Regulatory Aspects Of Gene Therapy And Cell Therapy Products PDF Download
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| Author | : Maria Cristina Galli |
| Publisher | : Springer |
| Total Pages | : 235 |
| Release | : 2015-09-15 |
| Genre | : Medical |
| ISBN | : 3319186183 |
Download Regulatory Aspects of Gene Therapy and Cell Therapy Products Book in PDF, ePub and Kindle
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 | : Maria Cristina Galli |
| Publisher | : |
| Total Pages | : |
| Release | : 2015 |
| Genre | : |
| ISBN | : 9783319186191 |
Download Regulatory Aspects of Gene Therapy and Cell Therapy Products Book in PDF, ePub and Kindle
Medical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent--there are no "breastfeeding doctors" who are specifically trained to understand this complex and interactive process. While much of the literature about breastfeeding describes how it "should" work, there is currently nothing available to explain why it often fails and how to treat it. Clinician's Guide to Breastfeeding: Evidence-based Evaluation and Management is written for health care practitioners who work with breastfeeding mothers; physicians, nurses, nurse practitioners, and lactation consultants. It provides clear information and clinically tested strategies to help professionals guide new mothers to breastfeed successfully. The first of its kind to consider the entirety of the breastfeeding experience, Clinician's Guide to Breastfeeding is written by Dr. Linda D. Dahl, a leading expert on the subject. It is a comprehensive review of breastfeeding, covering objective analyses of ideal or "normal" nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process.
| Author | : Avery McIntosh |
| Publisher | : Chapman & Hall/CRC Biostatistics Series |
| Total Pages | : 0 |
| Release | : 2024-03-13 |
| Genre | : |
| ISBN | : 9781032136554 |
Download Development of Gene Therapies Book in PDF, ePub and Kindle
Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development.
| Author | : Clévio Nóbrega |
| Publisher | : Springer Nature |
| Total Pages | : 195 |
| Release | : 2020-06-27 |
| Genre | : Medical |
| ISBN | : 3030413330 |
Download A Handbook of Gene and Cell Therapy Book in PDF, ePub and Kindle
This is a reference handbook for young researchers exploring gene and cell therapy. Gene therapy could be defined as a set of strategies modifying gene expression or correcting mutant/defective genes through the administration of DNA (or RNA) to cells, in order to treat disease. Important advances like the discovery of RNA interference, the completion of the Human Genome project or the development of induced pluripotent stem cells (iPSc) and the basics of gene therapy are covered. This is a great book for students, teachers, biomedical researchers delving into gene/cell therapy or researchers borrowing skills from this scientific field.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 127 |
| Release | : 2020-08-27 |
| Genre | : Medical |
| ISBN | : 0309672988 |
Download Exploring Novel Clinical Trial Designs for Gene-Based Therapies Book in PDF, ePub and Kindle
Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.
| Author | : Adrian Gee |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 258 |
| Release | : 2009-09-18 |
| Genre | : Science |
| ISBN | : 0387895841 |
Download Cell Therapy Book in PDF, ePub and Kindle
Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.
| Author | : Nancy Smyth Templeton |
| Publisher | : CRC Press |
| Total Pages | : 1154 |
| Release | : 2008-10-06 |
| Genre | : Science |
| ISBN | : 084938799X |
Download Gene and Cell Therapy Book in PDF, ePub and Kindle
Since the publication of the second edition of this book in 2004, gene therapy and cell therapy clinical trials have yielded some remarkable successes and some disappointing failures. Now in its third edition, Gene and Cell Therapy: Therapeutic Mechanisms and Strategies assembles many of the new technical advances in gene delivery, clinical applications, and new approaches to the regulation and modification of gene expression. New Topics Covered in this Edition: Gene and Cell Therapies for Diabetes and Cardiovascular Diseases Clinical Trials Human Embryonic Stem Cells Tissue Engineering Combined with Cell Therapies Novel Polymers Relevant Nanotechnologies SiRNA Therapeutic Strategies Dendrimer Technologies Comprised of contributions from international experts, this book begins with a discussion of delivery systems and therapeutic strategies, exploring retroviral vectors and adenovirus vectors, as well as other therapeutic strategies. The middle section focuses on gene expression and detection, followed by an examination of various therapeutic strategies for individual diseases, including hematopoietic disorders, cardiovascular conditions, cancer, diabetes, cystic fibrosis, neurological disorders, and childhood-onset blindness. The final section discusses recent clinical trials and regulatory issues surrounding the new technology. This compendium is assembled by noted molecular biologist and biochemist Nancy Smyth Templeton. Baylor College of Medicine and several other institutions have used Dr. Templeton’s non-viral therapeutics in clinical trials for the treatment of lung, breast, head and neck, and pancreatic cancers, as well as Hepatitis B and C. She continues to work at the forefront of research in gene and cell therapies. Her contributions, as well as those contained in this volume, are sure to advance the state of the art of these revolutionary life-saving technologies.
| Author | : Nancy Smyth Templeton |
| Publisher | : CRC Press |
| Total Pages | : 894 |
| Release | : 2003-12-17 |
| Genre | : Science |
| ISBN | : 0824758609 |
Download Gene and Cell Therapy Book in PDF, ePub and Kindle
This reference is completely revised and expanded to reflect the most critical studies, controversies, and technologies impacting the medical field, including probing research on lentivirus, gutless adenovirus, bacterial and baculovirus vectors, retargeted viral vectors, in vivo electroporation, in vitro and in vivo gene detection systems, and all inducible gene expression systems. Scrutinizing every tool, technology, and issue impacting the future of gene and cell research, it is specifically written and organized for laymen, scholars, and specialists from varying backgrounds and disciplines to understand the current status of gene and cell therapy and anticipate future developments in the field.
| Author | : Hazel Aranha |
| Publisher | : CRC Press |
| Total Pages | : 444 |
| Release | : 2023-03-17 |
| Genre | : Science |
| ISBN | : 1000864251 |
Download Handbook of Cell and Gene Therapy Book in PDF, ePub and Kindle
This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish, as well as delivery options. Planning steps for compliance with current good manufacturing practice (cGMP) to readiness for chemistry, manufacturing and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing Discusses siRNA, mRNA, and plasmid manufacturing Describes the importance of supplier-sponsor synergies on the path to commercialization Written for a diverse audience with a large number of individuals in the core technologies and supportive practices It is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 78 |
| Release | : 2014-03-27 |
| Genre | : Medical |
| ISBN | : 030929665X |
Download Oversight and Review of Clinical Gene Transfer Protocols Book in PDF, ePub and Kindle
Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
