Practical Approaches to Method Validation and Essential Instrument Qualification

Practical Approaches to Method Validation and Essential Instrument Qualification PDF Book Detail Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 1118060318
Category : Science
Languages : en
Pages : 416

Book Description
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.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis PDF Book Detail 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.

Plastics Additives

Plastics Additives PDF Book Detail Author: Jan C. J. Bart
Publisher: IOS Press
ISBN: 1586035339
Category : Science
Languages : en
Pages : 825

Book Description
Contains an outline of the principles and characteristics of relevant instrumental techniques, provides an overview of various aspects of direct additive analysis by focusing on an array of applications in R ampD, production, quality control, and technical service.

Advances in Clinical Chemistry

Advances in Clinical Chemistry PDF Book Detail Author:
Publisher: Academic Press
ISBN: 0128171804
Category : Science
Languages : en
Pages : 302

Book Description
Advances in Clinical Chemistry, Volume 90, the latest installment in this internationally acclaimed series, contains chapters authored by world-renowned clinical laboratory scientists, physicians and research scientists. The serial discusses the latest and most up-to-date technologies related to the field of clinical chemistry, and is the benchmark for novel analytical approaches in the clinical laboratory. Provides the most up-to-date technologies in clinical chemistry and clinical laboratory science Authored by world-renowned clinical laboratory scientists, physicians and research scientists Presents the international benchmark for novel analytical approaches in the clinical laboratory

Basic Laboratory Methods for Biotechnology

Basic Laboratory Methods for Biotechnology PDF Book Detail Author: Lisa A. Seidman
Publisher: CRC Press
ISBN: 1000480763
Category : Medical
Languages : en
Pages : 1210

Book Description
Basic Laboratory Methods for Biotechnology, Third Edition is a versatile textbook that provides students with a solid foundation to pursue employment in the biotech industry and can later serve as a practical reference to ensure success at each stage in their career. The authors focus on basic principles and methods while skillfully including recent innovations and industry trends throughout. Fundamental laboratory skills are emphasized, and boxed content provides step by step laboratory method instructions for ease of reference at any point in the students’ progress. Worked through examples and practice problems and solutions assist student comprehension. Coverage includes safety practices and instructions on using common laboratory instruments. Key Features: Provides a valuable reference for laboratory professionals at all stages of their careers. Focuses on basic principles and methods to provide students with the knowledge needed to begin a career in the Biotechnology industry. Describes fundamental laboratory skills. Includes laboratory scenario-based questions that require students to write or discuss their answers to ensure they have mastered the chapter content. Updates reflect recent innovations and regulatory requirements to ensure students stay up to date. Tables, a detailed glossary, practice problems and solutions, case studies and anecdotes provide students with the tools needed to master the content.

Biomarkers Diagnostics and Precision Medicine in the Drug Industry

Biomarkers  Diagnostics and Precision Medicine in the Drug Industry PDF Book Detail Author: Abdel Halim
Publisher: Academic Press
ISBN: 0128161221
Category : Medical
Languages : en
Pages : 294

Book Description
The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations

Process Analytical Technology

Process Analytical Technology PDF Book Detail Author: Katherine A. Bakeev
Publisher: John Wiley & Sons
ISBN: 0470689609
Category : Science
Languages : en
Pages : 576

Book Description
Process Analytical Technology explores the concepts of PAT and its application in the chemical and pharmaceutical industry from the point of view of the analytical chemist. In this new edition all of the original chapters have been updated and revised, and new chapters covering the important topics of sampling, NMR, fluorescence, and acoustic chemometrics have been added. Coverage includes: Implementation of Process Analytical Technologies UV-Visible Spectroscopy for On-line Analysis Infrared Spectroscopy for Process Analytical Applications Process Raman Spectroscopy Process NMR Spectrscopy: Technology and On-line Applications Fluorescent Sensing and Process Analytical Applications Chemometrics in Process Analytical Technology (PAT) On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing NIR Chemical Imaging This volume is an important starting point for anyone wanting to implement PAT and is intended not only to assist a newcomer to the field but also to provide up-to-date information for those who practice process analytical chemistry and PAT. It is relevant for chemists, chemical and process engineers, and analytical chemists working on process development, scale-up and production in the pharmaceutical, fine and specialty chemicals industries, as well as for academic chemistry, chemical engineering, chemometrics and pharmaceutical science research groups focussing on PAT. Review from the First Edition “The book provides an excellent first port of call for anyone seeking material and discussions to understand the area better. It deserves to be found in every library that serves those who are active in the field of Process Analytical Technology.”—Current Engineering Practice

Analytical Techniques in Biosciences

Analytical Techniques in Biosciences PDF Book Detail Author: Chukwuebuka Egbuna
Publisher: Academic Press
ISBN: 0128227990
Category : Science
Languages : en
Pages : 300

