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Author: Atta-ur- Rahman
Publisher: Bentham Science Publishers
ISBN: 1681085747
Category : Science
Languages : en
Pages : 466
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Book Description
Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents information about a selection of analytical techniques. Readers will find information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. Novel Developments in Pharmaceutical and Biomedical Analysis is the second volume of the series and covers the following topics: o Chromatographic assays of solid dosage forms and their drug dissolution studies o UHPLC method for the estimation of bioactive compounds o HILIC based LC/MS for metabolite analysis o In vitro methods for the evaluation of oxidative stress o Application of vibrational spectroscopy in studies of structural polymorphism of drugs o Electrochemical sensors based on conductive polymers and carbon nanotubes o Optical sensor arrays for pharmaceutical and biomedical analyses o Chemical applications of ionic liquids o New trends in enantioanalysis of pharmaceutical compounds
Author: Atta-ur- Rahman
Publisher: Bentham Science Publishers
ISBN: 1681085747
Category : Science
Languages : en
Pages : 466
Get Book
Book Description
Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents information about a selection of analytical techniques. Readers will find information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. Novel Developments in Pharmaceutical and Biomedical Analysis is the second volume of the series and covers the following topics: o Chromatographic assays of solid dosage forms and their drug dissolution studies o UHPLC method for the estimation of bioactive compounds o HILIC based LC/MS for metabolite analysis o In vitro methods for the evaluation of oxidative stress o Application of vibrational spectroscopy in studies of structural polymorphism of drugs o Electrochemical sensors based on conductive polymers and carbon nanotubes o Optical sensor arrays for pharmaceutical and biomedical analyses o Chemical applications of ionic liquids o New trends in enantioanalysis of pharmaceutical compounds
Author: Christopher M. Riley
Publisher: Elsevier
ISBN: 9780080530352
Category : Science
Languages : en
Pages : 349
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Book Description
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Author: G. Piemonte
Publisher: Springer Science & Business Media
ISBN: 1489935266
Category : Medical
Languages : en
Pages : 319
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Book Description
The papers collected in this volume were presented at an International Conference that, with the same heading, was held at the Verona University, Italy, in June 1986. The meeting was organized by the Institute of Forensic Hedicine and the Laboratory of Medical Research of the University in cooperation with the Italian Group for Mass Spectrometry in Biochemistry and Medicine. The aim of the symposium was bringing together people, work ing in different branches of the wide field of modern analytical sciences, for promoting inter-disciplinary discussions and exchange of experiences. Actually it was felt that most of the analytical problems that very often have to be faced in quite different fields (chem istry, pharmacology, medicine, biology) have similar solutions, that could be made much easier by closer contac'cs among researches of these disciplines. Original papers and invited rewiews presented during the 3 days of the conference by leading experts gave an up-to-date outline of the modern analytical methods applied in pharmaceuti cal, biomedical and forensic sciences and a glimpse of the future perspectives.
Author: Paraskevas D. Tzanavaras
Publisher: Bentham Science Publishers
ISBN: 1608051900
Category : Science
Languages : en
Pages : 160
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Book Description
"Reviews in Pharmaceutical and Biomedical Analysis contains coverage and review of new trends and applications in all areas of pharmaceutical, biomedical and analytical chemistry. Authors have contributed review articles according to their expertise on var"
Author: S.M. Lunte
Publisher: Elsevier
ISBN: 9780080538716
Category : Science
Languages : en
Pages : 508
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Book Description
The book describes the theory and applications of Capillary Electrophoresis (CE) in the field of pharmaceutical and biomedical analysis. It is targeted towards users who are intimately involved in analytical problems, especially those which involve small samples. This book presents the technique of capillary electrophoresis from the point of view of the serious hands-on use in the field of pharmaceutical and biomedical analysis. An overview of general theory is presented to acquaint the novice with the fundamental principles. A more theoretical approach is taken in the presentation of electrokinetic chromatography. The next chapter discusses advances in column technologies, the preceding chapters having provided a foundation as to how separations occur. In the next three chapters, recognized experts in their fields present fundamentals and state-of-the-art techniques in the areas of optical, electrochemical and mass spectrometric detection. The major focus of the remaining chapters is on applications. This includes the analysis of pharmaceuticals, amino acids and peptides, macromolecules, nucleosides, nucleotides and oligonucleotides. The use of CE for analysis of small ions and separation of biological particles is also discussed. The issue of sample preparation for analysis by CE is addressed, especially as it relates to clinical analysis.
