Handbook Of Analytical Validation

Author : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 142001448X
Total Pages : 218 pages
Book Rating : 4.88/5 ( download)

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Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128203331
Total Pages : 225 pages
Book Rating : 4.30/5 ( download)

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Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.70/5 ( download)

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Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Michael E. Swartz
Publisher : CRC Press
ISBN 13 : 1482229773
Total Pages : 95 pages
Book Rating : 4.76/5 ( download)

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Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Georg Hempel
Publisher : Elsevier
ISBN 13 : 0080530540
Total Pages : 379 pages
Book Rating : 4.43/5 ( download)

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Download or read book Drug Monitoring and Clinical Chemistry written by Georg Hempel and published by Elsevier. This book was released on 2004-05-15 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Monitoring and Clinical Chemistry, the 5th volume in the Handbook of Analytical Separations series, gives an overview about methods to analyse drugs in biological fluids. The most widely used methods to analyse drugs in biological fluids. i.e. chromatographic methods, CE and immunoassays are described in detail. For important drugs, an overview about the methods available and a comparison of the techniques should be given to enable the reader to choose the right method depending on laboratory equipment, staff, the aim of the investigation etc. Other general aspects important for conducting therapeutic drug monitoring or pharmacokinetics studies are also covered, i.e. sample preparation, validation of the analytical methods and pharmacokinetic methods for interpreting the data. Areas where therapeutic drug monitoring is used frequently such as antibiotics, immunosuppressant drugs, antipsychotic and anticancer drugs will be discussed in detail. In addition, the important field of phenotyping and genotyping for therapy optimisation with special focus on real-life applications is also covered. The book contains important information for analyst working on drug analysis in clinical chemistry, hospital pharmacists involved in therapeutic drug monitoring, other pharmacists, chemists or physicians working on pharmacokinetic studies in industry or academia. In contrast to other books in this field, this book provides up-to-date information regarding both methodology and clinical applications. For the applications, only fields are described where therapeutic drug monitoring is used in clinical routine and provides benefit to the patients. Overview of all important field where therapeutic drug monitoring is applied All relevant analytical and computational methods are discussed Written by experts with a lot of practical experience in the field

Author : Satinder Ahuja
Publisher : Academic Press
ISBN 13 : 0123759811
Total Pages : 604 pages
Book Rating : 4.18/5 ( download)

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Download or read book Handbook of Modern Pharmaceutical Analysis written by Satinder Ahuja and published by Academic Press. This book was released on 2010-11-11 with total page 604 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Author : Frank Jaksch
Publisher : American Pharmacists Association (APhA)
ISBN 13 :
Total Pages : 232 pages
Book Rating : 4.38/5 ( download)

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Download or read book Handbook of Analytical Methods for Dietary Supplements written by Frank Jaksch and published by American Pharmacists Association (APhA). This book was released on 2005 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Highlights include: an in-depth review of how analytical methods for dietary supplements are validated, including information on what buyers of analytical services should look for and how they should assess the quality of results. This review is useful to those validating their own in-house methods, as well; 38 monographs on dietary ingredients most commonly used to produce dietary supplements. Each monograph follows a standard format for quick reference; chemical names, formulas, and structures, along with information on solubility and other physical and chemical data; a description of common uses for each dietary supplement and its mode of action; discussion of reference standards and/or marker compounds used; information and directions for using various component-specific methods; and chromatography specifications and representative chromatograms, when available."--BOOK JACKET.

Author : James O. Westgard
Publisher : AACC Press
ISBN 13 : 9781886958197
Total Pages : 292 pages
Book Rating : 4.9X/5 ( download)

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Download or read book Basic Method Validation written by James O. Westgard and published by AACC Press. This book was released on 2003-01-01 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.

Author : Georg Hempel
Publisher : Elsevier
ISBN 13 : 0444640673
Total Pages : 380 pages
Book Rating : 4.73/5 ( download)

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Download or read book Methods of Therapeutic Drug Monitoring Including Pharmacogenetics written by Georg Hempel and published by Elsevier. This book was released on 2019-10-17 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods of Therapeutic Drug Monitoring Including Pharmacogenetics, Second Edition, Volume Seven in the Handbook of Analytical Separations series, covers all aspects of drug monitoring, including laboratory work, pharmacokinetic analysis and clinical aspects, thus enabling readers from different fields to understand the whole process of therapeutic drug monitoring and how to avoid common pitfalls. The book contains analytical techniques for the quantification of drugs, along with pharmacogenetic and pharmacogenomic methods. Also included are updates on sample preparation, including dried blood spot technology and microextraction methods. In addition, the book includes new drugs, such as tyrosine kinase inhibitors and the monitoring of immunosuppressant drugs. Presents a unique, interdisciplinary approach that appeals to a wide range of users Written by authors from international labs, providing a global perspective that can be applied in various regulatory environments Features additional therapeutic drugs to reflect the rising number of immunocompromised patients Includes a new mass spectroscopic methods chapter to capture the frequent use in TDM and the improved availability of LC-MS across laboratories

Author : Christopher Burgess
Publisher : Royal Society of Chemistry
ISBN 13 : 9780854044825
Total Pages : 102 pages
Book Rating : 4.25/5 ( download)

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Download or read book Valid Analytical Methods and Procedures written by Christopher Burgess and published by Royal Society of Chemistry. This book was released on 2000 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.