hardikkumar patel analytical method development and validation

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Herman Lam Practical Approaches to Method Validation and Essential Instrument Qualification

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.

9148.72 рублей

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Joachim Ermer Method Validation in Pharmaceutical Analysis. A Guide to Best Practice

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

15897.66 рублей

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Madden Timothy L. Analytical Methods for Therapeutic Drug Monitoring and Toxicology

This book is a compilation of summarized analytical methods designed to serve the needs of pharmacologists, toxicologists, and other allied health professionals involved the development, use, or monitoring of pharmaceuticals. The summaries are structured monographs on 511 different drug entities detailing 964 different analytical methods, providing the reader with a thorough description of method validation. These analytical methods include not only high performance liquid chromatography (HPLC), but also gas chromatography (GC), immunoassay, electrophoresis, ultra performance liquid chromatography (UPLC) coupled with UV (UPLC-UV) detection and mass spectrometry (UPLC-MS/MS). With more detailed and complete summaries than sketchy and abbreviated formats used in the other books, this book provides a thorough description of method validation and results, as well as the operating parameters.

14157.98 рублей

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Findlay John W. Ligand-Binding Assays. Development, Validation, and Implementation in the Drug Development Arena

A consolidated and comprehensive reference on ligand-binding assays Ligand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field. Ligand-Binding Assays covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include: A general discussion of challenges and proven approaches in the development of ligand-binding assays More detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline A concise, but detailed, discussion of validation of ligand-binding assays for macromolecules A practical approach to «fit-for-purpose» validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies Written by a team of world-recognized authorities in the field, Ligand-Binding Assays provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.

10890.75 рублей

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David Elder ICH Quality Guidelines. An Implementation Guide

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

26245.91 рублей

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Yiyang Dong Aptamers for Analytical Applications. Affinity Acquisition and Method Design

An essential guide that puts the focus on method developments and applications in aptamers In recent years, aptamer-based systems have been developed for a wide-range of analytical and medical applications. Aptamers for Analytical Applications offers an introduction to the topic, outlines the common protocols for aptamer synthesis, as well as providing information on the different optimization strategies that can obtain higher affinities to target molecules. The contributors?noted experts on the topic?provide an in-depth review of the characterization of aptamer-target molecule interaction and immobilization strategies and discuss the developments of methods for all the relevant applications. The book outlines different schemes to efficiently immobilize aptamers on substrates as well as summarizing the characterization methods for aptamer-ligand complexes. In addition, aptamer-based colorimetric, enzyme-linked, fluorescent, electrochemical, lateral flow and non-labeling analytical methods are presented. The book also reflects state-of-the-art and emerging applications of aptamer-based methods. This important resource: -Provides a guide to aptamers which provide highly specific and sensitive molecular recognition, with affinities in the range of antibodies and are much cheaper to produce -Offers a discussion of the analytical method developments and improvements with established systems and beyond -Offers a comprehensive guide to all the relevant application areas -Presents an authoritative book from contributors who are noted experts in the field Written for analytical chemists, biochemists, analytical researchers, Aptamers for Analytical Applications is a comprehensive book that adopts a methodological point of view to the important aspects of aptamer generation and modification with a strong emphasis on method developments for relevant applications.

14388.76 рублей

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Behnam Davani Pharmaceutical Analysis for Small Molecules

A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

9373.54 рублей

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Jian Wang Chemical Analysis of Antibiotic Residues in Food

An insightful exploration of the key aspects concerning the chemical analysis of antibiotic residues in food The presence of excess residues from frequent antibiotic use in animals is not only illegal, but can pose serious health risks by contaminating products for human consumption such as meat and milk. Chemical Analysis of Antibiotic Residues in Food is a single-source reference for readers interested in the development of analytical methods for analyzing antibiotic residues in food. It covers themes that include quality assurance and quality control, antibiotic chemical properties, pharmacokinetics, metabolism, distribution, food safety regulations, and chemical analysis. In addition, the material presented includes background information valuable for understanding the choice of marker residue and target animal tissue to use for regulatory analysis. This comprehensive reference: Includes topics on general issues related to screening and confirmatory methods Presents updated information on food safety regulation based on routine screening and confirmatory methods, especially LC-MS Provides general guidance for method development, validation, and estimation of measurement uncertainty Chemical Analysis of Antibiotic Residues in Food is written and organized with a balance between practical use and theory to provide laboratories with a solid and reliable reference on antibiotic residue analysis. Thorough coverage elicits the latest scientific findings to assist the ongoing efforts toward refining analytical methods for producing safe foods of animal origin.

