Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bioanalytics written by Friedrich Lottspeich and published by John Wiley & Sons. This book was released on 2018-03-08 with total page 1137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analytical methods are the essential enabling tools of the modern biosciences. This book presents a comprehensive introduction into these analytical methods, including their physical and chemical backgrounds, as well as a discussion of the strengths and weakness of each method. It covers all major techniques for the determination and experimental analysis of biological macromolecules, including proteins, carbohydrates, lipids and nucleic acids. The presentation includes frequent cross-references in order to highlight the many connections between different techniques. The book provides a bird's eye view of the entire subject and enables the reader to select the most appropriate method for any given bioanalytical challenge. This makes the book a handy resource for students and researchers in setting up and evaluating experimental research. The depth of the analysis and the comprehensive nature of the coverage mean that there is also a great deal of new material, even for experienced experimentalists. The following techniques are covered in detail: - Purification and determination of proteins - Measuring enzymatic activity - Microcalorimetry - Immunoassays, affinity chromatography and other immunological methods - Cross-linking, cleavage, and chemical modification of proteins - Light microscopy, electron microscopy and atomic force microscopy - Chromatographic and electrophoretic techniques - Protein sequence and composition analysis - Mass spectrometry methods - Measuring protein-protein interactions - Biosensors - NMR and EPR of biomolecules - Electron microscopy and X-ray structure analysis - Carbohydrate and lipid analysis - Analysis of posttranslational modifications - Isolation and determination of nucleic acids - DNA hybridization techniques - Polymerase chain reaction techniques - Protein sequence and composition analysis - DNA sequence and epigenetic modification analysis - Analysis of protein-nucleic acid interactions - Analysis of sequence data - Proteomics, metabolomics, peptidomics and toponomics - Chemical biology
Download or read book Element Analysis of Biological Samples written by G. Venkatesh Iyengar and published by CRC Press. This book was released on 1997-10-02 with total page 278 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the development of innovative new analytical techniques for biological trace element research, today's trace element investigators face formidable obstacles to obtaining reliable data. This complete reference identifies and assesses the challenges the analyst encounters at each stage of an analysis, and discusses the effects of various techniques on the sample. Three internationally recognized scientists and authors consider the effects of the numerous collection, storage, and sample preparatory techniques used in sample analysis. Proper analytical quality control, including such critical factors as sampling and sample preparation, specimen preservation and storage, and ashing, is examined. The book also looks at sample preparation methods unique to various instruments and speciation chemistry issues, and examines the link between chemical analysis and specimen banking. A previously unrecognized source of error, presampling factors, is also discussed.
Download or read book NIOSH Manual of Analytical Methods NIOSH monitoring methods written by John V. Crable and published by . This book was released on 1977 with total page 818 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Download or read book Analysis of Biological Development written by Klaus Kalthoff and published by McGraw-Hill Science, Engineering & Mathematics. This book was released on 2001 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text, now available in full color, presents developmental biology as an ongoing process of enquiry, giving students a sense of the ways developmental biologists gain knowledge and a taste of the challenges ahead. The first part of the text focuses on the classical methods of analysis and the stages of embryonic development from gametogenesis to histogenesis. Part Two introduces the genetic and molecular analysis of development. The final part combines classical and modern types of analysis towards the investigation of long standing problems in development. Key experiments are described throughout to reinforce the relationship between scientific models and experimental data.
Download or read book Recent Advances in Analytical Chemistry written by Muharrem Ince and published by BoD – Books on Demand. This book was released on 2019-04-10 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on recent and future trends in analytical methods and provides an overview of analytical chemistry. As a comprehensive analytical chemistry book, it takes a broad view of the subject and integrates a wide variety of approaches. The book provides separation approaches and method validation, as well as recent developments and applications in analytical chemistry. It is written primarily for researchers in the fields of analytical chemistry, environmental chemistry, and applied chemistry. The aim of the book is to explain the subject, clarify important studies, and compare and develop new and groundbreaking applications. Written by leading experts in their respective areas, the book is highly recommended for professionals interested in analytical chemistry because it provides specific and comprehensive examples.
Download or read book Handbook of Drug Monitoring Methods written by Amitava Dasgupta and published by Springer Science & Business Media. This book was released on 2007-10-23 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a handbook style with specific methods and tips on eliminating false positive and false negative results, this book is a practical guide to the detailed mechanisms of such occurrences.
