HPLC in the Pharmaceutical Industry


Author: Godwin W. Fong
Publisher: CRC Press
ISBN: 9780824784997
Category: Science
Page: 326
View: 6551

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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

HPLC for Pharmaceutical Scientists


Author: Yuri V. Kazakevich,Rosario LoBrutto
Publisher: John Wiley & Sons
ISBN: 0470087943
Category: Science
Page: 1080
View: 2937

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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.

Handbook of Pharmaceutical Analysis by HPLC


Author: Satinder Ahuja,Michael Dong
Publisher: Elsevier
ISBN: 9780080455181
Category: Medical
Page: 600
View: 1826

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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

Pharmaceutical Analysis for Small Molecules


Author: Behnam Davani
Publisher: John Wiley & Sons
ISBN: 1119121116
Category: Medical
Page: 256
View: 1898

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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.

High-Throughput Analysis in the Pharmaceutical Industry


Author: Perry G. Wang
Publisher: CRC Press
ISBN: 9781420059540
Category: Medical
Page: 432
View: 9325

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The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corresponding revolutionary improvement to the conventional methodology must happen.

A Handbook of Bioanalysis and Drug Metabolism


Author: Gary Evans
Publisher: CRC Press
ISBN: 9780203642535
Category: Medical
Page: 408
View: 6156

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Recent years have seen a greater industrial emphasis in undergraduate and postgraduate courses in the pharmaceutical and chemical sciences. However, textbooks have been slow to adapt, leaving the field without a text/reference that is both instructional and practical in the industrial setting – until now. A Handbook of Bioanalysis and Drug Metabolismis a stimulating new text that examines the techniques, methodology, and theory of bioanalysis, pharmacokinetics, and metabolism from the perspective of scientists with extensive professional experience in drug discovery and development. These three areas of research help drug developers to optimize the active component within potential drugs thereby increasing their effectiveness, and to provide safety and efficacy information required by regulators when granting a drug license. Professionals with extensive experience in drug discovery and development as well as specialized knowledge of the individual topics contributed to each chapter to create a current and well-credentialed text. It covers topics such as high performance liquid chromatography, protein binding, pharmacokinetics and drug–drug interactions. The unique industrial perspective helps to reinforce theory and develop valuable analytical and interpreting skills. This text is an invaluable guide to students in courses such as pharmaceutical science, pharmacology, chemistry, physiology and toxicology, as well as professionals in the biotechnology industry.

HPLC Method Development for Pharmaceuticals


Author: Satinder Ahuja,Henrik Rasmussen
Publisher: Elsevier
ISBN: 0080554199
Category: Medical
Page: 532
View: 9059

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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

Job$ in the Drug Indu$try

A Career Guide for Chemists
Author: Richard J. Friary
Publisher: Elsevier
ISBN: 9780080509624
Category: Science
Page: 364
View: 3754

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This book is intended to help newly graduated chemists, particularly organic chemists, at all levels from bachelors to post-doctorates, find careers in the North American pharmaceutical industry. It will serve as a practical, detailed guiedbook for job seekers as well a reference work for faculty advisers, research supervisors, development officers, employment agents, and personnel managers in the industry. The book gathers in a single volume the fundamentals of getting an industrial job as a medicinal or process chemist, and covers all aspects of a chemist's job--scientific, financial, and managerial--within a pharmaceutical/biotechnology company. Other scientists looking for jobs as analytical or physical chemists and even biochemists and biologists will find the book useful. The valuable appendix is a unique compendium of 365 commercial, governmental, or non-profit institutions that comprise the North American pharmaceutical industry. Learn How To: Discover the 12 permanent, big-pharma jobs for B.S. chemists Use the 500+ company index to locate potential employers Track pharma openings with 190+ corporate and chemist-specific job banks Add industry veterans to your employment network Find the 50+ companies offering paid summer internships to students Include the one resume item that wins interviews for B.S. and M.S. chemists Express a knowledgeable preference for drug discovery or development Research over 360 drug companies through their Web sites Discover the 70+ firms offering stock purchase plans or stock options3⁄4and which two represent big pharma Find out your salary offer in time to negotiate your wages