9523.66 рублей

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Michael Rychlik Fortified Foods with Vitamins. Analytical Concepts to Assure Better and Safer Products

Unique in its review of modern analytical approaches to vitamin fortification, this book emphasizes fast, sensitive, and accurate methods, along with assays enabling the detection of various isomers and multiple vitamins. The expert contributors describe the concepts as well as analytical and assay methods to study fortification, along with applications to create better and safer foods. Taking into considerations regulatory matters, they include data on sampling and extraction methods, and discuss the various pros and cons of each. As a result, readers are able to determine, which type of analytical method is best suited for added vitamins. A practical guide for food chemists and technologists, as well as analytical laboratories and biochemists.

2174.26 рублей

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Harald Seitz Biomarker Validation. Technological, Clinical and Commercial Aspects

Built on a decade of experience with novel molecular diagnostics, this practice-oriented guide shows how to cope with validation issues during all stages of biomarker development, from the first clinical studies to the eventual commercialization of a new diagnostic test.

12373.78 рублей

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Xiaojun Yang Urban Remote Sensing. Monitoring, Synthesis and Modeling in the Urban Environment

Urban Remote Sensing is designed for upper level undergraduates, graduates, researchers and practitioners, and has a clear focus on the development of remote sensing technology for monitoring, synthesis and modeling in the urban environment. It covers four major areas: the use of high-resolution satellite imagery or alternative sources of image date (such as high-resolution SAR and LIDAR) for urban feature extraction; the development of improved image processing algorithms and techniques for deriving accurate and consistent information on urban attributes from remote sensor data; the development of analytical techniques and methods for deriving indicators of socioeconomic and environmental conditions that prevail within urban landscape; and the development of remote sensing and spatial analytical techniques for urban growth simulation and predictive modeling.

9895.04 рублей

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Xiaojun Yang Urban Remote Sensing. Monitoring, Synthesis and Modeling in the Urban Environment

Urban Remote Sensing is designed for upper level undergraduates, graduates, researchers and practitioners, and has a clear focus on the development of remote sensing technology for monitoring, synthesis and modeling in the urban environment. It covers four major areas: the use of high-resolution satellite imagery or alternative sources of image date (such as high-resolution SAR and LIDAR) for urban feature extraction; the development of improved image processing algorithms and techniques for deriving accurate and consistent information on urban attributes from remote sensor data; the development of analytical techniques and methods for deriving indicators of socioeconomic and environmental conditions that prevail within urban landscape; and the development of remote sensing and spatial analytical techniques for urban growth simulation and predictive modeling.

10264.53 рублей

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Mike Lee S. Protein Analysis using Mass Spectrometry. Accelerating Protein Biotherapeutics from Lab to Patient

Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives Brings together the most current advances in the mass spectrometry technology and related method in protein analysis

13122.95 рублей

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Tapan Das K. Biophysical Methods for Biotherapeutics. Discovery and Development Applications

With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

9673.78 рублей

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Miguel de la Guardia Handbook of Green Analytical Chemistry

The emerging field of green analytical chemistry is concerned with the development of analytical procedures that minimize consumption of hazardous reagents and solvents, and maximize safety for operators and the environment. In recent years there have been significant developments in methodological and technological tools to prevent and reduce the deleterious effects of analytical activities; key strategies include recycling, replacement, reduction and detoxification of reagents and solvents. The Handbook of Green Analytical Chemistry provides a comprehensive overview of the present state and recent developments in green chemical analysis. A series of detailed chapters, written by international specialists in the field, discuss the fundamental principles of green analytical chemistry and present a catalogue of tools for developing environmentally friendly analytical techniques. Topics covered include: Concepts: Fundamental principles, education, laboratory experiments and publication in green analytical chemistry. The Analytical Process: Green sampling techniques and sample preparation, direct analysis of samples, green methods for capillary electrophoresis, chromatography, atomic spectroscopy, solid phase molecular spectroscopy, derivative molecular spectroscopy and electroanalytical methods. Strategies: Energy saving, automation, miniaturization and photocatalytic treatment of laboratory wastes. Fields of Application: Green bioanalytical chemistry, biodiagnostics, environmental analysis and industrial analysis. This advanced handbook is a practical resource for experienced analytical chemists who are interested in implementing green approaches in their work.

15324.84 рублей

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Litwin Virginia Flow Cytometry in Drug Discovery and Development

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

10812.96 рублей

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Sean Ekins Predictive Approaches in Drug Discovery and Development. Biomarkers and In Vitro / In Vivo Correlations

Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

11248.25 рублей

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Herbert W. Seliger Second Language Research Methods

Based on a set of four research parameters, this book discusses the development of research questions and hypotheses, naturalistic and experimental research, data collection, and validation of research instruments. Each chapter includes examples and activities.

2656.08 рублей

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A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

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