HPLC Methods for Clinical Pharmaceutical Analysis PDF Download
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Author: Hermann Mascher
Publisher: John Wiley & Sons
ISBN: 3527331298
Category : Science
Languages : en
Pages : 0
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Book Description
Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind
Author: Hermann Mascher
Publisher: John Wiley & Sons
ISBN: 3527331298
Category : Science
Languages : en
Pages : 0
Get Book Here
Book Description
Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author`s own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind
Author: George Lunn
Publisher: Wiley-Interscience
ISBN: 9780471332961
Category : Science
Languages : en
Pages : 0
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Book Description
The most commonly used method for analyzing substances, and the first method most researchers turn to, is high performance liquid chromatography (HPLC). Following up on a best-seller, volumes 2-4 continue to provide an easily-accessible collection of procedures for analyzing pharmaceuticals using HPLC.
Author: George Lunn
Publisher: John Wiley & Sons
ISBN: 0471711675
Category : Science
Languages : en
Pages : 743
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Book Description
An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080554199
Category : Medical
Languages : en
Pages : 533
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Book Description
High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. - Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory - Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) - Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase
Author: Yuri V. Kazakevich
Publisher: John Wiley & Sons
ISBN: 0470087943
Category : Science
Languages : en
Pages : 1136
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Book Description
HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Author: Godwin W. Fong
Publisher: CRC Press
ISBN: 9780824784997
Category : Science
Languages : en
Pages : 332
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Book Description
A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an
Author: Michael W. Dong
Publisher: John Wiley & Sons
ISBN: 111929360X
Category : Science
Languages : en
Pages : 285
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Book Description
A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.
Author: Oona McPolin
Publisher: Lulu.com
ISBN: 0956152813
Category : Medical
Languages : en
Pages : 154
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Book Description
This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Author: David G. Watson
Publisher: Elsevier Health Sciences
ISBN: 0702069884
Category : Medical
Languages : en
Pages : 598
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Book Description
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 electrochemical biosensors. New chapter on the quality control of biotechnologically produced drugs. Extended chapter on molecular emission spectroscopy. Now comes with an e-book on StudentConsult. Self-assessment is interactive in the accompanying online e-book. 65 online animations show concepts such as ionization partitioning of drug molecules etc. ~
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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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.
