Good Laboratory Practice Glp Training Manual For The Trainee

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Good Laboratory Practice Training Manual

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 924154757X
Total Pages : 265 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Good Laboratory Practice Training Manual by : World Health Organization

Download or read book Good Laboratory Practice Training Manual written by World Health Organization and published by World Health Organization. This book was released on 2010-02-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual is designed to be used by the trainee at Special Program for Research and Training in Tropical Diseases and Good Laboratory Practice training workshops. It contains an introduction which highlights the history of the OECD principles of GLP, and the fundamental points. Included is training on the resources required (personnel and facilities); preparation of the protocol and standard operating procedures (SOPs); characterization of the test item (its storage, use, quality control, test system); documentation (reporting, deviations from the protocol, indexing, archiving, retrieval); and quality assurance (validity of results must be ensured through all phases of a study). The material is presented in a clear, lively and informative way. Also included are several practical and interesting workshops on how to prepare, review and improve protocols and standard operating procedures, based on actual case studies. Finally there is a self-assessment questionnaire-so the trainee can recognize how much he/she has learned and what issues need clarification, if any.

Good Laboratory Practice Training Manual

Author : World Health Organization
Publisher :
ISBN 13 : 9789241547567
Total Pages : 0 pages
Book Rating : 4.5/5 (475 download)

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Book Synopsis Good Laboratory Practice Training Manual by : World Health Organization

Download or read book Good Laboratory Practice Training Manual written by World Health Organization and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual is aimed at trainers of good laboratory practice (GLP) and is a companion manual to the GLP training manual for the trainee.

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 135111025X
Total Pages : 4031 pages
Book Rating : 4.3/5 (511 download)

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Book Synopsis Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by : Shein-Chung Chow

Download or read book Encyclopedia of Biopharmaceutical Statistics - Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4031 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Research Regulatory Compliance

Author : Mark A. Suckow
Publisher : Academic Press
ISBN 13 : 0124200656
Total Pages : 345 pages
Book Rating : 4.1/5 (242 download)

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Book Synopsis Research Regulatory Compliance by : Mark A. Suckow

Download or read book Research Regulatory Compliance written by Mark A. Suckow and published by Academic Press. This book was released on 2015-06-14 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. - Provides a "one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models - Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment - Focuses on United States regulations, covering both animal models and human subjects - Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Quality Assurance Implementation in Research Labs

Author : Akshay Anand
Publisher : Springer Nature
ISBN 13 : 9811630747
Total Pages : 247 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Quality Assurance Implementation in Research Labs by : Akshay Anand

Download or read book Quality Assurance Implementation in Research Labs written by Akshay Anand and published by Springer Nature. This book was released on 2021-08-17 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”

TDR News

Author :
Publisher :
ISBN 13 :
Total Pages : 428 pages
Book Rating : 4.:/5 (9 download)

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Book Synopsis TDR News by :

Download or read book TDR News written by and published by . This book was released on 2006 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Occupational Safety and Hygiene III

Author : Pedro M. Arezes
Publisher : CRC Press
ISBN 13 : 1315692937
Total Pages : 488 pages
Book Rating : 4.3/5 (156 download)

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Book Synopsis Occupational Safety and Hygiene III by : Pedro M. Arezes

Download or read book Occupational Safety and Hygiene III written by Pedro M. Arezes and published by CRC Press. This book was released on 2015-02-02 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: The papers published in Occupational Safety and Hygiene III cover the following topics:- Occupational safety- Risk assessment- Safety management- Ergonomics- Management systems- Environmental ergonomics- Physical environments- Construction safety, and- Human factors.The contributions are based on research carried out at universities and other resea

Translational Sports Medicine

Author : Jeffrey A. Bakal
Publisher : Elsevier
ISBN 13 : 0323913342
Total Pages : 622 pages
Book Rating : 4.3/5 (239 download)

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Book Synopsis Translational Sports Medicine by : Jeffrey A. Bakal

Download or read book Translational Sports Medicine written by Jeffrey A. Bakal and published by Elsevier. This book was released on 2023-08-14 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Sports Medicine covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. This title is an indispensable tool in grant writing and funding efforts with its practical, straightforward approach that will help aspiring investigators navigate challenging considerations in study design and implementation. It provides valuable discussions of the critical appraisal of published studies in translational sports medicine, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every medical researcher or sports medicine clinician who has ever had a good clinical idea but not the knowledge of how to test it. Readers will come to fully understand important concepts, including case-control study, prospective cohort study, randomized trial and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in translational sports medicine, and know what is needed in collaboration. - Focuses on the principles of evidence-based medicine and applies these principles to translational investigations within sports medicine - Details discussions of the critical appraisal of published studies in translational sports medicine, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care - Written by experts in the sports medicine field

Freshney's Culture of Animal Cells

Author : R. Ian Freshney
Publisher : John Wiley & Sons
ISBN 13 : 1119513030
Total Pages : 832 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Freshney's Culture of Animal Cells by : R. Ian Freshney

Download or read book Freshney's Culture of Animal Cells written by R. Ian Freshney and published by John Wiley & Sons. This book was released on 2021-02-17 with total page 832 pages. Available in PDF, EPUB and Kindle. Book excerpt: FRESHNEY’S CULTURE OF ANIMAL CELLS THE NEW EDITION OF THE LEADING TEXT ON THE BASIC METHODOLOGY OF CELL CULTURE, FULLY UPDATED TO REFLECT NEW APPLICATIONS INCLUDING IPSCS, CRISPR, AND ORGAN-ON-CHIP TECHNOLOGIES Freshney’s Culture of Animal Cells is the most comprehensive and up-to-date resource on the principles, techniques, equipment, and applications in the field of cell and tissue culture. Explaining both how to do tissue culture and why a technique is done in a particular way, this classic text covers the biology of cultured cells, how to select media and substrates, regulatory requirements, laboratory protocols, aseptic technique, experimental manipulation of animal cells, and much more. The eighth edition contains extensively revised material that reflects the latest techniques and emerging applications in cell culture, such as the use of CRISPR/Cas9 for gene editing and the adoption of chemically defined conditions for stem cell culture. A brand-new chapter examines the origin and evolution of cell lines, joined by a dedicated chapter on irreproducible research, its causes, and the importance of reproducibility and good cell culture practice. Throughout the book, updated chapters and protocols cover topics including live-cell imaging, 3D culture, scale-up and automation, microfluidics, high-throughput screening, and toxicity testing. This landmark text: Provides comprehensive single-volume coverage of basic skills and protocols, specialized techniques and applications, and new and emerging developments in the field Covers every essential area of animal cell culture, including lab design, disaster and contingency planning, safety, bioethics, media preparation, primary culture, mycoplasma and authentication testing, cell line characterization and cryopreservation, training, and troubleshooting Features a wealth of new content including protocols for gene delivery, iPSC generation and culture, and tumor spheroid formation Includes an updated and expanded companion website containing figures, artwork, and supplementary protocols to download and print The eighth edition of Freshney’s Culture of Animal Cells is an indispensable volume for anyone involved in the field, including undergraduate and graduate students, clinical and biopharmaceutical researchers, bioengineers, academic research scientists, and managers, technicians, and trainees working in cell biology, molecular biology, and genetics laboratories.

Tropical Disease Research

Author :
Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.5/5 (861 download)

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Book Synopsis Tropical Disease Research by :

Download or read book Tropical Disease Research written by and published by . This book was released on 2001 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Chemical Technicians

Author : Mohamed Elzagheid
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3111191494
Total Pages : 138 pages
Book Rating : 4.1/5 (111 download)

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Book Synopsis Chemical Technicians by : Mohamed Elzagheid

Download or read book Chemical Technicians written by Mohamed Elzagheid and published by Walter de Gruyter GmbH & Co KG. This book was released on 2023-07-24 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book for chemical technicians contains a variety of skills that chemical technicians and technicians who work in chemical plants should develop as part of their successful experience. Many of these competencies were unintentionally addressed in other resources in a dispersed way across chapters in various textbooks and internet resources, but many others were not. The book also provides a brief overview of the tasks that various chemical laboratory technicians must perform as part of their employment. It also includes a thorough explanation of the sampling techniques, chemical analysis, and a description of the various tools and methods used in chemical labs. Additionally the book covers information management systems and good practices in laboratories, as well as how these have allowed and facilitated best practices in laboratories and the gathering of data that improves technicians’ experience and knowledge. Finally, some advice on using lab glassware, laboratory emergency first aid, and a short description of the chemicals that chemical technicians frequently use are provided.

The Role of the Study Director in Nonclinical Studies

Author : William J. Brock
Publisher : John Wiley & Sons
ISBN 13 : 1118874080
Total Pages : 568 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis The Role of the Study Director in Nonclinical Studies by : William J. Brock

Download or read book The Role of the Study Director in Nonclinical Studies written by William J. Brock and published by John Wiley & Sons. This book was released on 2014-05-02 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Quality Control Training Manual

Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 143985016X
Total Pages : 484 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Quality Control Training Manual by : Syed Imtiaz Haider

Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

Good Laboratory Practice Regulations, Revised and Expanded

Author : Sandy Weinberg
Publisher : CRC Press
ISBN 13 : 0203911083
Total Pages : 249 pages
Book Rating : 4.2/5 (39 download)

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Book Synopsis Good Laboratory Practice Regulations, Revised and Expanded by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations, Revised and Expanded written by Sandy Weinberg and published by CRC Press. This book was released on 2002-11-06 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g

Handbook

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241547553
Total Pages : 328 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Handbook by : World Health Organization

Download or read book Handbook written by World Health Organization and published by World Health Organization. This book was released on 2010-02-02 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

District Laboratory Practice in Tropical Countries, Part 2

Author : Monica Cheesbrough
Publisher : Cambridge University Press
ISBN 13 : 113944929X
Total Pages : 464 pages
Book Rating : 4.1/5 (394 download)

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Book Synopsis District Laboratory Practice in Tropical Countries, Part 2 by : Monica Cheesbrough

Download or read book District Laboratory Practice in Tropical Countries, Part 2 written by Monica Cheesbrough and published by Cambridge University Press. This book was released on 2006-03-02 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition includes an update on HIV disease/AIDS, recently developed HIV rapid tests to diagnose HIV infection and screen donor blood, and current information on antiretroviral drugs and the laboratory monitoring of antiretroviral therapy. Information on the epidemiology and laboratory investigation of other pathogens has also been brought up to date. Several new, rapid, simple to perform immunochromatographic tests to assist in the diagnosis of infectious diseases are described, including those for brucellosis, cholera, dengue, leptospirosis, syphilis and hepatitis. Recently developed lgM antibody tests to investigate typhoid fever are also described. The new classification of salmonellae has been introduced. Details of manufacturers and suppliers now include website information and e-mail addresses. The haematology and blood transfusion chapters have been updated, including a review of haemoglobin measurement methods in consideration of the high prevalence of anaemia in developing countries.

Quality Assurance in Analytical Chemistry

Author : Bernd W. Wenclawiak
Publisher : Springer Science & Business Media
ISBN 13 : 3642136095
Total Pages : 343 pages
Book Rating : 4.6/5 (421 download)

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Book Synopsis Quality Assurance in Analytical Chemistry by : Bernd W. Wenclawiak

Download or read book Quality Assurance in Analytical Chemistry written by Bernd W. Wenclawiak and published by Springer Science & Business Media. This book was released on 2010-08-05 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: knowledge. This material provided has been collected from different sources. One important source is the material available from EURACHEM. Eurachem is a network of organisations in Europe having the objective of establishing a system for the international tra- ability of chemical measurements and the promotion of good quality practices. It provides a forum for the discussion of common problems and for developing an informed and considered approach to both technical and policy issues. It provides a focus for analytical chemistry and quality related issues in Europe. You can find more information about EURACHEM on the internet via “Eurachem –A Focus for Analytical Chemistry in Europe” (http://www.eurachem.org). In particular the site Guides and Documents contains a number of different guides, which might help you to set up a quality system in your laboratory. The importance of quality assurance in analytical chemistry can best be described by the triangles depicted in Figs. 1 and 2. Quality is checked by testing and testing guaranties good quality. Both contribute to progress in QA (product control and quality) and thus to establishing a market share. Market success depends on quality, price, and flexibility. All three of them are interconnected. Before you can analyse anything the sample must be taken by someone. This must be of major concern to any analytical chemist. There is no accurate analysis wi- out proper sampling. For correct sampling you need a clear problem definition. There is no correct sampling without a clear problem definition