Novel Developments In Pharmaceutical And Biomedical Analysis
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Novel Developments in Pharmaceutical and Biomedical Analysis by Atta-ur- Rahman,Sibel A. Ozkan,Rida Ahmed Pdf
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
Reviews in Pharmaceutical and Biomedical Analysis by Paraskevas D. Tzanavaras,Constantinos K. Zacharis Pdf
"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"
Developments in Analytical Methods in Pharmaceutical, Biomedical, and Forensic Sciences by G. Piemonte,F. Tagliaro,M. Marigo Pdf
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.
Development and Validation of Analytical Methods by Christopher M. Riley,Thomas W. Rosanske Pdf
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.
Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences by Andrei A. Bunaciu,Hassan Y. Aboul-Enein,Vu Dang Hoang Pdf
Vibrational Spectroscopy Applications in Biomedical, Pharmaceutical and Food Sciences synthesizes the latest research on the applications of vibrational spectroscopy in biomedical, pharmaceutical and food analysis. Suitable for graduate-level students as well as experienced researchers in academia and industry, this book is organized into five distinct sections. The first deals with the fundamentals of vibrational spectroscopy, with the second presenting the most important sampling methodology used for infrared and Raman spectroscopy in various fields of interest. Since spectroscopy is the study of the interaction of electromagnetic radiation with matter, this section deals with the characteristics, properties and absorption of electromagnetic radiation. Final sections describe the analytical studies performed all over the world in biomedical, pharmaceutical and in the food sciences. Presents a critical discussion of many of the applications of vibrational spectroscopy Covers details of the analytical methodologies used in pharmaceutical and biomedical applications Discusses the latest developments in pharmaceutical and biomedical analysis of both small and large molecules
Pharmaceutical and Biomedical Applications of Liquid Chromatography by W.J. Lough,I.W. Wainer,Christopher M. Riley Pdf
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.
Pharmaceutical Analysis E-Book by David G. Watson Pdf
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
High Throughput Bioanalytical Sample Preparation by David A. Wells Pdf
High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies is an authoritative reference on the current state-of-the-art in sample preparation techniques for bioanalysis. This book focuses on high throughput (rapid productivity) techniques and describes exactly how to perform and automate these methodologies, including useful strategies for method development and optimization. A thorough review of the literature is included within each of these chapters describing high throughput sample preparation techniques: protein removal by precipitation; equilibrium dialysis and ultrafiltration; liquid-liquid extraction; solid-phase extraction; and various on-line techniques. The text begins with an introductory overview of the role of bioanalysis in pharmaceutical drug development. Fundamental understanding of the strategies for sample preparation is reinforced next, along with essential concepts in extraction chemistry. Several chapters introduce and discuss microplates, accessory products and automation devices. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The subject material then reviews protein precipitation, liquid-liquid extraction, solid-phase extraction and various on-line sample preparation approaches. The book concludes with information on recent advances in sample preparation, such as solid-phase extraction in a card format and higher density extraction plates. Important objectives that can be accomplished when the strategies presented in this book are followed include: improved efficiency in moving discovery compounds to preclinical status with robust analytical methods; return on investment in automation for sample preparation; and improved knowledge and expertise of laboratory staff. · Shows the reader exactly how to perform modern bioanalytical sample preparation techniques, complete with detailed strategies · Thorough literature review and summary of published information · Detailed discussion and examples of the method development process
Handbook of Modern Pharmaceutical Analysis by Satinder Ahuja,Stephen Scypinski Pdf
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.
Spectroscopic Analyses by Eram Sharmin,Fahmina Zafar Pdf
The book presents developments and applications of these methods, such as NMR, mass, and others, including their applications in pharmaceutical and biomedical analyses. The book is divided into two sections. The first section covers spectroscopic methods, their applications, and their significance as characterization tools; the second section is dedicated to the applications of spectrophotometric methods in pharmaceutical and biomedical analyses. This book would be useful for students, scholars, and scientists engaged in synthesis, analyses, and applications of materials/polymers.
New Developments in Nanosensors for Pharmaceutical Analysis by Sibel A. Ozkan,Afzal Shah Pdf
New Developments for Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemical nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications. Presents nanosensor types, synthesis, immobilizations and applications in different fields Gives simple repeatable designs for the fabrication of sensors for pharmaceutical analysis Details how to carry out sensitive analysis of pharmaceuticals using nanosensors Describes how to synthesize and immobilize nanosensors, and how nanosensors can be applied in drug assay Proposes innovative ways to optimize pharmaceutical processes with nanosensors
Recent Advances in Analytical Techniques by Atta-ur-Rahman,Sibel A. Ozkan Pdf
Recent Advances in Analytical Techniques is a series of updates in techniques used in chemical analysis. Each volume presents a selection of chapters that explain different analytical techniques and their use in applied research. Readers will find updated information about developments in analytical methods such as chromatography, electrochemistry, optical sensor arrays for pharmaceutical and biomedical analysis. The third volume of the series features seven reviews on a variety of techniques: · Chiral Analysis of Methamphetamine and Related Controlled Substances in Forensic Science · Low-cost feedstocks for biofuels and high value added products production: Using multi-parameter flow cytometry as a tool to enhance the process efficiency · Recent Trends in the Application of Ionic Liquids for Micro Extraction Techniques · Electrospun Nanofibers: Functional and Attractive Materials for the Sensing and Separation Approaches in Analytical Chemistry · Neutron Activation Analysis: An Overview · Non-commercial Polysaccharides-based Chiral Selectors in Enantioselective Chromatography · Ru(II)-polypyridyl Complexes as Potential Sensing Agents for Cations and Anions.
Business Development for the Biotechnology and Pharmaceutical Industry by Martin Austin Pdf
In recognition of the sparse information available to practitioners in the field of business development, Martin Austin has drawn on his 30 years of experience in the pharmaceutical industry to provide this highly practical guide spanning the complete process. Based on the well-established training programme he has developed and delivers to pharmaceutical executives from across the world, this book will help expand your knowledge in this immense area.
Specification of Drug Substances and Products by Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley Pdf
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD) Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity
Handbook of Pharmaceutical Analysis by HPLC by Satinder Ahuja,Michael Dong Pdf
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