Book Description
Analytical Techniques in Biosciences: From Basics to Applications presents comprehensive and up-to-date information on the various analytical techniques obtainable in bioscience research laboratories across the world. This book contains chapters that discuss the basic bioanalytical protocols and sample preparation guidelines. Commonly encountered analytical techniques, their working principles, and applications were presented. Techniques, considered in this book, include centrifugation techniques, electrophoretic techniques, chromatography, titrimetry, spectrometry, and hyphenated techniques. Subsequent chapters emphasize molecular weight determination and electroanalytical techniques, biosensors, and enzyme assay protocols. Other chapters detail microbial techniques, statistical methods, computational modeling, and immunology and immunochemistry. The book draws from experts from key institutions around the globe, who have simplified the chapters in a way that will be useful to early-stage researchers as well as advanced scientists. It is also carefully structured and integrated sequentially to aid flow, consistency, and continuity. This is a must-have reference for graduate students and researchers in the field of biosciences. Presents basic analytical protocols and sample-preparation guidelines Details the various analytical techniques, including centrifugation, spectrometry, chromatography, and titrimetry Describes advanced techniques such as hyphenated techniques, electroanalytical techniques, and the application of biosensors in biomedical research Presents biostatistical tools and methods and basic computational models in biosciences

Biomarkers for Traumatic Brain Injury

Biomarkers for Traumatic Brain Injury PDF Book Detail Author: Alan H.B. Wu
Publisher: Academic Press
ISBN: 0128167300
Category : Medical
Languages : en
Pages : 486

Book Description
Biomarkers for Traumatic Brain Injury provides a comprehensive overview on the selection and implementation of serum-based and saliva-based biomarkers for traumatic brain injury. The book presents an economic analysis for implementing TBI biomarkers into clinical practice. In addition, it discusses the analytical tools needed to implement TBI biomarkers, including specifications for testing instruments and interpretative software. Neurologists, emergency department physicians, intensivists, and clinical laboratorians will find this book a great resource from which to familiarize themselves with the issues and processes regarding TBI biomarkers. Approximately 2 million people in the U.S. sustain a traumatic brain injury (TBI) each year with over 250,000 hospitalizations and 50,000 deaths. There has been a significant rise in interest in diagnosing mild concussions, particularly in the sports world. While imaging has been the gold standard, these procedures are costly and not always available. There is great potential in using serum-based biomarkers, hence the book seeks to enlighten readers on new possibilities. Offers strategies for the selection and implementation of traumatic brain injury biomarkers Discusses the importance of autoantibodies and post translational modifications for TBI Covers the analytical tools needed to implement TBI biomarkers, including the specifications for testing instruments and interpretative software

Leveraging Applications of Formal Methods Verification and Validation

Leveraging Applications of Formal Methods  Verification and Validation PDF Book Detail Author: Tiziana Margaria
Publisher: Springer Science & Business Media
ISBN: 3540884793
Category : Computers
Languages : en
Pages : 869

Book Description
This volume contains the conference proceedings of ISoLA 2008, the Third International Symposium on Leveraging Applications of Formal Methods, Verification and Validation, which was held in Porto Sani (Kassandra, Chalkidiki), Greece during October 13–15, 2008, sponsored by EASST and in cooperation with the IEEE Technical Committee on Complex Systems. Following the tradition of its forerunners in 2004 and 2006 in Cyprus, and the ISoLA Workshops in Greenbelt (USA) in 2005 and in Poitiers (France) in 2007, ISoLA 2008 provided a forum for developers, users, and researchers to discuss issues related to the adoption and use of rigorous tools and methods for the specification, analysis, verification, certification, construction, test, and maintenance of systems from the point of view of their different application domains. Thus, the ISoLA series of events serves the purpose of bridging the gap between designers and developers of rigorous tools, and users in engineering and in other disciplines, and to foster and exploit synergetic relationships among scientists, engineers, software developers, decision makers, and other critical thinkers in companies and organizations. In p- ticular, by providing a venue for the discussion of common problems, requirements, algorithms, methodologies, and practices, ISoLA aims at supporting researchers in their quest to improve the utility, reliability, flexibility, and efficiency of tools for building systems, and users in their search for adequate solutions to their problems.