Author: W.J. Lough
Publisher: Newnes
ISBN: 0080984541
Category : Medical
Languages : en
Pages : 393
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Book Description
This volume reflects the changes that have taken place in the pharmaceutical industry over the last ten years, most notably the increased importance attached to the question of chirality, the growing influence of biotechnology and the need for more rigorous documentation and validation of analytical methods and procedures. The first part of this book deals with the application of new technology to pharmaceutical and biomedical analysis, reflecting the present needs for increased speed, sensitivity and selectivity in the analysis of drugs. The second chapter provides an overview of capillary electophoresis, which represents one of the most inportant analytical developments to impact directly on pharmaceutical development in recent years. Although not a chromatographic technique, capillary electrophoresis was considered too important to be ignored. Over the last 25 years, liquid chromatography has grown into a mature analytical technique and many of the fundamental issues concerned with retention and separation are well defined. The practitioners of modern liquid chromatography spend as much time in the development of techniques for sampling handling and automation as they do in the development of the separation. Therefore, Part Two of this book describes some of the recent advances in the areas of sample handling and the isolation of compounds from biological samples, including solid phase extraction, restricted access media for direct injection, coupled column technology and microdialysis. Similarily, Part Three contains two chapters concerned with liquid chromatographic methods for the isolation of drug substances, peptides and proteins from other complex media. The pharmaceutical industry and the process of drug development are highly regulated and the increasing importance that the regulatory authorities attach to validation has had a significant impact on the analytical techniques used for the analysis of drugs. Although this has increased the workload of analysts in the pharmaceutical industry, it has also improved the quality of analytical methods used in the support of investigational and new drug applications as well as the quality of methods published more recently in the literature. Consequently, Part Four of this volume describes approaches to the optimization and validation of liquid chromatography methods for the analysis of drugs in the bulk form, in pharmaceutical formulations and biological fluids.
Author: David G. Watson
Publisher: Elsevier Health Sciences
ISBN: 0702069884
Category : Medical
Languages : en
Pages : 480
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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 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
Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080488927
Category : Medical
Languages : en
Pages : 587
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Book Description
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.
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527335633
Category : Medical
Languages : en
Pages : 451
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Book Description
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.
Author: Chukwuebuka Egbuna
Publisher: Academic Press
ISBN: 0128227990
Category : Science
Languages : en
Pages : 302
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Book Description
Analytical Techniques in Biosciences: From Basics to Applications presents comprehensive and up-to-date information on the various analytical techniques obtainable in bioscience research laboratories across the world. This book contains chapters that discuss the basic bioanalytical protocols and sample preparation guidelines. Commonly encountered analytical techniques, their working principles, and applications were presented. Techniques, considered in this book, include centrifugation techniques, electrophoretic techniques, chromatography, titrimetry, spectrometry, and hyphenated techniques. Subsequent chapters emphasize molecular weight determination and electroanalytical techniques, biosensors, and enzyme assay protocols. Other chapters detail microbial techniques, statistical methods, computational modeling, and immunology and immunochemistry. The book draws from experts from key institutions around the globe, who have simplified the chapters in a way that will be useful to early-stage researchers as well as advanced scientists. It is also carefully structured and integrated sequentially to aid flow, consistency, and continuity. This is a must-have reference for graduate students and researchers in the field of biosciences. Presents basic analytical protocols and sample-preparation guidelines Details the various analytical techniques, including centrifugation, spectrometry, chromatography, and titrimetry Describes advanced techniques such as hyphenated techniques, electroanalytical techniques, and the application of biosensors in biomedical research Presents biostatistical tools and methods and basic computational models in biosciences
