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Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher :Unknown
  • Release Date :2001
  • Total pages :566
  • ISBN : 0120455552
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Summary : This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher :Unknown
  • Release Date :2010-11-11
  • Total pages :598
  • ISBN : 0123759811
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Summary : Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher :Unknown
  • Release Date :2001-08-02
  • Total pages :566
  • ISBN : 0080488927
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Summary : This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher :Unknown
  • Release Date :2010-09-29
  • Total pages :582
  • ISBN : 0123756804
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Summary : Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Pharmaceutical Analysis

Handbook of Pharmaceutical Analysis
  • Author : Lena Ohannesian,Anthony Streeter
  • Publisher :Unknown
  • Release Date :2001-11-09
  • Total pages :608
  • ISBN : 0824741943
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Summary : Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher :Unknown
  • Release Date :2018-08-31
  • Total pages :890
  • ISBN : 9780323481038
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Summary : Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Pharmaceutical Drug Analysis

Pharmaceutical Drug Analysis
  • Author : Ashutosh Kar
  • Publisher :Unknown
  • Release Date :2005-12
  • Total pages :554
  • ISBN : 8122415822
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Summary : About the Book: During the past two decades, there have been magnificent and significant advances in both analytical instrumentation and computerized data handling devices across the globe. In this specific context the remarkable proliferation of windows

Handbook on Miniaturization in Analytical Chemistry

Handbook on Miniaturization in Analytical Chemistry
  • Author : Chaudhery Mustansar Hussain
  • Publisher :Unknown
  • Release Date :2020-07-25
  • Total pages :364
  • ISBN : 9780128225530
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Summary : Handbook on Miniaturization in Analytical Chemistry: Application of Nanotechnology provides a source of authoritative fundamentals, interdisciplinary knowledge and primary literature for researchers who want to fully understand how nano-technologies work. Covering all stages of analysis, from sample preparation to separation and detection, the book discusses the design and manufacturing technology of miniaturization and includes an entire section on safety risks, ethical, legal and social issues (ELSI), the economics of nanotechnologies, and a discussion on sustainability with respect to nano- and lab-on-chip technologies. This guide for students and researchers working on applications of nanotechnology in modern systems for analysis gives readers everything they need to know to bring their current practices up-to-date. Details the impacts of miniaturization and nanotechnology Includes coverage of the current challenges for scaling up nano-miniaturization design and manufacturing technology for analysis Provides the latest reference materials, including websites of interest and details on the latest research in every chapter

Analysis of Pharmaceuticals by Capillary Electrophoresis

Analysis of Pharmaceuticals by Capillary Electrophoresis
  • Author : Kevin D. Altria
  • Publisher :Unknown
  • Release Date :2013-04-17
  • Total pages :285
  • ISBN : 9783322850119
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Summary : Dieser erste Titel einer ganzen Serie von anwendungsbezogenen Handbüchern zur Kapillarelektrophorese beschäftigt sich mit der Analytik von pharmazeutischen Substanzen. Dabei werden verschiedene Techniken praxisnah erläutert. Jeder, der im Labor - ob wissenschaftlich oder praxisnah - mit der Analyse von oft chiralen Pharmazeutika konfrontiert ist, wird viele Hinweise und Tips für seine Arbeit finden.USP: Einzige Monographie zur Analyse von Pharmazeutika mit CE This book describes the current state of the art for the analysis of pharmaceuticals by capillary electrophoresis and contains several hundred references to specific applications and methods. The main purpose of the book is to present the application possibilities of CE an therefore tabulated application data are provided. Chapters of the book are devoted to providing details of individual application areas such as chiral analysis, determination of drug related impurities, determination of drug counter-ions, drug residue monitoring and main component assay. An introductory chapter provides theoretical background to CE an related techniques. A chapter is dedicated to capillary electrochromatography which highlights the importance this technique currently possesses. Successful regulatory acceptance of CE methods is also described. A comprehensive chapter covers method validation aspects. Other chapters include discrete areas such as the use of non-aqueous solvents, forensic applications of CE, the application of experimental designs, determination of drugs in biofluids, and the analysis of vitamins by CE.

