Download or read book Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of LC MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.
Download or read book A Survival Guide for Research Scientists written by Ratna Tantra and published by Springer Nature. This book was released on 2019-08-31 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research scientists play a pivotal role in society. Their passion for science will drive them forward, leading to new discoveries that will ultimately make the world a better place. Unfortunately, as the professional environment becomes more and more competitive, research scientists today cannot just rely on technical knowledge to carve successful careers. Besides technical skills, they will need to acquire other skills, such as how to communicate their science to the outside world. A Survival Guide for Research Scientists is a one-stop-shop that will help you to develop those core skills not often taught at school or university. The book has been written by an author with more than 20 years of scientific research experience (across different scientific disciplines). She has not only been a research scientist but also a writer, a consultant, a sole-trader and a project manager. A Survival Guide for Research Scientists takes on a holistic approach in order to help you pave the way for success. As such, it features practical guidelines on how to: • conduct your scientific research (how to: do literature review, design experiments, adopt best practice, ensure health and safety, etc.). • write and edit (reports, bid proposals, peer review publications, etc). • interact with the outside world (be a team leader, manage a project, network, deal with difficult people, do presentations, organise meetings, etc.). • look after your career (and get your dream job). • look after yourself (and how to manage stress). • look for a job (develop your CV, prepare for interviews, etc.). • become self-employed (and achieve business success). • deal with redundancy (and move forward in life, etc) Whatever your scientific background may be, this book is the perfect accompaniment, to guide you at every stage of your career.
Download or read book Analytical Chemistry written by Gary D. Christian and published by John Wiley & Sons. This book was released on 2013-10-07 with total page 852 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 7th Edition of Gary Christian's Analytical Chemistry focuses on more in-depth coverage and information about Quantitative Analysis (aka Analytical Chemistry) and related fields. The content builds upon previous editions with more enhanced content that deals with principles and techniques of quantitative analysis with more examples of analytical techniques drawn from areas such as clinical chemistry, life sciences, air and water pollution, and industrial analyses.
Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Download or read book Biophysics for Therapeutic Protein Development written by Linda O. Narhi and published by Springer Science & Business Media. This book was released on 2013-02-26 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Download or read book Particles and Nanoparticles in Pharmaceutical Products written by Henk G. Merkus and published by Springer. This book was released on 2018-09-06 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited volume brings together the expertise of numerous specialists on the topic of particles – their physical, chemical, pharmacological and toxicological characteristics – when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.
Download or read book Metrology and Standardization for Nanotechnology written by Elisabeth Mansfield and published by John Wiley & Sons. This book was released on 2017-01-20 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the promotion of global trading and the reduction of potential risks, the role of international standardization of nanotechnologies has become more and more important. This book gives an overview of the current status of nanotechnology including the importance of metrology and characterization at the nanoscale, international standardization of nanotechnology, and industrial innovation of nano-enabled products. First the field of nanometrology, nanomaterial standardization and nanomaterial innovation is introduced. Second, major concepts in analytical measurements are given in order to provide a basis for the reliable and reproducible characterization of nanomaterials. The role of standards organizations are presented and finally, an overview of risk management and the commercial impact of metrology and standardization for industrial innovations.
Download or read book From Herbs to Healing written by Éva Szöke and published by Springer Nature. This book was released on 2023-01-17 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the twenty-first century Pharmacognosy was transformed into a molecular science building on classic botanical and modern chemical knowledge, leading to a better understanding of the complex molecular effect - structure relationships and interactions required for the development of new drugs based on biologically active plant substances.The work demonstrates the place of phytotherapy in healing, the role of herbs in complementary and traditional therapy, and research strategies for the development of drugs of natural plant origin.This book is primarily designed for scientific researchers, but is also very useful for undergraduate and postgraduate students in their professional training. As this book discusses herbs from all over the world, it is specifically drafted to be useful not only in Hungary and Europe, but also for people in other continents as an English language encyclopaedia of medicinal plants and their biologically active compounds.
