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Author: David M. Bliesner
Publisher: John Wiley & Sons
ISBN: 0470042192
Category : Science
Languages : en
Pages : 301
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Book Description
All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.
Author: David M. Bliesner
Publisher: John Wiley & Sons
ISBN: 0470042192
Category : Science
Languages : en
Pages : 301
Get Book
Book Description
All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.
Author: David M. Bliesner
Publisher: Wiley-Interscience
ISBN: 9780471741473
Category : Science
Languages : en
Pages : 0
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Book Description
All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal or no complications. This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well. Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Method evaluation and further method development Final method development and trial method validation Formal method validation and report generation Formal data review and report issuance Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided. Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success. All of the templates are also included on a supplementary support site, enabling readers to easily work with and customize them. For scientists and technicians new to method validation, this guide provides all the information and tools needed to develop a top-quality system. For those experienced with method validation, the guide helps to upgrade and improve existing systems.
Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 1482229773
Category : Science
Languages : en
Pages : 95
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Book Description
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Author: Satish Y. Gabhe
Publisher: diplom.de
ISBN: 3954898071
Category : Science
Languages : en
Pages : 108
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Book Description
This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.
Author: K.L. Barnett
Publisher: Elsevier Inc. Chapters
ISBN: 0128071087
Category : Science
Languages : en
Pages : 688
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Book Description
Method-validation experiments are intended to demonstrate that an analytical method will yield acceptable method performance. Several works provide guidance outlining requirements for method validation, and numerous articles demonstrate how to perform LC method validation according to these guidelines. While traditional validation experiments provide useful information about method characteristics, they do not directly address an important feature of an analytical method: agreement of the measured value with the true value. In this chapter, traditional method validation guidance and the associated method characteristics are discussed. In addition, recent approaches that incorporate risk and a more rigorous assessment of method variability are also briefly described.
Author: A Fajgelj
Publisher: Royal Society of Chemistry
ISBN: 1847551750
Category : Science
Languages : en
Pages : 317
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Book Description
Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
Author: Roger Bertholf
Publisher: John Wiley & Sons
ISBN: 0470023104
Category : Science
Languages : en
Pages : 308
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Book Description
This book aims to fill the gap that exists between theoretical treatments of chromatography, and clinical chemistry and toxicology texts, which focus almost exclusively on clinical relevance and applications. Chromatography has a vast array of clinical applications, and though the chromatographic methods were first introduced decades ago, new applications of this technology are being used to explore previously inaccessible frontiers in clinical diagnostics and toxicological testing. An up-to-date book devoted to clinical and toxicological applications of chromatographic methods will serve as an instructional and reference text, useful to students, laboratory technicians, and researchers.
Author: Nelu Grinberg
Publisher: CRC Press
ISBN: 1482218682
Category : Medical
Languages : en
Pages : 975
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Book Description
This handbook is a guide for workers in analytical chemistry who need a starting place for information about a specific instrumental technique. It gives a basic introduction to the techniques and provides leading references on the theory and methodology for an instrumental technique. This edition thoroughly expands and updates the chapters to include concepts, applications, and key references from recent literature. It also contains a new chapter on process analytical technology.
Author: Tuulia Hyotylainen
Publisher: Royal Society of Chemistry
ISBN: 1849737274
Category : Science
Languages : en
Pages : 350
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Book Description
The concept of a metabolic profile was introduced in 1971, when gas chromatography demonstrated a range of compounds present in human samples. Now termed metabolomics, the field is still emerging, and chromatography remains an essential tool for determining metabolites in a living system. This is the first book to present the chromatographic techniques used in metabolomics in a fundamental way. Sample preparation and quality control are described in detail, and all forms of chromatography applied to metabolomics are included. The editors present guidelines on selecting the most appropriate methodology, making the book an accessible guide to anyone entering the field. Handling data and applications are also described. This is an essential handbook for any laboratory looking to embark on a metabolomics research programme and includes the fundamentals of chromatography alongside the latest developments in the field.
Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 142001448X
Category : Medical
Languages : en
Pages : 220
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Book Description
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti
