Author : Seiler
Publisher : Unknown
Page : 424 pages
File Size : 54,8 Mb
Release : 2007-07-01
Category : Electronic
ISBN : 8181286979
Good Laboratory Practice, 2E
Seiler
Good Laboratory Practice 2e
Good Laboratory Practice 2e Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Good Laboratory Practice 2e book. This book definitely worth reading, it is an incredibly well-written.
Handbook
World Health Organization
Author : World Health Organization
Publisher : World Health Organization
Page : 328 pages
File Size : 55,5 Mb
Release : 2010-02-02
Category : Medical
ISBN : 9789241547550
Handbook by World Health Organization Pdf
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.
Good Laboratory Practice Regulations, Revised and Expanded
Sandy Weinberg
Author : Sandy Weinberg
Publisher : CRC Press
Page : 249 pages
File Size : 43,5 Mb
Release : 2002-11-06
Category : Medical
ISBN : 9780203911082
Good Laboratory Practice Regulations, Revised and Expanded by Sandy Weinberg Pdf
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
GLP Essentials
Milton A. Anderson
Author : Milton A. Anderson
Publisher : CRC Press
Page : 67 pages
File Size : 53,5 Mb
Release : 2002
Category : Medical
ISBN : 1574911384
GLP Essentials by Milton A. Anderson Pdf
Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. The author includes a brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for individual and group training programs.
Good Laboratory Practice
Jürg P. Seiler
Author : Jürg P. Seiler
Publisher : Springer Science & Business Media
Page : 404 pages
File Size : 55,6 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642868788
Good Laboratory Practice by Jürg P. Seiler Pdf
After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.
Good Laboratory Practice Regulations
Sandy Weinberg
Author : Sandy Weinberg
Publisher : CRC Press
Page : 304 pages
File Size : 46,5 Mb
Release : 2007-01-19
Category : Medical
ISBN : 9780849375842
Good Laboratory Practice Regulations by Sandy Weinberg Pdf
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse
Good Laboratory Practice Standards
Willa Y. Garner,Maureen S. Barge,James P. Ussary
Author : Willa Y. Garner,Maureen S. Barge,James P. Ussary
Publisher : Oxford University Press, USA
Page : 600 pages
File Size : 41,9 Mb
Release : 1992
Category : Pesticides
ISBN : UCAL:B4526096
Good Laboratory Practice Standards by Willa Y. Garner,Maureen S. Barge,James P. Ussary Pdf
Written by experienced quality assurance (QA) professionals and field laboratory researchers. Provides concrete ideas for establishing a compliance program and refining the compliance process. Outlines approaches that have resulted in successful compliance and describes methods of avoiding some of the common mistakes. Appendices contain the entire GLP Enforcement Response Policy, a question-and-answer section, examples of forms for submitting data to the EPA, and the EPA's penalty policy.
Good Laboratory Practice
Anonim
Author : Anonim
Publisher : Unknown
Page : 20 pages
File Size : 46,9 Mb
Release : 1979
Category : Electronic
ISBN : OCLC:68025237
Good Laboratory Practice by Anonim Pdf
Good Laboratory Practice
Mindy J. Allport-Settle
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
Page : 276 pages
File Size : 49,7 Mb
Release : 2010-10
Category : Medical
ISBN : 0983071918
Good Laboratory Practice by Mindy J. Allport-Settle Pdf
This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Good Laboratory Practice regulations, guidance, and associated documents for pharmaceutical, biologics and medical device products nonclinical trials. Good Laboratory Practice Regulations and Guidance: * FDA Overview and Orientation * Overview of GCP and Introduction to GLP * Part I: Federal Regulations Relating to Good Laboratory Practice o Parts 58: Good Laboratory Practice for Nonclinical Laboratory Studies o 1987 Final Rule - Good Laboratory Practice Regulations * Part II: Guidance Documents o Bioresearch Monitoring Good Laboratory Practice o Good Laboratory Practices Questions and Answers * Part III: Redbook 2000 o IV.B.1 General Guidelines for Designing and Conducting Toxicity Studies o IV.B.2 Guidelines for Reporting the Results of Toxicity Studies Reference Tools * Part IV: Combined Glossary and Index
Good Laboratory Practice Training Manual
World Health Organization
Author : World Health Organization
Publisher : World Health Organization
Page : 265 pages
File Size : 47,5 Mb
Release : 2010-02-02
Category : Medical
ISBN : 9789241547574
Good Laboratory Practice Training Manual by World Health Organization Pdf
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.
District Laboratory Practice in Tropical Countries
Monica Cheesbrough
Author : Monica Cheesbrough
Publisher : Cambridge University Press
Page : 128 pages
File Size : 49,7 Mb
Release : 2006-03-02
Category : Medical
ISBN : 9781139449298
District Laboratory Practice in Tropical Countries by Monica Cheesbrough Pdf
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.
Validation of Cell-Based Assays in the GLP Setting
Uma Prabhakar,Marian Kelley
Author : Uma Prabhakar,Marian Kelley
Publisher : John Wiley & Sons
Page : 312 pages
File Size : 50,5 Mb
Release : 2008-04-30
Category : Science
ISBN : 0470987804
Validation of Cell-Based Assays in the GLP Setting by Uma Prabhakar,Marian Kelley Pdf
The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines. In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development. This book: Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development.
Prudent Practices in the Laboratory
National Research Council,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Committee on Prudent Practices in the Laboratory: An Update
Author : National Research Council,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Committee on Prudent Practices in the Laboratory: An Update
Publisher : National Academies Press
Page : 360 pages
File Size : 49,8 Mb
Release : 2011-03-25
Category : Science
ISBN : 9780309211581
Prudent Practices in the Laboratory by National Research Council,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Committee on Prudent Practices in the Laboratory: An Update Pdf
Prudent Practices in the Laboratory--the book that has served for decades as the standard for chemical laboratory safety practice--now features updates and new topics. This revised edition has an expanded chapter on chemical management and delves into new areas, such as nanotechnology, laboratory security, and emergency planning. Developed by experts from academia and industry, with specialties in such areas as chemical sciences, pollution prevention, and laboratory safety, Prudent Practices in the Laboratory provides guidance on planning procedures for the handling, storage, and disposal of chemicals. The book offers prudent practices designed to promote safety and includes practical information on assessing hazards, managing chemicals, disposing of wastes, and more. Prudent Practices in the Laboratory will continue to serve as the leading source of chemical safety guidelines for people working with laboratory chemicals: research chemists, technicians, safety officers, educators, and students.
Good Clinical, Laboratory and Manufacturing Practices
Philip Carson,Nigel Dent
Author : Philip Carson,Nigel Dent
Publisher : Royal Society of Chemistry
Page : 656 pages
File Size : 42,5 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847557728
Good Clinical, Laboratory and Manufacturing Practices by Philip Carson,Nigel Dent Pdf
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
The Analysis of Drugs in Biological Fluids 2nd Edition
Joseph Chamberlain
Author : Joseph Chamberlain
Publisher : CRC Press
Page : 366 pages
File Size : 55,5 Mb
Release : 1995-09-18
Category : Medical
ISBN : 0849324920
The Analysis of Drugs in Biological Fluids 2nd Edition by Joseph Chamberlain Pdf
This new edition focuses on a variety of techniques available for the analysis of drugs in biological fluids. Over 150 figures and tables help to describe the latest advances and give examples of their applications. Current chiral analysis methods as well as discussions on the impact of chirality are described. Practical aspects of bioanalytical work, including many examples of laboratory problems not often reported in the scientific literature, are examined in depth.