On-line LC-NMR and Related Techniques


Author: Klaus Albert
Publisher: John Wiley & Sons
ISBN: 0470854812
Category: Science
Page: 306
View: 1625

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This book gives a comprehensive overview of the basis and the current applications of LC-NMR and related techniques. It deals with the practical aspects of the hardware and software set-up for a successful performance of on-line coupling experiments. It covers the solution of real-word problems from the fields of biomedical, pharmaceutical and environmental studies as well as the analysis of natural products and polymeric compounds. Thus guidelines for an efficient application of the powerful hyphenated technique LC-NMR in combination with LC-MS are presented. Besides LC-NMR, important techniques such as the on-line coupling of gel permeation chromatography and supercritical fluid chromatography, together with 1H NMR spectroscopy, are described in detail. Fascinating further aspects, such as the application of capillary separation techniques either in the single or parallel detection mode, together with the possibilities of direct 13C monitoring of chromatographic events, are also discussed. Key features include: * Up-to-date information on the theoretical and experimental methodology * Coverage of applications in biomedical, pharmaceutical and natural product analysis, as well as environmental polymer and related hyphenated techniques * Information appropriate for researchers in organic, pharmaceutical and medical chemistry Overall, this book is a requirement for all researchers and staff members dealing with structure elucidation problems in separation science.

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition


Author: N.A
Publisher: ScholarlyEditions
ISBN: 1464963444
Category: Medical
Page: 4229
View: 4956

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Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Bioanalytical Separations


Author: N.A
Publisher: Elsevier
ISBN: 9780080527864
Category: Science
Page: 442
View: 8245

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Bioanalytical Separations is volume 4 of the multi-volume series, Handbook of Analytical Separations, providing reviews of analytical separation methods and techniques used for the determination of analytes across a whole range of applications. The theme for this volume is bioanalysis, in this case specifically meaning the analysis of drugs and their metabolites in biological fluids. - Discusses new developments in instrumentation and methods of analyzing drugs and their metabolites in biological fluids - Provides guidance to the different methods, their relative value to the user, and the advantages and pitfalls of their use - Future trends are identified, in terms of the potential impact of new technologies

Beyond the Molecular Frontier

Challenges for Chemistry and Chemical Engineering
Author: National Research Council,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Committee on Challenges for the Chemical Sciences in the 21st Century
Publisher: National Academies Press
ISBN: 0309084776
Category: Science
Page: 238
View: 4957

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Chemistry and chemical engineering have changed significantly in the last decade. They have broadened their scopeâ€"into biology, nanotechnology, materials science, computation, and advanced methods of process systems engineering and controlâ€"so much that the programs in most chemistry and chemical engineering departments now barely resemble the classical notion of chemistry. Beyond the Molecular Frontier brings together research, discovery, and invention across the entire spectrum of the chemical sciencesâ€"from fundamental, molecular-level chemistry to large-scale chemical processing technology. This reflects the way the field has evolved, the synergy at universities between research and education in chemistry and chemical engineering, and the way chemists and chemical engineers work together in industry. The astonishing developments in science and engineering during the 20th century have made it possible to dream of new goals that might previously have been considered unthinkable. This book identifies the key opportunities and challenges for the chemical sciences, from basic research to societal needs and from terrorism defense to environmental protection, and it looks at the ways in which chemists and chemical engineers can work together to contribute to an improved future.

