. Hollinger
Publisher : CRC Press
Page : 462 pages
File Size : 28,13 MB
Release : 2004-10-14
Category : Medical
ISBN : 1135501912
Book Description
Focusing on bone biology, Bone Tissue Engineering integrates basic sciences with tissue engineering. It includes contributions from world-renowned researchers and clinicians who discuss key topics such as different models and approaches to bone tissue engineering, as well as exciting clinical applications for patients. Divided into four sections, t
Advances In Tissue Engineering
Author : Julia M Polak
Publisher : World Scientific
Page : 947 pages
File Size : 38,38 MB
Release : 2008-08-20
Category : Science
ISBN : 1908978902
Book Description
Advances in Tissue Engineering is a unique volume and the first of its kind to bring together leading names in the field of tissue engineering and stem cell research. A relatively young science, tissue engineering can be seen in both scientific and sociological contexts and successes in the field are now leading to clinical reality. This book attempts to define the path from basic science to practical application. A contribution from the UK Stem Cell Bank and opinions of venture capitalists offer a variety of viewpoints, and exciting new areas of stem cell biology are highlighted. With over fifty stellar contributors, this book presents the most up-to-date information in this very topical and exciting field./a