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher :Unknown
  • Release Date :2021-01-09
  • Total pages :222
  • ISBN : 9780128203330
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Summary : 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

Handbook of Analysis of Oligonucleotides and Related Products

Handbook of Analysis of Oligonucleotides and Related Products
  • Author : Jose V. Bonilla,G. Susan Srivatsa
  • Publisher :Unknown
  • Release Date :2011-02-23
  • Total pages :511
  • ISBN : 9781439819937
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Summary : Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. The Handbook of Analysis of Oligonucleotides and Related Products is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. A strong collaboration among thirty leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use. Topics discussed include: Strategies for enzymatic or chemical degradation of chemically modified oligonucleotides toward mass spectrometric sequencing Purity analysis by chromatographic or electrophoretic methods, including RP-HPLC, AX-HPLC, HILIC, SEC, and CGE Characterization of sequence-related impurities in oligonucleotides by mass spectrometry and chromatography Structure elucidation by spectroscopic methods (IR, NMR, MS) as well as base composition and thermal melt analysis (Tm) Approaches for the accurate determination of molar extinction coefficient of oligonucleotides Accurate determination of assay values Assessment of the overall quality of oligonucleotides, including microbial analysis and determination of residual solvents and heavy metals Strategies for determining the chemical stability of oligonucleotides The use of hybridization techniques for supporting pharmacokinetics and drug metabolism studies in preclinical and clinical development Guidance for the presentation of relevant analytical information towards meeting current regulatory expectations for oligonucleotide therapeutics This resource provides a practical guide for applying state-of-the-art analytical techniques in research, development, and manufacturing settings.

Handbook of Thermal Analysis and Calorimetry

Handbook of Thermal Analysis and Calorimetry
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2018-03-12
  • Total pages :860
  • ISBN : 9780444640635
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Summary : Handbook of Thermal Analysis and Calorimetry: Recent Advances, Techniques and Applications, Volume Six, Second Edition, presents the latest in a series that has been well received by the thermal analysis and calorimetry community. This volume covers recent advances in techniques and applications that complement the earlier volumes. There has been tremendous progress in the field in recent years, and this book puts together the most high-impact topics selected for their popularity by new editors Sergey Vyazovkin, Nobuyoshi Koga and Christoph Schick—all editors of Thermochimica Acta. Among the important new techniques covered are biomass conversion; sustainable polymers; polymer nanocompsoties; nonmetallic glasses; phase change materials; propellants and explosives; applications to pharmaceuticals; processes in ceramics, metals, and alloys; ionic liquids; fast-scanning calorimetry, and more. Features 19 all-new chapters to bring readers up to date on the current status of the field Provides a broad overview of recent progress in the most popular techniques and applications Includes chapters authored by a recognized leader in each field and compiled by a new team of editors, each with at least 20 years of experience in the field of thermal analysis and calorimetry Enables applications across a wide range of modern materials, including polymers, metals, alloys, ceramics, energetics and pharmaceutics Overviews the current status of the field and summarizes recent progress in the most popular techniques and applications

Handbook of Analytical Therapeutic Drug Monitoring and Toxicology (1996)

Handbook of Analytical Therapeutic Drug Monitoring and Toxicology (1996)
  • Author : Steven H.Y. Wong,Irving Sunshine
  • Publisher :Unknown
  • Release Date :2017-11-22
  • Total pages :366
  • ISBN : 9781351364270
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Summary : Adapting modern advances in analytical techniques to daily laboratory practices challenges many toxicologists, clinical laboratories, and pharmaceutical scientists. The Handbook of Analytical Therapeutic Drug Monitoring and Toxicology helps you keep abreast of the innovative changes that can make your laboratory - and the studies undertaken in it - a success. This volume simplifies your search for appropriate techniques, describes recent contributions from leading investigators, and provides valuable evaluations and advice.