Chemical Engineering in the Pharmaceutical Industry

R&D to Manufacturing
Author: David J. am Ende
Publisher: John Wiley & Sons
ISBN: 1118088107
Category: Technology & Engineering
Page: 904
View: 763

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This book deals with various unique elements in the drugdevelopment process within chemical engineering science andpharmaceutical R&D. The book is intended to be used as aprofessional reference and potentially as a text book reference inpharmaceutical engineering and pharmaceutical sciences. Many of theexperimental methods related to pharmaceutical process developmentare learned on the job. This book is intended to provide many ofthose important concepts that R&D Engineers and manufacturingEngineers should know and be familiar if they are going to besuccessful in the Pharmaceutical Industry. These include basicanalytics for quantitation of reaction components– oftenskipped in ChE Reaction Engineering and kinetics books. In additionChemical Engineering in the Pharmaceutical Industryintroduces contemporary methods of data analysis for kineticmodeling and extends these concepts into Quality by Designstrategies for regulatory filings. For the current professionals,in-silico process modeling tools that streamlineexperimental screening approaches is also new and presented here.Continuous flow processing, although mainstream for ChE, is uniquein this context given the range of scales and the complex economicsassociated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts.These parts will address the fundamentals of analytical techniquesfor engineers, thermodynamic modeling, and finally provides anappendix with common engineering tools and examples of theirapplications.

Preparative Chromatography Techniques

Applications in Natural Product Isolation
Author: K. Hostettmann,Andrew MARSTON,Maryse Hostettmann
Publisher: Springer Science & Business Media
ISBN: 9783540624592
Category: Science
Page: 247
View: 7988

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Over the past few years, increasing attention has been paid to the search for bioactive compounds from natural sources. The success of plant-derived products such as paclitaxel (Taxol) in tumor therapy or artemisinin in the treatment of malaria has provided the impetus for the introduction of numerous research programmes, especially in Industry. A great deal of effort is being expended in the generation of novel lead molecules of vegetable, marine and microbial origin by the use of high throughput screening protocols. When interesting hits are found, it is essen tial to have methods available for the rapid isolation of target compounds. For this reason, both industry and academia need efficient preparative chromatographic separation techniques and experience in their application. Purified natural products are required for complete spectro scopic identification and full characterization of new compo unds, for biological testing and for the supply of pharmaceuti cals, standards, and starting materials for synthetic work. Obtaining pure products from an extract can be a very long, te dious and expensive undertaking, involving many steps. Sometimes only minute amounts of the desired compounds are at hand and these entities may be labile. Thus it is an advantage to have access to as many different methods as possible in order to aid the isolation process. Although a certain amount of trial and error may be involved, nowadays there is the possibility of devising suitable rapid separation schemes by a judicious choice of the different techniques available.

Chiral Separation Methods for Pharmaceutical and Biotechnological Products


Author: Satinder Ahuja
Publisher: John Wiley & Sons
ISBN: 9781118097755
Category: Science
Page: 400
View: 9360

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Discusses chiral separations and offers guidance for selectingthe optimum method for desired results Chiral separations represent the most intriguing and, by somemeasures, most difficultseparations of chemical compounds. Thisbook provides researchers and students an under-standing of chiralseparations and offers a convenient route to selecting the bestseparation method, saving considerable time and cost in productdevelopment. Considering chiral separations in the biotechnological andpharmaceutical industries, as well as for food applications, Dr.Ahuja provides insights into a broad range of topics. Opening witha broad overview of chiral separations, regulatory considerationsin drug product development, and basic issues in methoddevelopment, the book: Covers a variety of modern methods such as gas chromatography,high performance liquid chromatography, supercritical fluidchromatography, and capillary electrophoresis Deals with the impact of chirality on the biological activity ofsmall and large molecules Provides detailed information on useful chiral stationary phases(CSPs) for HPLC Includes handy information on selection of an appropriate CSP,including mechanistic studies Offers strategies for fast method development with HPLC, SFC,and CE Discusses preparatory methods utilized in the pharmaceuticalindustry With in-depth discussions of the current state of the field aswell as suggestions to assist future developments, ChiralSeparation Methods for Pharmaceutical and BiotechnologicalProducts is an essential text for laboratory investigators,managers, and regulators who are involved in chiral separations inthe pharmaceutical industry, as well as students preparing forcareers in these fields.

