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| Author | : Mark Stauffer |
| Publisher | : BoD – Books on Demand |
| Total Pages | : 176 |
| Release | : 2018-04-25 |
| Genre | : Science |
| ISBN | : 1789230845 |
Download Calibration and Validation of Analytical Methods Book in PDF, ePub and Kindle
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.
| Author | : Mark T. Stauffer |
| Publisher | : |
| Total Pages | : 174 |
| Release | : 2018 |
| Genre | : Chemistry, Analytic |
| ISBN | : 9781789230857 |
Download Calibration and Validation of Analytical Methods - A Sampling of Current Approaches Book in PDF, ePub and Kindle
This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, ""Introduction,"" contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 ""Calibration Approaches"" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, ""Validation Approaches,"" which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.
| Author | : Chung Chow Chan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 320 |
| Release | : 2004-04-23 |
| Genre | : Science |
| ISBN | : 047146371X |
Download Analytical Method Validation and Instrument Performance Verification Book in PDF, ePub and Kindle
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
| Author | : Chung Chow Chan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 363 |
| Release | : 2011-03-01 |
| Genre | : Science |
| ISBN | : 1118060318 |
Download Practical Approaches to Method Validation and Essential Instrument Qualification Book in PDF, ePub and Kindle
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
| Author | : Michael E. Swartz |
| Publisher | : CRC Press |
| Total Pages | : 218 |
| Release | : 2012-04-24 |
| Genre | : Medical |
| ISBN | : 142001448X |
Download Handbook of Analytical Validation Book in PDF, ePub and Kindle
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
| Author | : Christopher Burgess |
| Publisher | : |
| Total Pages | : 87 |
| Release | : 2000 |
| Genre | : Science |
| ISBN | : 9781847552280 |
Download Valid Analytical Methods and Procedures Book in PDF, ePub and Kindle
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 | : Max Feinberg |
| Publisher | : John Wiley & Sons |
| Total Pages | : 341 |
| Release | : 2024-02-16 |
| Genre | : Science |
| ISBN | : 3527845267 |
Download Quantification, Validation and Uncertainty in Analytical Sciences Book in PDF, ePub and Kindle
Quantification, Validation and Uncertainty in Analytical Sciences Companion guide explaining all processes in measuring uncertainty in quantitative analytical results Quantification, Validation and Uncertainty in Analytical Sciences provides basic and expert knowledge by building on the sequence of operations starting from the quantification in analytical sciences by defining the analyte and linking it to the calibration function. Proposing a comprehensive approach to MU (Measurement Uncertainty) estimation, it empowers the reader to apply Method Accuracy Profile (MAP) efficiently as a statistical tool in measuring uncertainty. The text elucidates several examples and template worksheets explaining the theoretical aspects of the procedure and includes novel method validation procedures that can accurately estimate the data obtained in measurements. It also enables the reader to provide practical insights to improve decision making by accurately evaluating and comparing different analytical methods. Brings together an interdisciplinary approach with statistical tools and algorithms applied in analytical chemistry and written by two international experts with long-standing experience in the field of Analytical measurements and Uncertainty, Quantification, Validation and Uncertainty in Analytical Sciences includes information on: The know-how of methods in an analytical laboratory, effective usage of a spurious measurement and methods to estimate errors. Quantification, calibration, precision, trueness, MAP addons, estimating MU for analytical sciences, and uncertainty functions Employing measurement uncertainty, sampling uncertainty, quantification limits, and sample conformity assessment Decision making, uncertainty and standard addition method, and accuracy profile for method comparison Quantification, Validation and Uncertainty in Analytical Sciences is an ideal resource for every individual quantifying or studying analytes. With several chapters dedicated to MU’s practical use in decision making demonstrating its advantages, the book is primarily intended for professional analysts, although researchers and students will also find it of interest.
| Author | : Paweł Kościelniak |
| Publisher | : John Wiley & Sons |
| Total Pages | : 388 |
| Release | : 2023-02-24 |
| Genre | : Science |
| ISBN | : 3527831126 |
Download Calibration in Analytical Science Book in PDF, ePub and Kindle
Calibration in Analytical Science Designed to help analytical chemists save time and money by selecting the best calibration method in a quality control, substance monitoring, or research setting Univariate analytical calibration is a vital step in every chemical procedure that involves determining the identity or concentration of a particular substance. Depending on the type of instrument and measurement, analytical chemists need to follow different calibration strategies and protocols to ensure their instruments yield accurate readings. Calibration in Analytical Science systematically classifies and describes a wide range of calibration methods and procedures based on mathematical and empirical models for use in qualitative and quantitative analysis. Focusing on the chemical aspects of analytical calibration, this much-needed reference uses a set of equipment-independent terms and definitions that are easily transferable to the calibration strategies of any analytical process. The theoretical basis for calibration of each analytical mode is described and applied to common analytical tasks of increasing levels of difficulty and complexity. Throughout the book, the author illustrates how to combine different calibration approaches to create new calibration strategies with extended capabilities. Describes different calibration methods and procedures for determining the nature and quantity of sample components in different ways Classifies various calibration methods in both qualitative and quantitative analysis Demonstrates how the random and systematic errors of an analytical method can be minimized by the proper calibration strategy Discusses current theoretical and methodological questions in calibration research Highlights how calibration approaches can diagnose, evaluate, and eliminate analytical errors Includes a concluding chapter on the contribution of calibration to the greening of analytical chemistry Calibration in Analytical Science: Methods and Procedures is a must-have reference for analytical chemists working in academia and industry, chemists of various specialties involved in chemical analysis, and advanced undergraduate and graduate students taking courses in advanced analytical chemistry.
| Author | : Christopher Burgess |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 102 |
| Release | : 2000 |
| Genre | : Education |
| ISBN | : 9780854044825 |
Download Valid Analytical Methods and Procedures Book in PDF, ePub and Kindle
This handbook defines procedures that ensure the best use of resources and enables laboratories to generate consistent, reliable data. Written in a concise, easy-to-read language and illustrated with worked examples, this is a guide to the best practices and methods. A control framework for the development and validation of laboratory-based analytical methods is established. Particular attention is given to the sample, methods chosen, instrumentation, personnel, and calculations used.
| Author | : Paul De Bièvre |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 176 |
| Release | : 2005-12-06 |
| Genre | : Science |
| ISBN | : 3540270345 |
Download Validation in Chemical Measurement Book in PDF, ePub and Kindle
The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance." They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.
