November 27, 2020

Download Ebook Free Guide To Cell Therapy GxP

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
Author : Joaquim Vives,Gloria Carmona
Publisher : Academic Press
Release Date : 2015-07-24
Category : Medical
Total pages :266
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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

Exam Prep for: Guide to Cell Therapy Gxp; Quality Standards ...

Exam Prep for: Guide to Cell Therapy Gxp; Quality Standards ...
Author : Anonim
Publisher : Unknown
Release Date : 2020
Category :
Total pages :129
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EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Author : Orlando Lopez
Publisher : CRC Press
Release Date : 2015-04-06
Category : Computers
Total pages :379
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Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is

Cell Therapy

Cell Therapy
Author : Adrian Gee
Publisher : Springer Science & Business Media
Release Date : 2009-09-18
Category : Science
Total pages :256
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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.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release Date : 2014-06-03
Category : Medical
Total pages :545
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A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Ensuring the Integrity of Electronic Health Records

Ensuring the Integrity of Electronic Health Records
Author : Orlando Lopez
Publisher : CRC Press
Release Date : 2020-12-22
Category : Business & Economics
Total pages :320
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Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products
Author : Maria Cristina Galli,Mercedes Serabian
Publisher : Springer
Release Date : 2015-09-15
Category : Medical
Total pages :230
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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.

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

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
Category : Cell transplantation
Total pages :320
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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

Dictionary of Pharmaceutical Medicine

Dictionary of Pharmaceutical Medicine
Author : Gerhard Nahler
Publisher : Springer Science & Business Media
Release Date : 2013-06-29
Category : Medical
Total pages :179
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This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.

Stem Cells and Cell Therapy

Stem Cells and Cell Therapy
Author : Mohamed Al-Rubeai,Mariam Naciri
Publisher : Springer Science & Business Media
Release Date : 2013-10-01
Category : Medical
Total pages :189
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With the discovery of stem cells capable of multiplying indefinitely in culture and differentiating into many other cell types in appropriate conditions, new hopes were born in repair and replacement of damaged cells and tissues. The features of stem cells may provide treatment for some incurable diseases with some therapies are already in clinics, particularly those from adult stem cells. Some treatments will require large number of cells and may also require multiple doses, generating a growing demand for generating and processing large numbers of cells to meet the need of clinical applications. With this in mind, our aim is to provide a book on the subject of stem cells and cell therapy for researchers and students of cell biotechnology, bioengineering and bioproduction. This book is exceptional as it teaches researchers stem cells and cell therapy in that it covers the concepts and backgrounds necessary so that readers get a good understanding of the production of stem cells. The book covers three topics: The basics of stem cells and cell therapy, the use of stem cells for the treatment of human diseases, and stem cell processing. It includes chapters on neural and vascular stem vascular stem cell therapy, expansion engineering of embryonic stem cells, stem cell based production of blood cells and separation technologies for stem cells and cell therapy products. It is an informed and informative presentation of what modern research, science and engineering have learned about stem cells and their production and therapies. Addressing both the medical and production issues, this book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.

Handbook

Handbook
Author : World Health Organization
Publisher : World Health Organization
Release Date : 2010-02-02
Category : Medical
Total pages :309
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A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian writings. One day love, in the shape of Félicien Hautecoeur, enters the dream world she has constructed around herself, bringing about upheaval and distress. Although it provides a detailed portrait of provincial 19th-century life and it adheres to a naturalist approach, The Dream eschews many of the characteristics of Zola's other novels of the Rougon-Macquart cycle—such as a pronounced polemical agenda or a gritty subject matter—offering instead a timeless, lyrical tale of love and innocence.

American Biotechnology Laboratory

American Biotechnology Laboratory
Author : Anonim
Publisher : Unknown
Release Date : 2008
Category : Bioengineering
Total pages :129
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Regenerative Biology and Medicine

Regenerative Biology and Medicine
Author : David L. Stocum
Publisher : Academic Press
Release Date : 2012-06-07
Category : Technology & Engineering
Total pages :474
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Regenerative Biology and Medicine, Second Edition — Winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — discusses the fundamentals of regenerative biology and medicine. It provides a comprehensive overview, which integrates old and new data into an ever-clearer global picture. The book is organized into three parts. Part I discusses the mechanisms and the basic biology of regeneration, while Part II deals with the strategies of regenerative medicine developed for restoring tissue, organ, and appendage structures. Part III reflects on the achievements of regenerative biology and medicine; future challenges; bioethical issues that need to be addressed; and the most promising developments in regenerative medicine. The book is designed for multiple audiences: undergraduate students, graduate students, medical students and postdoctoral fellows, and research investigators interested in an overall synthesis of this field. It will also appeal to investigators from fields not directly related to regenerative biology and medicine, such as chemistry, informatics, computer science, mathematics, physics, and engineering. Highly Commended 2013 BMA Medical Book Award for Medicine Includes coverage of skin, hair, teeth, cornea, and central neural tissues Provides description of regenetive medicine in digestive, respiratory, urogenital, musculoskeletal, and cardiovascular systems Includes amphibians as powerful research models with discussion of appendage regeneration in amphibians and mammals

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Good Research Practice in Non-Clinical Pharmacology and Biomedicine
Author : Anton Bespalov,Martin C. Michel,Thomas Steckler
Publisher : Springer Nature
Release Date : 2020-01-01
Category : Cardiology
Total pages :424
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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.