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Author: Joaquim Vives Publisher: Academic Press ISBN: 0128031166 Category : Medical Languages : en Pages : 266
Book Description
Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards
Author: Joaquim Vives Publisher: Academic Press ISBN: 0128031166 Category : Medical Languages : en Pages : 266
Book Description
Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards
Author: Luis Romero Publisher: Createspace Independent Publishing Platform ISBN: 9781985890183 Category : Languages : en Pages : 354
Book Description
The book is about you.Traditional healthcare sometimes doesn't respond to specific needs and thus you may feel the need to explore & find a way to improve your quality of life. When you have a simple flu or a minor infection, following the rules of your local health system, your insurance procedures, or friends advice might not work. It's time to take responsibility over your own health. Even if it means getting educated on overseas options, emerging techniques and groundbreaking research.This book explains, in a simple language, the scope of Stem Cell therapies, the realistic expectations, as well as different forms of SCT, so that you can make an informed decision if this type of therapy is right for you.
Author: Mahmoud Aljurf Publisher: Springer Nature ISBN: 3030644928 Category : Medical Languages : en Pages : 181
Book Description
This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.
Author: Maria Cristina Galli Publisher: Springer Nature ISBN: 3031345673 Category : Science Languages : en Pages : 243
Book Description
This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. 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 and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, 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 & 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: Christopher M. Hayre Publisher: CRC Press ISBN: 1000454347 Category : Medical Languages : en Pages : 193
Book Description
This book provides an holistic picture of the application of research in radiography and focuses on multivariant methodological approaches and practices. It will provide readers insight into both contemporary and innovative methods within radiography research, backed up with evidence-based literature. This book may also be translated into other health disciplines as it introduces research to the reader by detailing terms that can often be confusing for students. These remain central in understanding the importance of research in radiography and how the generation of new knowledge is obtained. This will be supported with subsequent chapters concerning the literature, formation of research questions and detail the early beginnings of a research proposal. Chapters will include a wide range of topics, such as quantitative and qualitative methodologies and data collection tools pertinent to radiographic research, whilst discussing data analysis and need for rigor. The authors draw from our experiences, published outputs and clinical work, supported with alternate philosophies and methods used in diagnostic radiography. Each chapter will examine the multifaceted use and application of each ‘sub-theme’ pertinent to research in radiography, which is presented in a single text for students and, perhaps, practitioners. The targeted audience for this book is interdisciplinary but clearly focuses on those studying undergraduate radiography in response to the limited texts available. We also anticipate it to provide a useful tool for academics delivering undergraduate radiography programmes and those supporting postgraduate research. The key features will: • explore important research approaches and concepts within diagnostic radiography • provide contemporary evidence-based practice regarding mixed method approaches • provide a ‘how to guide’ for understanding key research principles in a wide range of radiographic settings • evaluate the impact of research on patients and the radiographer–patient relationship Dr. Christopher Hayre is a Senior Lecturer in Diagnostic Radiography at Charles Sturt University in New South Wales, Australia. Dr. Xiaoming Zheng has been teaching medical radiation science courses at Charles Sturt University since 1998.
Author: Jorge S. Burns Publisher: Springer Nature ISBN: 3031300408 Category : Science Languages : en Pages : 226
Book Description
This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. —Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology
Author: Anton Bespalov Publisher: Springer Nature ISBN: 3030336565 Category : Cardiology Languages : en Pages : 424
Book Description
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Author: George P. Patrinos Publisher: Academic Press ISBN: 0128136960 Category : Science Languages : en Pages : 406
Book Description
Applied Genomics and Public Health examines the interdisciplinary and growing area of how evidence-based genomic knowledge can be applied to public health, population health, healthcare and health policies. The book gathers experts from a variety of disciplines, including life sciences, social sciences, and health care to develop a comprehensive overview of the field. In addition, the book delves into subjects such as pharmacogenomics, genethics, big data, data translation and analysis, economic evaluation, genomic awareness and education, sociology, pricing and reimbursement, policy measures and economic evaluation in genomic medicine. This book is essential reading for researchers and students exploring applications of genomics to population and public health. In addition, it is ideal for those in the biomedical sciences, medical sociologists, healthcare professionals, nurses, regulatory bodies and health economists interested in learning more about this growing field. Explores the growing application of genomics to population and public health Features internationally renowned contributors from a variety of related fields Contains chapters on important topics such as genomic data sharing, genethics and public health genomics, genomics and sociology, and regulatory aspects of genomic medicine and pharmacogenomics
Author: Anthony Atala Publisher: Academic Press ISBN: 0128120630 Category : Science Languages : en Pages : 418
Book Description
Perinatal Stem Cells provides researchers and clinicians with a comprehensive description of the current clinical and pre-clinical applications of stem cells derived from perinatal sources, such as amniotic fluid, placenta and placental membranes, the umbilical cord and Wharton’s jelly. It's compiled by leading experts in the field, offering readers detailed insights into sources of perinatal stem cells and their potential for disease treatment. Therapeutic applications of perinatal stem cells include the treatment of in utero and pregnancy related diseases, cardiac disease, liver disease, pulmonary disease, inflammatory diseases, for hematopoietic regeneration, and for neural protection after stroke or traumatic brain injury. In addition, the rapid advance in clinical translation and commercialization of perinatal stem cell therapies is highlighted in a section on Clinical and Industry Perspective which provides insight into the new opportunities and challenges involved in this novel and exciting industry. Explores current clinical and pre-clinical application of stem cells derived from perinatal sources Offers detailed insight into sources of perinatal stem cells and their potential for disease treatment Discusses progress in the manufacturing, banking and clinical translation of perinatal stem cells Edited by a world-renowned team to present a complete story of the development and promise of perinatal stem cells
Author: Joaquim Vives
Author: Joaquim Vives
Author: Luis Romero
Author: Mahmoud Aljurf
Author: Maria Cristina Galli
Author: Christopher M. Hayre
Author: Minal Ghante
Author: Jorge S. Burns
Author: Anton Bespalov
Author: George P. Patrinos
Author: Anthony Atala