Chromatographic Analysis of Pharmaceuticals, Second Edition


Author: John A. Adamovics
Publisher: CRC Press
ISBN: 9780824797768
Category: Science
Page: 542
View: 4516

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Updated and revised throughout. Second Edition explores the chromatographic methods used for the measurement of drugs, impurities, and excipients in pharmaceutical preparations--such as tablets, ointments, and injectables. Contains a 148-page table listing the chromatographic data of over 1300 drugs and related substances--including sample matrix analyzed, sample handling procedures, column packings, mobile phase, mode of detection, and more.

LC-NMR

Expanding the Limits of Structure Elucidation
Author: Nina C. Gonnella
Publisher: CRC Press
ISBN: 1439875073
Category: Science
Page: 301
View: 2648

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The isolation and structural characterization of substances present at very low concentrations, as is necessary to satisfy regulatory requirements for pharmaceutical drug degradants and impurities, can present scientific challenges. The coupling of HPLC with NMR spectroscopy has been at the forefront of cutting-edge technologies to address these issues. LC-NMR: Expanding the Limits of Structure Elucidation presents a comprehensive overview of key concepts in HPLC and NMR that are required to achieve definitive structure elucidation with very low levels of analytes. Because skill sets from both of these highly established disciplines are involved in LC-NMR, the author provides introductory background to facilitate readers’ proficiency in both areas, including an entire chapter on NMR theory. This book provides guidance in setting up LC-NMR systems, discussion of LC methods that are compatible with NMR, and an update on recent hardware and software advances for system performance, such as improvements in magnet design, probe technology, and solvent suppression techniques that enable unprecedented mass sensitivity in NMR. It also describes numerous NMR collection strategies, including continuous flow, stop flow, solid phase extraction (SPE), loop collection, and capillary electrophoresis. In addition, the author presents an overview of NMR experiments and techniques used in structure elucidation. The text focuses on current developments in chromatographic-NMR integration, with particular emphasis on utility in the pharmaceutical industry. Applications include trace analysis, analysis of mixtures, and detection of degradation products, impurities, metabolites, peptides, and more. The text discusses novel uses and emerging technologies that challenge detection limits as well future directions for this important technique. This book is a practical primary resource for NMR structure determination—including theory and application—that guides the reader through the steps required for isolation and NMR structure elucidation on the micro scale.

Nuclear Imaging in Drug Discovery, Development, and Approval


Author: BURNS
Publisher: Springer Science & Business Media
ISBN: 1468468081
Category: Juvenile Nonfiction
Page: 344
View: 4007

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It is the purpose and business of the pharmaceutical industry to dis cover, develop, and make available drugs for the care of the sick. The purpose of universities and national laboratories is to provide people and scientific knowledge that can help in the process. This book presents the combined efforts of scientists from the drug in dustry, academic laboratories and national laboratories to describe advances in radiotracer technology in studies on experimental ani mals and living human beings. The authors believe that the technol ogy is now ready for widespread application in the pharmaceutical industry. The goal of this book is to help bring this about. The field of Nuclear Medicine is based on the concept that, if treatment of disease is chemical, the patient's diagnosis should be chemical. Anatomy and histopathology have been the principle ba sis for making a diagnosis. Histopathologic data suffer from being descriptive, subjective, not quantifiable, and based on the study of dead tissue. The era of histopathology as the dominant concept in medical practice is coming to an end. Histopathologic findings are often heterogeneous and a single biopsy will at times not reveal the true nature of the disease, such as the grading of malignancy. Far greater accuracy of staging of disease and in the planning of treat ment is possible through chemistry, as well as by making possible a more suitable selection of a histological biopsy site.