Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products PDF

Author: Maria Cristina Galli

Publisher: Springer Nature

Published: 2023-08-01

Total Pages: 243

ISBN-13: 3031345673

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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.

First WHO Model List of Essential In Vitro Diagnostics

First WHO Model List of Essential In Vitro Diagnostics PDF

Author: World Health Organization

Publisher: World Health Organization

Published: 2019-05-16

Total Pages: 73

ISBN-13: 9241210265

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The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.

Hypercalcemia of Malignancy

Hypercalcemia of Malignancy PDF

Author: Friedhelm Raue

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 238

ISBN-13: 3642850731

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Hypercalcemia is the most common life-threatening metabolic disorder associated with cancer. The pathophysiological, epidemiological and clinical aspects of hypercalcemia of malignancy are presented in this issue, with a focus on the recently discovered humoral factor responsible for the development of hypercalcemia. With a better understanding of the pathophysiology of this condition and the development of new potent drugs, capable of inhibiting bone resorption, especially bisphosphonates, the clinician will be more successful in correcting hypercalcemia in the great majority of patients.

New Developments in Blood Transfusion Research

New Developments in Blood Transfusion Research PDF

Author: Brian R. Peterson

Publisher: Nova Publishers

Published: 2006

Total Pages: 200

ISBN-13: 9781594549625

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Although blood transfusion saves lives and reduces morbidities in many clinical diseases and conditions, it is associated with certain risks. A transfusion-related adverse event, also called transfusion reaction, is any unfavourable event occurring in a patient during or after blood transfusion. About 0.5 per cent to 3 per cent of all transfusions result in some adverse events, but the majority of them are minor reactions with no significant consequences. In general, transfusion-related adverse events are categorised as infectious and non-infectious. However, there are other classifications in the literature based on time of occurrence (i.e. acute versus delayed) or physiological mechanism (i.e. immune mediated versus non-immune mediated). A significant proportion of adverse events may occur as a result of errors in preparation, ordering or administration of blood and blood products. This book contains the latest research in this essential field which has been revolutionised in recent decades.

The European Blood and Marrow Transplantation Textbook for Nurses

The European Blood and Marrow Transplantation Textbook for Nurses PDF

Author: Michelle Kenyon

Publisher: Springer

Published: 2018-03-14

Total Pages: 311

ISBN-13: 3319500260

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This book is open access under a CC BY 4.0 license. This textbook, endorsed by the European Society for Blood and Marrow Transplantation (EBMT), provides adult and paediatric nurses with a full and informative guide covering all aspects of transplant nursing, from basic principles to advanced concepts. It takes the reader on a journey through the history of transplant nursing, including essential and progressive elements to help nurses improve their knowledge and benefit the patient experience, as well as a comprehensive introduction to research and auditing methods. This new volume specifically intended for nurses, complements the ESH-EBMT reference title, a popular educational resource originally developed in 2003 for physicians to accompany an annual training course also serving as an educational tool in its own right. This title is designed to develop the knowledge of nurses in transplantation. It is the first book of its kind specifically targeted at nurses in this specialist field and acknowledges the valuable contribution that nursing makes in this area. This volume presents information that is essential for the education of nurses new to transplantation, while also offering a valuable resource for more experienced nurses who wish to update their knowledge.

Peripheral T-cell Lymphomas

Peripheral T-cell Lymphomas PDF

Author: Pier Paolo Piccaluga

Publisher: BoD – Books on Demand

Published: 2019-08-07

Total Pages: 134

ISBN-13: 1838812253

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In this book the reader will find a collection of chapters written by different research teams describing different aspects of peripheral T-cell lymphoma pathobiology, classification, and treatment. This work is mainly addressed to researchers already working in this area, but it is also accessible to anyone with a scientific background who desires to have an updated overview of the recent progress in this domain. It will also be valuable to scientists and physicians who have become newly involved in this field. Each chapter is self-contained and can be read independently of the others. This book intends to provide highlights of the current research as well as the current gold standards for diagnosis and treatment of these diseases, showing the recent advances in the personalized approach to T-cell derived lymphomas.

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