Guide to Cell Therapy GxP Book

Guide to Cell Therapy GxP


  • Author : Joaquim Vives
  • Publisher : Academic Press
  • Release Date : 2015-07-30
  • Genre: Uncategoriezed
  • Pages : 266
  • ISBN 10 : 0128031158

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Guide to Cell Therapy GxP Excerpt :

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.

Guide to Cell Therapy GxP Book

Guide to Cell Therapy GxP


  • Author : Joaquim Vives
  • Publisher : Academic Press
  • Release Date : 2015-07-24
  • Genre: Medical
  • Pages : 266
  • ISBN 10 : 9780128031162

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Guide to Cell Therapy GxP Excerpt :

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

Research Methods for Student Radiographers Book

Research Methods for Student Radiographers


  • Author : Christopher M. Hayre
  • Publisher : CRC Press
  • Release Date : 2021-09-28
  • Genre: Medical
  • Pages : 193
  • ISBN 10 : 9781000454345

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Research Methods for Student Radiographers Excerpt :

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 p

Regulatory Aspects of Gene Therapy and Cell Therapy Products Book

Regulatory Aspects of Gene Therapy and Cell Therapy Products


  • Author : Maria Cristina Galli
  • Publisher : Springer
  • Release Date : 2015-09-15
  • Genre: Medical
  • Pages : 230
  • ISBN 10 : 9783319186184

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Regulatory Aspects of Gene Therapy and Cell Therapy Products Excerpt :

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.

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Book

Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy


  • Author : Mahmoud Aljurf
  • Publisher : Springer Nature
  • Release Date : 2021-02-19
  • Genre: Medical
  • Pages : 181
  • ISBN 10 : 9783030644925

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Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Excerpt :

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.

Cell and Gene Therapies Book

Cell and Gene Therapies


  • Author : Miguel-Angel Perales
  • Publisher : Springer
  • Release Date : 2018-11-27
  • Genre: Medical
  • Pages : 288
  • ISBN 10 : 9783319543680

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Cell and Gene Therapies Excerpt :

In 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.

Good Research Practice in Non Clinical Pharmacology and Biomedicine Book

Good Research Practice in Non Clinical Pharmacology and Biomedicine


  • Author : Anton Bespalov
  • Publisher : Springer Nature
  • Release Date : 2020-01-01
  • Genre: Cardiology
  • Pages : 424
  • ISBN 10 : 9783030336561

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Good Research Practice in Non Clinical Pharmacology and Biomedicine Excerpt :

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.

Perinatal Stem Cells Book

Perinatal Stem Cells


  • Author : Anthony Atala
  • Publisher : Academic Press
  • Release Date : 2018-06-14
  • Genre: Science
  • Pages : 418
  • ISBN 10 : 9780128120637

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Perinatal Stem Cells Excerpt :

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

Guide to the Quality and Safety of Tissues and Cells for Human Application Book

Guide to the Quality and Safety of Tissues and Cells for Human Application


  • Author : European Directorate for the Quality of Medicines & Healthcare
  • Publisher : Unknown
  • Release Date : 2013-10-11
  • Genre: Cell transplantation
  • Pages : 320
  • ISBN 10 : 9287176396

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Guide to the Quality and Safety of Tissues and Cells for Human Application Excerpt :

This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types

Regulated Bioanalysis  Fundamentals and Practice Book

Regulated Bioanalysis Fundamentals and Practice


  • Author : Mario L. Rocci Jr.
  • Publisher : Springer
  • Release Date : 2017-04-24
  • Genre: Medical
  • Pages : 230
  • ISBN 10 : 9783319548029

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Regulated Bioanalysis Fundamentals and Practice Excerpt :

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

Good Quality Practice  GQP  in Pharmaceutical Manufacturing  A Handbook Book

Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook


  • Author : Jordi Botet
  • Publisher : Bentham Science Publishers
  • Release Date : 2015-09-28
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781681081144

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Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook Excerpt :

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Registries for Evaluating Patient Outcomes Book

Registries for Evaluating Patient Outcomes


  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher : Government Printing Office
  • Release Date : 2014-04-01
  • Genre: Medical
  • Pages : 356
  • ISBN 10 : 9781587634338

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Registries for Evaluating Patient Outcomes Excerpt :

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Cellular Transplantation Book

Cellular Transplantation


  • Author : Craig Halberstadt
  • Publisher : Elsevier
  • Release Date : 2011-10-10
  • Genre: Science
  • Pages : 696
  • ISBN 10 : 9780080469041

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Cellular Transplantation Excerpt :

There have been tremendous strides in cellular transplantation in recent years, leading to accepted practice for the treatment of certain diseases, and use for many others in trial phases. The long history of cellular transplantation, or the transfer of cells from one organism or region of the body to another, has been revolutionized by advances in stem cell research, as well as developments in gene therapy. Cellular Transplants: From Lab to Clinic provides a thorough foundation of the basic science underpinning this exciting field, expert overviews of the state-of-the-art, and detailed description of clinical success stories to date, as well as insights into the road ahead. As highlighted by this timely and authoritative survey, scale-up technologies and whole organ transplantation are among the hurdles representing the next frontier. The contents are organized into four main sections, with the first covering basic biology, including transplant immunology, the use of immunosuppressive drugs, stem cell biology, and the development of donor animals for transplantation. The next part looks at peripheral and reconstructive applications, followed by a section devoted to transplantation for diseases of the central nervous system. The last part presents efforts to address the key challenges ahead, such as identifying novel transplantable cells and integrating biomaterials and nanotechnology with cell matrices. Provides detailed description of clinical trials in cell transplantation Review of current therapeutic approaches Coverage of the broad range of diseases addressed by cell therapeutics Discussion of stem cell biology and its role in transplantation