Author : Hans-Dieter Volk
Publisher : Frontiers Media SA
Page : 178 pages
File Size : 23,58 MB
Release : 2022-11-30
Category : Medical
ISBN : 2832507808
Author : Maria Cristina Galli
Publisher : Springer
Page : 235 pages
File Size : 22,62 MB
Release : 2015-09-15
Category : Medical
ISBN : 3319186183
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.
Author : Rakesh Sharma
Publisher : BoD – Books on Demand
Page : 353 pages
File Size : 22,94 MB
Release : 2018-05-02
Category : Science
ISBN : 1789230101
Stem Cells in Clinical Practice and Tissue Engineering is a concise book on applied methods of stem cell differentiation and optimization using tissue engineering methods. These methods offer immediate use in clinical regenerative medicine. The present volume will serve the purpose of applied stem cell differentiation optimization methods in clinical research projects, as well as be useful to relatively experienced stem cell scientists and clinicians who might wish to develop their stem cell clinical centers or research labs further. Chapters are arranged in the order of basic concepts of stem cell differentiation, clinical applications of pluripotent stem cells in skin, cardiac, bone, dental, obesity centers, followed by tissue engineering, new materials used, and overall evaluation with their permitted legal status.
Author : World Health Organization
Publisher :
Page : 0 pages
File Size : 35,4 MB
Release : 2014
Category : Drugs
ISBN : 9789290360841
Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
Author : The Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada
Publisher : Council of Canadian Academies
Page : 122 pages
File Size : 43,55 MB
Release : 2020-11-05
Category : Medical
ISBN : 1926522796
From Research to Reality describes the stages involved in the approval and use of gene therapies in Canada, and examines challenges associated with regulatory oversight, manufacturing, access, and affordability, and identifies promising approaches to address them.
Author :
Publisher :
Page : 199 pages
File Size : 29,29 MB
Release : 2004
Category :
ISBN :
Author : Wojciech Chrzanowski
Publisher : Royal Society of Chemistry
Page : 255 pages
File Size : 29,20 MB
Release : 2021-10-20
Category : Technology & Engineering
ISBN : 1839164565
Extracellular and biofluids vesicles (EVs) are highly specialised yet ubiquitous nanoscale messengers secreted by cells. With the development of stem cell engineering, EVs promise to deliver next generation tools in regenerative medicine and tissue engineering, as well as in diagnostics. A vibrant and promising field, this book provides the first resource to the field. Covering basic cell biology, including EV production and intracellular communication, this book will provide material scientists and engineers with a foundation to the necessary biology. The reader will then learn about the isolation of extracellular vesicles their physicochemical characterisation and therapeutic application of EVs in regenerative medicine as well as their potential as biomarkers in medical diagnostic. This book will also discuss the regulatory landscape of EVs. Bridging cell biology, biomaterials, biophysics and biomedical engineering the content of this book is written with a broad interdisciplinary audience in mind. Researchers, new and established will find this a must-have on their shelf.
Author : Stefania Boccia
Publisher : Springer Nature
Page : 135 pages
File Size : 20,27 MB
Release : 2020-11-23
Category : Medical
ISBN : 3030523993
Practitioners are increasingly adopting a personalised medicine approach to individually tailored patient care, especially disease diagnosis and treatment with the use of biomarkers. However, development and implementation of such approaches to chronic disease prevention need further investigation and concerted efforts for proper use in healthcare systems. This book provides high-quality, multidisciplinary knowledge from research in personalised medicine, specifically personalised prevention of chronic disease. It addresses different perspectives of prevention in the field, and is the outcome of a four-year work of the Personalized prevention of Chronic Disease (PRECeDI) Consortium, a multi-disciplinary and multi-professional team of experts. The Consortium jointly agreed to document and address the five aspects or domains of personalised medicine and prevention as individual chapters: Identification of biomarkers for the prevention of chronic disease Evaluation of predictive genomic applications Ethico-legal and policy issues surrounding personalised medicine Roles and responsibilities of stakeholders in informing healthy individuals on their genome: a sociotechnical analysis Identification of organisational models for the provision of predictive genomic applications The book focuses on the Consortium's recommendations that are derived from each of these domains based on up-to-date evidence and research that the authors write, follow, and systematically organise and report. Personalisation of health care is, eventually, a driver of innovation in research and healthcare systems. With this SpringerBrief on Personalised Health Care: Fostering Precision Medicine Advancements for Gaining Population Health Impact, the Consortium provides further evidence of the clinical validity and utility of personalised medicine with special emphasis on the prevention of chronic diseases. The book is a useful resource for policy makers, industry and healthcare professionals, scientists, technology-sector professionals, investors, citizens, and private companies that need proper advice to realise the potential of personalised medicine.
Author :
Publisher :
Page : 0 pages
File Size : 43,4 MB
Release : 2025
Category :
ISBN : 9783031440823
Author : United Kingdom Blood Transfusion Services
Publisher : Stationery Office
Page : 372 pages
File Size : 38,86 MB
Release : 2005-10-12
Category : Medical
ISBN : 9780117033719
This is the seventh edition of a book that provides best practice guidelines and detailed technical procedures for blood transfusion services. It takes account of the European Directives on blood and tissues and resulting UK regulations and indicates which of the guidelines that are now legal requirements.
