Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
Author: Joaquim Vives,Gloria Carmona
Publsiher: Academic Press
Total Pages: 266
Release: 2015-07-24
ISBN 10: 0128031166
ISBN 13: 9780128031162
Language: EN, FR, DE, ES & NL

Guide to Cell Therapy GxP Book Review:

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 Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments

Guide to Cell Therapy GxP  Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2021
ISBN 10:
ISBN 13: OCLC:972057715
Language: EN, FR, DE, ES & NL

Guide to Cell Therapy GxP Quality Standards in the Development of Cell Based Medicines in Non pharmaceutical Environments Book Review:

Exam Prep for Guide to Cell Therapy Gxp Quality Standards

Exam Prep for  Guide to Cell Therapy Gxp  Quality Standards
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2021
ISBN 10:
ISBN 13:
Language: EN, FR, DE, ES & NL

Exam Prep for Guide to Cell Therapy Gxp Quality Standards Book Review:

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
Publsiher: CRC Press
Total Pages: 379
Release: 2015-04-06
ISBN 10: 1482243636
ISBN 13: 9781482243635
Language: EN, FR, DE, ES & NL

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP Book Review:

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

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products
Author: Maria Cristina Galli,Mercedes Serabian
Publsiher: Springer
Total Pages: 230
Release: 2015-09-15
ISBN 10: 3319186183
ISBN 13: 9783319186184
Language: EN, FR, DE, ES & NL

Regulatory Aspects of Gene Therapy and Cell Therapy Products Book Review:

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.

Dictionary of Pharmaceutical Medicine

Dictionary of Pharmaceutical Medicine
Author: Gerhard Nahler
Publsiher: Springer Science & Business Media
Total Pages: 179
Release: 2013-06-29
ISBN 10: 3709140161
ISBN 13: 9783709140161
Language: EN, FR, DE, ES & NL

Dictionary of Pharmaceutical Medicine Book Review:

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.

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
Publsiher: Springer Nature
Total Pages: 424
Release: 2020-01-01
ISBN 10: 3030336565
ISBN 13: 9783030336561
Language: EN, FR, DE, ES & NL

Good Research Practice in Non Clinical Pharmacology and Biomedicine Book Review:

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.

Regenerative Biology and Medicine

Regenerative Biology and Medicine
Author: David L. Stocum
Publsiher: Academic Press
Total Pages: 474
Release: 2012-06-07
ISBN 10: 012384861X
ISBN 13: 9780123848611
Language: EN, FR, DE, ES & NL

Regenerative Biology and Medicine Book Review:

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

American Biotechnology Laboratory

American Biotechnology Laboratory
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2008
ISBN 10:
ISBN 13: STANFORD:36105123660420
Language: EN, FR, DE, ES & NL

American Biotechnology Laboratory Book Review:

Handbook

Handbook
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 309
Release: 2010-02-02
ISBN 10: 9241547553
ISBN 13: 9789241547550
Language: EN, FR, DE, ES & NL

Handbook Book Review:

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.

Translational Regenerative Medicine

Translational Regenerative Medicine
Author: Anthony Atala,Julie Allickson
Publsiher: Academic Press
Total Pages: 606
Release: 2014-12-01
ISBN 10: 0124104576
ISBN 13: 9780124104570
Language: EN, FR, DE, ES & NL

Translational Regenerative Medicine Book Review:

Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 218
Release: 2016-06-07
ISBN 10: 0128096535
ISBN 13: 9780128096536
Language: EN, FR, DE, ES & NL

How to Validate a Pharmaceutical Process Book Review:

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials
Author: J. Rick Turner
Publsiher: Unknown
Total Pages: 114
Release: 2011-09-01
ISBN 10: 9780615507675
ISBN 13: 0615507670
Language: EN, FR, DE, ES & NL

A Concise Guide to Clinical Trials Book Review:

Biopharmaceutical drugs improve the health and well-being of people across the globe on a scale that is unrivaled by any other medical intervention. Before these drugs can be prescribed for patients by their doctors, they have to be approved for marketing by a regulatory agency. To gain marketing approval, drugs must go through an extremely rigorous process that investigates their safety and efficacy, the process of New Drug Development. The last stage of this long, complex, and expensive process involves conducting clinical trials, the topic of this book. Successfully conducting clinical trials requires the interdisciplinary collaboration of individuals from many clinical and scientific disciplines and areas of operational expertise. These include medicine, information technology, ethics and law, statistics, clinical trial operations, data collection and management, regulatory science, and medical writing, to name just a few. Central aspects of conducting clinical trials are discussed in the following chapters, with the goals of making specialists from each of these areas aware of the contributions of their colleagues, and helping readers to appreciate that everyone involved in clinical research is working side-by-side toward a common goal---improving the health, well-being, and longevity of millions of patients around the globe.

The Fifth Decade

The Fifth Decade
Author: Deborah R. Wagner,Jerilynn C. Prior
Publsiher: Morgan James Publishing
Total Pages: 276
Release: 2012-05-01
ISBN 10: 1614481539
ISBN 13: 9781614481539
Language: EN, FR, DE, ES & NL

The Fifth Decade Book Review:

An indispensable and insightful roadmap for women entering the shifting landscape of life in the middle decades. With balanced, accessible, and humorous discussions of female physiology and psychology as well as current treatment options, author and psychologist Deborah R. Wagner PhD, provides an insightful and inspiring forum to help her readers get comfortable with the volatile, powerful, and colorful decades of life in the forties and fifties. With added advice for families—including a segment for partners and children—as well as candid discussions on the impact of unanticipated (but interconnected) conditions such as anxiety, depression, changing body image, loss of empathy, nurturing, and empty nesting, Dr. Wagner delivers a potent blend of science and comfort in a voice that will resonate with women of all ages. The Fifth Decade provides an essential resource to women and their families experiencing the shifts that come with the midlife years.