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.
Download or read book Biological Sequence Analysis written by Richard Durbin and published by Cambridge University Press. This book was released on 1998-04-23 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Probabilistic models are becoming increasingly important in analysing the huge amount of data being produced by large-scale DNA-sequencing efforts such as the Human Genome Project. For example, hidden Markov models are used for analysing biological sequences, linguistic-grammar-based probabilistic models for identifying RNA secondary structure, and probabilistic evolutionary models for inferring phylogenies of sequences from different organisms. This book gives a unified, up-to-date and self-contained account, with a Bayesian slant, of such methods, and more generally to probabilistic methods of sequence analysis. Written by an interdisciplinary team of authors, it aims to be accessible to molecular biologists, computer scientists, and mathematicians with no formal knowledge of the other fields, and at the same time present the state-of-the-art in this new and highly important field.
Download or read book Analysis Of Biological Data A Soft Computing Approach written by Sanghamitra Bandyopadhyay and published by World Scientific. This book was released on 2007-09-03 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioinformatics, a field devoted to the interpretation and analysis of biological data using computational techniques, has evolved tremendously in recent years due to the explosive growth of biological information generated by the scientific community. Soft computing is a consortium of methodologies that work synergistically and provides, in one form or another, flexible information processing capabilities for handling real-life ambiguous situations. Several research articles dealing with the application of soft computing tools to bioinformatics have been published in the recent past; however, they are scattered in different journals, conference proceedings and technical reports, thus causing inconvenience to readers, students and researchers.This book, unique in its nature, is aimed at providing a treatise in a unified framework, with both theoretical and experimental results, describing the basic principles of soft computing and demonstrating the various ways in which they can be used for analyzing biological data in an efficient manner. Interesting research articles from eminent scientists around the world are brought together in a systematic way such that the reader will be able to understand the issues and challenges in this domain, the existing ways of tackling them, recent trends, and future directions. This book is the first of its kind to bring together two important research areas, soft computing and bioinformatics, in order to demonstrate how the tools and techniques in the former can be used for efficiently solving several problems in the latter.
Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.
Download or read book Data Analysis in Molecular Biology and Evolution written by Xuhua Xia and published by Springer Science & Business Media. This book was released on 2007-05-08 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data Analysis in Molecular Biology and Evolution introduces biologists to DAMBE, a proprietary, user-friendly computer program for molecular data analysis. The unique combination of this book and software will allow biologists not only to understand the rationale behind a variety of computational tools in molecular biology and evolution, but also to gain instant access to these tools for use in their laboratories. Data Analysis in Molecular Biology and Evolution serves as an excellent resource for advanced level undergraduates or graduates as well as for professionals working in the field.
Download or read book Proteomic Profiling and Analytical Chemistry written by Pawel Ciborowski and published by Elsevier. This book was released on 2016-03-02 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteomic Profiling and Analytical Chemistry: The Crossroads, Second Edition helps scientists without a strong background in analytical chemistry to understand principles of the multistep proteomic experiment necessary for its successful completion. It also helps researchers who do have an analytical chemistry background to break into the proteomics field. Highlighting points of junction between proteomics and analytical chemistry, this resource links experimental design with analytical measurements, data analysis, and quality control. This targeted point of view will help both biologists and chemists to better understand all components of a complex proteomic study. The book provides detailed coverage of experimental aspects such as sample preparation, protein extraction and precipitation, gel electrophoresis, microarrays, dynamics of fluorescent dyes, and more. The key feature of this book is a direct link between multistep proteomic strategy and quality control routinely applied in analytical chemistry. This second edition features a new chapter on SWATH-MS, substantial updates to all chapters, including proteomic database search and analytical quantification, expanded discussion of post-hoc statistical tests, and additional content on validation in proteomics. - Covers the analytical consequences of protein and peptide modifications that may have a profound effect on how and what researchers actually measure - Includes practical examples illustrating the importance of problems in quantitation and validation of biomarkers - Helps in designing and executing proteomic experiments with sound analytics
Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Analytical Techniques in Biochemistry and Molecular Biology written by Rajan Katoch and published by Springer Science & Business Media. This book was released on 2011-07-19 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in biochemistry now allow us to control living systems in ways that were undreamt of a decade ago. This volume guides researchers and students through the full spectrum of experimental protocols used in biochemistry, plant biology and biotechnology.
