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Author: Hans-Dieter Volk
Publisher: Frontiers Media SA
Published: 2022-11-30
Total Pages: 178
ISBN-13: 2832507808
DOWNLOAD EBOOKAuthor: Maria Cristina Galli
Publisher: Springer
Published: 2015-09-15
Total Pages: 235
ISBN-13: 3319186183
DOWNLOAD EBOOKThis 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
Published: 2018-05-02
Total Pages: 353
ISBN-13: 1789230101
DOWNLOAD EBOOKStem 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:
Published: 2014
Total Pages: 0
ISBN-13: 9789290360841
DOWNLOAD EBOOKRisk 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
Published: 2020-11-05
Total Pages: 122
ISBN-13: 1926522796
DOWNLOAD EBOOKFrom 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:
Published: 2004
Total Pages: 199
ISBN-13:
DOWNLOAD EBOOKAuthor: Wojciech Chrzanowski
Publisher: Royal Society of Chemistry
Published: 2021-10-20
Total Pages: 255
ISBN-13: 1839164565
DOWNLOAD EBOOKExtracellular 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:
Publisher:
Published: 2025
Total Pages: 0
ISBN-13: 9783031440823
DOWNLOAD EBOOKAuthor: United Kingdom Blood Transfusion Services
Publisher: Stationery Office
Published: 2005-10-12
Total Pages: 372
ISBN-13: 9780117033719
DOWNLOAD EBOOKThis 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.
Author: Miguel-Angel Perales
Publisher: Springer
Published: 2018-11-27
Total Pages: 286
ISBN-13: 3319543687
DOWNLOAD EBOOKIn this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee.