Food Safety and Preservation

Food Safety and Preservation PDF Book Detail Author: Alexandru Mihai Grumezescu
Publisher: Academic Press
ISBN: 0128149574
Category : Technology & Engineering
Languages : en
Pages : 696

Book Description
Food Safety and Preservation: Modern Biological Approaches to Improving Consumer Health explores the most recent and investigated hot topics in food safety, microbial contamination, food-borne diseases and advanced preservation methods. It brings together the significant, evidence-based scientific progress of various approaches to improve the safety and quality of foods, also offering solutions to help address food industry challenges. Recent studies and technological advancements in biological control are presented to control foodborne pathogens. In addition, analytical methods for reducing potential biological hazards make this book essential to researchers, scientists, technologists and grad students. Covers all aspects of food contamination, from food degradation, to food-borne diseases Examines validated, biological control approaches to reduce microbial and chemical contamination Includes detailed discussions of risk and safety assessments in food preservation

Molecular Microbiology

Molecular Microbiology PDF Book Detail Author: David H. Persing
Publisher: John Wiley & Sons
ISBN: 1555819079
Category : Science
Languages : en
Pages : 835

Book Description
Presenting the latest molecular diagnostic techniques in one comprehensive volume The molecular diagnostics landscape has changed dramatically since the last edition of Molecular Microbiology: Diagnostic Principles and Practice in 2011. With the spread of molecular testing and the development of new technologies and their opportunities, laboratory professionals and physicians more than ever need a resource to help them navigate this rapidly evolving field. Editors David Persing and Fred Tenover have brought together a team of experienced researchers and diagnosticians to update this third edition comprehensively, to present the latest developments in molecular diagnostics in the support of clinical care and of basic and clinical research, including next-generation sequencing and whole-genome analysis. These updates are provided in an easy-to-read format and supported by a broad range of practical advice, such as determining the appropriate type and quantity of a specimen, releasing and concentrating the targets, and eliminating inhibitors. Molecular Microbiology: Diagnostic Principles and Practice Presents the latest basic scientific theory underlying molecular diagnostics Offers tested and proven applications of molecular diagnostics for the diagnosis of infectious diseases, including point-of-care testing Illustrates and summarizes key concepts and techniques with detailed figures and tables Discusses emerging technologies, including the use of molecular typing methods for real-time tracking of infectious outbreaks and antibiotic resistance Advises on the latest quality control and quality assurance measures Explores the increasing opportunities and capabilities of information technology Molecular Microbiology: Diagnostic Principles and Practice is a textbook for molecular diagnostics courses that can also be used by anyone involved with diagnostic test selection and interpretation. It is also a useful reference for laboratories and as a continuing education resource for physicians.

Validation in Chemical Measurement

Validation in Chemical Measurement PDF Book Detail Author: Paul De Bièvre
Publisher: Springer Science & Business Media
ISBN: 9783540207887
Category : Science
Languages : en
Pages : 166

Book Description
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.

Cytogenetic Laboratory Management

Cytogenetic Laboratory Management PDF Book Detail Author: Susan Mahler Zneimer
Publisher: John Wiley & Sons
ISBN: 1119069777
Category : Science
Languages : en
Pages : 789

Book Description
Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests and FDA guidelines for laboratory developed tests, and pre-clinical validation study designs. The second focus of the book describes best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides step-wise standard operating procedures for chromosomal, FISH and microarray-based tests, including pre-analytic, analytic and post-analytic steps in testing, and divided into categories by specimen type, and test-type. All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory. Providing both a wealth of information on laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians world-wide in the field of laboratory testing and genetics testing in particular. This book gives the essentials of: Developing and implementing good quality management programs in laboratories Understanding design control of tests and pre-clinical validations studies and reports FDA guidelines for laboratory developed tests Use of reagents, instruments and equipment Cost of testing assessment and process improvement using Six Sigma methodology Staffing training and competency objectives Complete training programs for molecular and cytogenetic technologists Standard operating procedures for all components of chromosomal analysis, FISH and microarray testing of different specimen types This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements.

Computer Simulation Validation

Computer Simulation Validation PDF Book Detail Author: Claus Beisbart
Publisher: Springer
ISBN: 3319707663
Category : Computers
Languages : en
Pages : 1074

Book Description
This unique volume introduces and discusses the methods of validating computer simulations in scientific research. The core concepts, strategies, and techniques of validation are explained by an international team of pre-eminent authorities, drawing on expertise from various fields ranging from engineering and the physical sciences to the social sciences and history. The work also offers new and original philosophical perspectives on the validation of simulations. Topics and features: introduces the fundamental concepts and principles related to the validation of computer simulations, and examines philosophical frameworks for thinking about validation; provides an overview of the various strategies and techniques available for validating simulations, as well as the preparatory steps that have to be taken prior to validation; describes commonly used reference points and mathematical frameworks applicable to simulation validation; reviews the legal prescriptions, and the administrative and procedural activities related to simulation validation; presents examples of best practice that demonstrate how methods of validation are applied in various disciplines and with different types of simulation models; covers important practical challenges faced by simulation scientists when applying validation methods and techniques; offers a selection of general philosophical reflections that explore the significance of validation from a broader perspective. This truly interdisciplinary handbook will appeal to a broad audience, from professional scientists spanning all natural and social sciences, to young scholars new to research with computer simulations. Philosophers of science, and methodologists seeking to increase their understanding of simulation validation, will also find much to benefit from in the text.