Fast Track Therapie
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Gene And Cell Therapies
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Author : Eve Hanna
language : en
Publisher: CRC Press
Release Date : 2020-05-19
Gene And Cell Therapies written by Eve Hanna and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-19 with Medical categories.
The major advances in the field of biotechnology and molecular biology in the twenty-first century have led to a better understanding of the pathophysiology of diseases. A new generation of biopharmaceuticals has emerged, including a wide and heterogeneous range of innovative cell and gene therapies. These therapies aim to prevent or treat chronic and serious life-threatening diseases, previously considered incurable. This book describes the evolution and adaptation of the regulatory environment to assess these therapies in contrast with the resistance of health technology assessment (HTA) agencies and payers to acknowledge the specificity of cell and gene therapies and the need to adapt existing decision-making frameworks. This book provides insights on the learnings from the experience of current cell and gene therapies (regulatory approval, HTA, and market access), in addition to future trends to enhance patient access to these therapies. Key Features: Describes the potential change of treatment paradigm and the specificity of cell and gene therapies, including the gradual move from repeated treatment administration to one-time single administration with the potential to be definite cure Highlights the challenges at the HTA level Discusses the affordability of future cell and gene therapies and the possible challenges for health insurance systems Provides potential solutions to address these challenges and ensure patient access to innovation while maintaining the sustainability of healthcare systems
Regulatory Aspects Of Gene Therapy And Cell Therapy Products
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Author : Maria Cristina Galli
language : en
Publisher: Springer Nature
Release Date : 2023-08-01
Regulatory Aspects Of Gene Therapy And Cell Therapy Products written by Maria Cristina Galli and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-01 with Science categories.
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.
Reactive Oxygen Species Ros Nanoparticles And Endoplasmic Reticulum Er Stress Induced Cell Death Mechanisms
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Author : Loutfy H. Madkour
language : en
Publisher: Academic Press
Release Date : 2020-06-27
Reactive Oxygen Species Ros Nanoparticles And Endoplasmic Reticulum Er Stress Induced Cell Death Mechanisms written by Loutfy H. Madkour and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-27 with Medical categories.
Reactive Oxygen Species (ROS), Nanoparticles, and Endoplasmic Reticulum (ER) Stress-Induced Cell Death Mechanisms presents the role of ROS?mediated pathways cellular signaling stress, endoplasmic reticulum (ER) stress, oxidative stress, oxidative damage, nanomaterials, and the mechanisms by which metalloids and nanoparticles induce their toxic effects. The book covers the ecotoxicology of environmental heavy metal ions and free radicals on macromolecules cells organisms, heavy metals?induced cell responses, oxidative stress, the source of oxidants, and the roles of ROS, oxidative stress and oxidative damage mechanisms. It also examines the nanotoxicity, cytotoxicity and genotoxicity mechanisms of nanomaterials and the effects of nanoparticle interactions. Antioxidant defense therapy and strategies for treatment round out the book, making it an ideal resource for researchers and professional scientists in toxicology, environmental chemistry, environmental science, nanomaterials and the pharmaceutical sciences. Covers the ecotoxicology of environmental heavy metal ions and the interactions between specific heavy metals?induced cell responses and oxidative stress Provides a better understanding of the mechanism of nanomaterial-induced toxicity as a first defense for hazard prevention Covers recent advances in new nanomedication technologies for the effects of NPs on oxidative stress, ROS and ER stress Discusses the effects of interactions between antioxidant defense therapy, ROS and strategies for treatment
Regulatory Affairs In The Pharmaceutical Industry
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Author : Javed Ali
language : en
Publisher: Academic Press
Release Date : 2021-11-14
Regulatory Affairs In The Pharmaceutical Industry written by Javed Ali and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-14 with Medical categories.
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Technological Innovation
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Author : Marie C. Thursby
language : en
Publisher: Emerald Group Publishing
Release Date : 2016-08-23
Technological Innovation written by Marie C. Thursby and has been published by Emerald Group Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-23 with Business & Economics categories.
This is the 2nd edition of Technological Innovation. Profiting from technological innovation requires scientific and engineering expertise, and an understanding of how business and legal factors facilitate commercialization. This volume presents a multidisciplinary view of issues in technology commercialization and entrepreneurship.
Was Gibt Es Neues In Der Chirurgie Jb 2010
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Author : Konrad Meßmer
language : de
Publisher: ecomed-Storck GmbH
Release Date :
Was Gibt Es Neues In Der Chirurgie Jb 2010 written by Konrad Meßmer and has been published by ecomed-Storck GmbH this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Epilepsy
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Author : Gregory D. Cascino
language : en
Publisher: John Wiley & Sons
Release Date : 2021-02-19
Epilepsy written by Gregory D. Cascino and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-19 with Medical categories.
Designed to provide a comprehensive but accessible introduction to epilepsy and seizure disorders, Epilepsy, 2nd edition provides state-of-the-art information in a concise format useful to a wide audience, from neurology residents to epilepsy fellows and practitioners. This illustrated guide to the assessment, diagnosis, and treatment of epilepsy is a valuable resource enabling clinicians to stay on top of the latest recommendations for best practice.
Issues In Pain Therapies And Research 2011 Edition
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Author :
language : en
Publisher: ScholarlyEditions
Release Date : 2012-01-09
Issues In Pain Therapies And Research 2011 Edition written by and has been published by ScholarlyEditions this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-09 with Medical categories.
Issues in Pain Therapies and Research / 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pain Therapies and Research. The editors have built Issues in Pain Therapies and Research: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pain Therapies and Research in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pain Therapies and Research: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Handbook Of Evidence Based Therapies For Children And Adolescents
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Author : Ric G. Steele
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-12-03
Handbook Of Evidence Based Therapies For Children And Adolescents written by Ric G. Steele and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-03 with Psychology categories.
The comprehensive coverage in this hugely important and timely handbook makes it invaluable to clinical child, school, and counseling psychologists; clinical social workers; and child psychiatrists. As a textbook for advanced clinical and counseling psychology programs, and a solid reference for the researcher in child/adolescent mental health, its emphasis on flexibility and attention to emerging issues will help readers meet ongoing challenges, as well as advance the field. Its relevance cannot be overstated, as growing numbers of young people have mental health problems requiring intervention, and current policy initiatives identify evidence-based therapies as the most effective and relevant forms of treatment.
Handbook Of Neuroemergency Clinical Trials
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Author : Wayne M. Alves
language : en
Publisher: Elsevier
Release Date : 2006-01-18
Handbook Of Neuroemergency Clinical Trials written by Wayne M. Alves and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-18 with Medical categories.
During the 1990’s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were “tested, and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors’ perspectives. * Presents new perspectives on acute neuroemergency clinical trials * Includes insights from clinical pharmacology and industry perspectives* Discusses historical lessons learned from early and recent trials in acute neuroscience populations