Pharmaceutical Analysis E-Book

Pharmaceutical Analysis E-Book
  • Author : David G. Watson
  • Publisher :Unknown
  • Release Date :2015-12-24
  • Total pages :480
  • ISBN : 9780702069888
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Summary : Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of chemical, physical and microbiological analyses. It is reckoned that over £10 billion is spent annually in the UK alone on pharmaceutical analysis, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. This is the key textbook in pharmaceutical analysis, now revised and updated for its fourth edition. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes New chapter on Biotech products. New chapter on electrochemical methods in diagnostics. Greatly extended chapter on molecular emission spectroscopy to accommodate developments and innovations in the area. Now on StudentConsult

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
  • Author : Satinder Ahuja,Karen Mills Alsante
  • Publisher :Unknown
  • Release Date :2003-06-26
  • Total pages :430
  • ISBN : 9780080507767
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Summary : The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Pharmaceutical Analysis

Pharmaceutical Analysis
  • Author : James W. Munson
  • Publisher :Unknown
  • Release Date :1984-11-30
  • Total pages :496
  • ISBN : 0824772512
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Summary :

Introduction to Pharmaceutical Analytical Chemistry

Introduction to Pharmaceutical Analytical Chemistry
  • Author : Stig Pedersen-Bjergaard,Bente Gammelgaard,Trine G. Halvorsen
  • Publisher :Unknown
  • Release Date :2019-02-11
  • Total pages :544
  • ISBN : 9781119362753
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Summary : The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.

The Oxford Handbook of Applied Bayesian Analysis

The Oxford Handbook of Applied Bayesian Analysis
  • Author : Anthony O' Hagan,Mike West
  • Publisher :Unknown
  • Release Date :2010-03-18
  • Total pages :928
  • ISBN : 9780191582820
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Summary : Bayesian analysis has developed rapidly in applications in the last two decades and research in Bayesian methods remains dynamic and fast-growing. Dramatic advances in modelling concepts and computational technologies now enable routine application of Bayesian analysis using increasingly realistic stochastic models, and this drives the adoption of Bayesian approaches in many areas of science, technology, commerce, and industry. This Handbook explores contemporary Bayesian analysis across a variety of application areas. Chapters written by leading exponents of applied Bayesian analysis showcase the scientific ease and natural application of Bayesian modelling, and present solutions to real, engaging, societally important and demanding problems. The chapters are grouped into five general areas: Biomedical & Health Sciences; Industry, Economics & Finance; Environment & Ecology; Policy, Political & Social Sciences; and Natural & Engineering Sciences, and Appendix material in each touches on key concepts, models, and techniques of the chapter that are also of broader pedagogic and applied interest.

Handbook of Solubility Data for Pharmaceuticals

Handbook of Solubility Data for Pharmaceuticals
  • Author : Abolghasem Jouyban
  • Publisher :Unknown
  • Release Date :2009-08-26
  • Total pages :552
  • ISBN : 1439804885
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Summary : Aqueous solubility is one of the major challenges in the early stages of drug discovery. One of the most common and effective methods for enhancing solubility is the addition of an organic solvent to the aqueous solution. Along with an introduction to cosolvency models, the Handbook of Solubility Data for Pharmaceuticals provides an extensive database of solubility for pharmaceuticals in mono solvents and binary solvents. Aqueous solubility data can be found in the Handbook of Aqueous Solubility Data by Samuel Yalkowsky and Yan He. Visit www.crcpress.com for more information. In addition to the experimental efforts to measure the solubility of drugs in mono and mixed solvents, this book discusses the advantages and limitations of a number of mathematical models used to predict the solubility in mono or mixed solvent systems. It covers the pharmaceutical cosolvents and other organic solvents that are used in syntheses, separations, and other pharmaceutical processes. The solutes featured include the available data for official drugs, drug candidates, precursors of drugs, metabolites, and degradation products of pharmaceuticals. The author also presents the solubilities of amino acids since they play an important role in peptide drug properties. Collecting drug solubilities in various cosolvents, this time-saving handbook includes the mixtures and model constants needed to predict undetermined solubilities. It describes mathematical models that enable data to be derived and provides estimates on how drugs are likely to behave in a given cosolvent. A software program and associated user manual are available on the author’s website.

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC
  • Author : Satinder Ahuja,Michael Dong
  • Publisher :Unknown
  • Release Date :2005-02-09
  • Total pages :600
  • ISBN : 0080455182
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Summary : High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling

Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing
  • Author : Sarfaraz K. Niazi
  • Publisher :Unknown
  • Release Date :2007-08-22
  • Total pages :550
  • ISBN : 0849383595
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Summary : As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made