Minimally Invasive Aesthetic Procedures

Minimally Invasive Aesthetic Procedures
Author: Adilson Da Costa
Publsiher: Springer Nature
Total Pages: 817
Release: 2020-02-24
ISBN 10: 3319782657
ISBN 13: 9783319782652
Language: EN, FR, DE, ES & NL

Minimally Invasive Aesthetic Procedures Book Review:

Minimally invasive aesthetic procedures are an important part of dermatologists’ day-to-day clinical routine. However, plastic surgeons are also becoming more willing to explore them, and minimally invasive cosmetic and aesthetic procedures are now an established interdisciplinary topic. Minimally Invasive Aesthetic Procedures - A Guide for Dermatologists and Plastic Surgeons addresses the needs of both these specialties. It provides a comprehensive overview of the most relevant and widely used minimally invasive procedures, presented in a practical and straightforward style. Rather than a broad overview of the literature, it offers a step-by-step guide to clinical procedures. Each chapter explores a single clinical procedure, discussing the theoretical basis; the materials needed; the methods and techniques; clinical follow-up; before-and-after illustrations; as well as the side effects and complications and their management. It also includes a summary of tips and relevant references. With more than a hundred procedures presented and discussed in a clinically applicable format, Minimally Invasive Aesthetic Procedures - A Guide for Dermatologists and Plastic Surgeons is a practical manual for all dermatology and plastic surgery practitioners who are interested in aesthetic medicine.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Author: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization
Publsiher: World Health Organization
Total Pages: 358
Release: 2016
ISBN 10: 9241209968
ISBN 13: 9789241209960
Language: EN, FR, DE, ES & NL

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book Review:

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality, safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines, from their development to their distribution to patients. In the area of quality control, the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia, and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM), the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs, general texts and ICRS. It noted the report on Phase 6 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further acknowledged the progress of good pharmacopoeial practices (GPhP), and adopted the document on GPhP which was prepared by the consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP), distribution and trade of pharmaceuticals and regulatory practice. It adopted 10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.

Cell Therapy

Cell Therapy
Author: Adrian Gee
Publsiher: Springer Science & Business Media
Total Pages: 256
Release: 2009-09-18
ISBN 10: 9780387895840
ISBN 13: 0387895841
Language: EN, FR, DE, ES & NL

Cell Therapy Book Review:

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.

Development of Therapeutic Cancer Vaccines

Development of Therapeutic Cancer Vaccines
Author: Fred Brown,John C. Petricianni
Publsiher: S Karger Ag
Total Pages: 243
Release: 2004
ISBN 10:
ISBN 13: UOM:39015060584177
Language: EN, FR, DE, ES & NL

Development of Therapeutic Cancer Vaccines Book Review:

This monograph contains the proceedings of a conference devoted to progress and emerging issues in therapeutic cancer vaccine development since the 1998 FDA/NCI workshop. The emphasis is on progress in the clinical trials of cancer vaccines in late-stage development, but the volume also includes presentations and discussions on exciting earlier-stage products as well as updates on regulatory positions in the USA, Canada, Europe, and Australia. Session I concentrates on regulatory considerations in cancer vaccine development, including a round table of regulatory agency representatives from North America, Europe, and Australia. Session II continues with a consideration of several different types of cancer vaccines, including whole cells, cell lysates, multivalent recombinants and peptides. Session III highlights dendritic cell vaccines and dendritic cells fused to tumour cell vaccines. Session IV focuses on preventive cancer vaccines for cervical carcinoma and liver cancer and various aspects of the immune response to cancer vaccines.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 299
Release: 2019-05-15
ISBN 10: 9241210281
ISBN 13: 9789241210287
Language: EN, FR, DE, ES & NL

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book Review:

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating, ventilation and air-conditioning systems (HVAC) illustrative part; Guidance on GMP for Validation, including the general main text, analytical procedure validation, validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.

Cancer Immunotherapy

Cancer Immunotherapy
Author: George C. Prendergast,Elizabeth M. Jaffee
Publsiher: Elsevier
Total Pages: 428
Release: 2011-04-28
ISBN 10: 9780080521855
ISBN 13: 0080521851
Language: EN, FR, DE, ES & NL

Cancer Immunotherapy Book Review:

There has been major growth in understanding immune suppression mechanisms and its relationship to cancer progression and therapy. This book highlights emerging new principles of immune suppression that drive cancer and it offers radically new ideas about how therapy can be improved by attacking these principles. Following work that firmly establishes immune escape as an essential trait of cancer, recent studies have now defined specific mechanisms of tumoral immune suppression. It also demonstrates how attacking tumors with molecular targeted therapeutics or traditional chemotherapeutic drugs can produce potent anti-tumor effects in preclinical models. This book provides basic, translational, and clinical cancer researchers an indispensable overview of immune escape as a critical trait in cancer and how applying specific combinations of immunotherapy and chemotherapy to attack this trait may radically improve the treatment of advanced disease. * Offers a synthesis of concepts that are useful to cancer immunologists and pharmacologists, who tend to work in disparate fields with little cross-communication * Drs Prendergast and Jaffee are internationally recognized leaders in cancer biology and immunology who have created a unique synthesis of fundamental and applied concepts in this important new area of cancer research * Summarizes the latest insights into how immune escape defines an essential trait of cancer * Includes numerous illustrations including: how molecular-targeted therapeutic drugs or traditional chemotherapy can be combined with immunotherapy to improve anti-tumor efficacy; and how reversing immune suppression by the tumor can cause tumor regression