Guide To Cell Therapy Gxp

Author: Joaquim Vives
Editor: Academic Press
ISBN: 0128031166
Size: 14,85 MB
Format: PDF, ePub, Mobi
Read: 533

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 The Quality And Safety Of Tissues And Cells For Human Application

Author: European Directorate for the Quality of Medicines & Healthcare
ISBN: 9789287176394
Size: 10,63 MB
Format: PDF, ePub
Read: 381

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

Author: Gerhard Nahler
Editor: Springer
ISBN: 3319506692
Size: 12,17 MB
Format: PDF, Docs
Read: 663

This dictionary defines various terms typically used in pharmaceutical medicine. A new, 4th edition includes adaptations of the text to the steadily increasing regulatory requirements, particularly in the area of genetics/gene therapy, product quality (e.g., protection against falsified medicines) and of product safety (pharmacovigilance). Further evolving areas that are covered by the 4th edition are typical “grey zones” (health effects often borderline to medicinal products) such as cosmetics and dietary supplements where misleading information is prohibited on one hand but where any health claims need formal authorisation on the other. These but also other areas are reviewed and presented in an updated and – if justified – in an enlarged form.

Neural Surface Antigens

Author: Jan Pruszak
Editor: Academic Press
ISBN: 0128011262
Size: 20,77 MB
Format: PDF, ePub, Docs
Read: 803

Neural Surface Antigens: From Basic Biology towards Biomedical Applications focuses on the functional role of surface molecules in neural development, stem cell research, and translational biomedical paradigms. With an emphasis on human and rodent model systems, this reference covers fundamentals of neural stem cell biology and flow cytometric methodology. Addressing cell biologists as well as clinicians working in the neurosciences, the book was conceived by an international panel of experts to cover a vast array of particular surface antigen families and subtypes. It provides insight into the basic biology and functional mechanisms of neural cell surface signaling molecules influencing mammalian development, regeneration, and treatments. Introduces early phase clinical trials of neural stem cells Outlines characterization of surface molecule expression and methods for isolation which open unprecedented opportunities for functional study, quantitation & diagnostics Highlights the role of stem cells in neural surface antigen and biomarker analysis and applications

Quality Assurance Of Pharmaceuticals

Author: World Health Organization
Editor: World Health Organization
ISBN: 9241547081
Size: 20,48 MB
Format: PDF, ePub, Docs
Read: 469

Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Regulated Bioanalysis Fundamentals And Practice

Author: Mario L. Rocci Jr.
Editor: Springer
ISBN: 3319548026
Size: 19,17 MB
Format: PDF, Kindle
Read: 471

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

Challenges For The Fda

Author: Institute of Medicine
Editor: National Academies Press
ISBN: 9780309179447
Size: 11,91 MB
Format: PDF
Read: 423

As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.


Author: World Health Organization
Editor: World Health Organization
ISBN: 9241547553
Size: 18,44 MB
Format: PDF, Docs
Read: 768

Good laboratory practices (GLP) are the recognized rules governing the conduct of non-clinical safety studies. They ensure the quality, integrity and reliability of the study data. This handbook is designed as an aid for those countries wishing to upgrade their laboratories to GLP status. Based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP, The aim of the handbook is to provide laboratories and trainers in disease-endemic countries with the necessary technical information for implementing GLP programmes. The material in the handbook is presented in a clear and informative way. The introduction reviews the need for quality standards in drug research and development, and gives a history of GLP. Chapter 2 covers GLP training, and chapter 3, The stepwise introduction of GLP. The OECD principles of GLP and compliance monitoring are reprinted, with kind permission, In the annex section

Who Expert Committee On Specifications For Pharmaceutical Preparations

Author: World Health Organization
Editor: World Health Organization
ISBN: 9241209968
Size: 14,95 MB
Format: PDF, Docs
Read: 748

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.

Pharmaceutical Microbiology

Author: Tim Sandle
Editor: Woodhead Publishing
ISBN: 0081000448
Size: 17,29 MB
Format: PDF, ePub, Docs
Read: 385

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios