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Author: Joachim Ermer Publisher: John Wiley & Sons ISBN: 3527604472 Category : Science Languages : en Pages : 418
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Joachim Ermer Publisher: John Wiley & Sons ISBN: 3527604472 Category : Science Languages : en Pages : 418
Book Description
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author: Balwant Singh Publisher: CSIRO PUBLISHING ISBN: 1486305113 Category : Science Languages : en Pages : 401
Book Description
Interest in biochar among soil and environment researchers has increased dramatically over the past decade. Biochar initially attracted attention for its potential to improve soil fertility and to uncouple the carbon cycle, by storing carbon from the atmosphere in a form that can remain stable for hundreds to thousands of years. Later it was found that biochar had applications in environmental and water science, mining, microbial ecology and other fields. Beneficial effects of biochar and its environmental applications cannot be fully realised unless the chemical, physical, structural and surface properties of biochar are known. Currently many of the analytical procedures used for biochar analysis are not well defined, which makes it difficult to choose the right biochar for an intended use and to compare the existing data for biochars. Also, in some instances the use of inappropriate procedures has led to erroneous or inaccurate values for biochars in the scientific literature. Biochar: A Guide to Analytical Methods fills this gap and provides procedures and guidelines for routine and advanced characterisation of biochars. Written by experts, each chapter provides background to a technique or procedure, a stepwise guide to analyses, and includes data for biochars made from a range of feedstocks common to all presented methods. Discussion about the unique features, advantages and disadvantages of a particular technique is an explicit focus of this handbook for biochar analyses. Biochar is primarily intended for researchers, postgraduate students and practitioners who require knowledge of biochar properties. It will also serve as an important resource for researchers, industry and regulatory agencies dealing with biochar.
Author: Chris Burgess Publisher: Royal Society of Chemistry ISBN: 1847552285 Category : Science Languages : en Pages : 98
Book Description
The Analytical Methods Committee of the Royal Society of Chemistry has for many years been involved in national and international efforts to establish a comprehensive framework for achieving appropriate quality in chemical measurement. This handbook attempts to select or define robust procedures that ensure the best use of resources and enable laboratories to generate consistent, reliable data. Written in concise, easy-to-read language and illustrated with worked examples, it is a guide to current best practice and establishes a control framework for the development and validation of laboratory-based analytical methods. Topics include samples and sampling, method selection, equipment calibration and qualification, method development and validation, evaluation of data and statistical approaches for method performance and comparison. Valid Analytical Methods and Procedures will be welcomed by many organisations throughout the world who are required to prove that the validity of their analytical results can be established beyond reasonable doubt.
Author: Darrell R. Jobman Publisher: McGraw-Hill Companies ISBN: Category : Business & Economics Languages : en Pages : 416
Book Description
Comprehensive guide to analytical methods, trading systems, and technical indicators. Explains virtually every major technical approach. Includes contributions from many of the top minds in futures technical analysis, such as Schwager, DeMark, Wilder, Williams, Lane, Hill, et al.
Author: Christopher M. Riley Publisher: Elsevier ISBN: 0080530354 Category : Science Languages : en Pages : 363
Book Description
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Author: Oona McPolin Publisher: Lulu.com ISBN: 0956152813 Category : Medical Languages : en Pages : 154
Book Description
This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Author: Nicholas Cook Publisher: Oxford University Press, USA ISBN: 9780198165088 Category : Music Languages : en Pages : 388
Book Description
This extremely practical introduction to musical analysis explores the factors that give unity and coherence to musical masterpieces. Having first identified and explained the most important analytical methods, Nicholas Cook examines given compositions from the last two hundred years to show how different analytical procedures suit different types of music.
Author: Hermann Mascher Publisher: John Wiley & Sons ISBN: 3527331298 Category : Science Languages : en Pages : 0
Book Description
Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind
Author: Joachim Ermer
Author: Joachim Ermer
Author: Balwant Singh
Author: John V. Crable
Author: Chris Burgess
Author: 
Author: Darrell R. Jobman
Author: Christopher M. Riley
Author: Oona McPolin
Author: Nicholas Cook
Author: Hermann Mascher