Download or read book Biochemical Pathways and Environmental Responses in Plants Part A written by and published by Elsevier. This book was released on 2022-10-22 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biochemical Pathways and Environmental Responses in Plants, Part A, Volume 676 in the Methods in Enzymology series highlights new advances in the field with this new volume presenting interesting chapters on topics such as Structure, function, and engineering of plant polyketide synthases, A sensitive LC-MS/MS assay for enzymatic characterization of methylthioalkylmalate synthase involved in glucosinolate side-chain elongation, Assaying formate-tetrahydrofolate ligase with monoglutamylated and polyglutamylated substrates using a fluorescence-HPLC based assay, An Approach to Nearest Neighbor Analysis of Pigmented Protein Complexes by Using Chemical Crosslinking in Combination with Mass Spectrometry, and much more. Other chapters cover Biochemical characterization of plant aromatic aminotransferases, Functional Analysis of Phosphoethanolamine N-methyltransferase (PMT) in Plants and Parasites, A structure-guided computational screening approach for predicting plant enzyme-metabolite interactions, Plant metacaspase: an example of microcrystal structure determination and analysis, Biocatalytic system for comparative assessment of functional association of cytochrome P450 monooxygenases with their redox partners, Dirigent Protein Family Function and Structure, and more. Provides the authority and expertise of leading contributors from an international board of authors Presents the latest release in Methods in Enzymology series Includes the latest information on Biochemical pathways and environmental responses in plants
Download or read book Liquid Chromatography written by Salvatore Fanali and published by Elsevier. This book was released on 2023-04-20 with total page 886 pages. Available in PDF, EPUB and Kindle. Book excerpt: Liquid Chromatography: Fundamentals and Instrumentation, Third Edition offers a single source of authoritative information on all aspects of the practice of modern liquid chromatography. The book gives those working in academia and industry the opportunity to learn, refresh, and deepen their understanding of the field by covering basic and advanced theoretical concepts, recognition mechanisms, conventional and advanced instrumentation, method development, data analysis, and more. This third edition addresses new developments in the field with updated chapters from expert researchers. The book is a valuable reference for research scientists, teachers, university students, industry professionals in research and development, and quality control managers. Emphasizes the integration of chromatographic methods and sample preparation Provides important data related to complex matrices, sample preparation, and data handling Gives background information to facilitate the choice of LC sub-technique and experimental conditions, mobile and stationary phases, detectors, data processing, and more Offers comprehensive updates to all chapters Includes new chapters on chiral recognition, co-solvents and mobile phase additives, physicochemical measurements, and identification and quantitation in mass spectrometry
Download or read book Validation in Thermal Analysis written by Markus Schubnell and published by Carl Hanser Verlag GmbH Co KG. This book was released on 2022-08-08 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation of equipment, processes and methods is a basic requirement that nowadays has to be met in most industries. This handbook deals with the validation of computerized systems in general as well as with analytical method validation. The many detailed practical examples focus on thermal analysis of materials, such as plastics and rubber. The handbook is intended for newcomers interested in the theoretical and regulatory aspects of validation and for thermal analysis practitioners who have to validate their equipment and methods. Contents: Part 1: Validation of Computerized Systems Recent Changes in Regulations and Regulatory Guidance Instrument Qualification, Computerized System Validation and Method Validation Regulatory Requirements for Computerized System Validation Computerized System Validation Writing the User Requirements Specification (URS) Auditing the System Supplier Installation Qualification and Operational Qualification (IQ and OQ) Performance Qualification (PQ) or End User Testing Part 2: Method Validation Measurement Errors and Uncertainty of Measurement Validation of Analytical Procedures and Methods Interlaboratory Studies in Thermal Analysis Method Development Through to SOP Practical Examples Appendix 1: 21 CFR Part 11 and EU GMP Annex 11 Appendix 2: Basic Statistics Appendix 3: Standard Test Methods for Thermal Analysis
Download or read book Calibration and Validation of Analytical Methods written by Mark Stauffer and published by BoD – Books on Demand. This book was released on 2018-04-25 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
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 Handbook of Analytical Validation written by Michael E Swartz and published by CRC Press. This book was released on 2014-09-19 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, it contains practical, up-to-date guidelines for analytical method validation. It also covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment. Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as the biotech industry.
