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The scientific monograph by the author Peter Mikus entitled "Chiral Capillary Electrophoresis in Current Pharmaceutical and Biomedical Analysis" provides a comprehensive view on the advanced capillary electrophoresis techniques aimed to current chiral bioanalysis. The advances in the chiral electrophoresis analytical approaches are divided and theoretically described in three sections involving (i) advanced chiral separations for the optimization of chiral resolution (separation mechanisms; electrophoresis techniques in capillary and microchip format; electrophoretic modes such as ITP, CZE/EKC, CEC; chiral additives / pseudophases / phases), (ii) advanced sample preparation for the on-line preconcentration, sample clean-up and analyte derivatization (implementation of electrophoretic effects such as stacking; non-electrophoretic effects such as SPE, chromatography, dialysis; combinations of these effects; multidimensional CE systems; instrumental schemes), (iii) advanced combinations of detection and electrophoresis for the optimization in qualitative and quantitative evaluation (the most important universal as well as selective detection approaches such as absorption and fluorescence spectrophotometry, electrochemical detection, mass spectrometry vs. (i) and/or (ii)). Real analytical potential (benefits and limitations) of these advanced analytical approaches is emphasized by selected performance parameters of the methods and illustrated by many current practical applications including chiral analyses of drugs, their (bio)degradation products and biomarkers in pharmaceutical and biological matrices. The author wishes the readers many inspirations in the creation of new innovative approaches in the field of advanced chiral electrophoresis techniques with the aim to overcome capabilities of the current analytical techniques.
Covers the Fundamentals of Chiral Separation, Available Chiral Selectors, and Numerous Applications of Chiral Separation by Capillary ElectrophoresisSince the 1980s, modern analytical tools have enabled capillary electrophoresis to become a standard part of the chemist's toolkit. With contributions from international experts, Chiral Separations by
Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control.- Provides current status and future developments in CE analysis of pharmaceuticals.- Explains how to develop and validate methods.- Includes major pharmaceutical applications including assays and impurity testing.
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. - Presents a critical assessment of the application of ICH guidelines on method validation and specification setting - Written by subject-matter experts involved in the development and application of the guidelines - Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products - Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
While working as a chromatographer in the pharmaceutical industry, it became apparent to the editor that there was a pressing need for a comprehensive reference text for analysts working on the resolution of enantiomers by liquid chromatography (LC). This need arises from the fact that, whereas previously it was very difficult to determine enantiomers by direct means, there is now a wide choice of direct LC methods. At the same time, regulatory authorities have been changing their attitudes towards the administration of pharmaceuticals as racemates, partly because it is now possible to study the individual enantiomers. Clearly this abundance of new information needs to be rationalized. More importantly, the chiral LC systems which are commercially available or readily accessible to the practising chromatographer needed to be reviewed and, to a much greater extent than in existing reviews or books, discussed in terms of their practical application. Accordingly this book is very much orientated towards the practical aspects of these commercially available and readily accessible chiral LC systems. To this end, it is written for practising chromatographers by a team of practising, experienced chromatographers who have spent many years tackling the problems presented by resolving enantiomers by LC. The practical aspects of common chiral LC systems cannot be fully understood if discussed in isolation.
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
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
In all different areas in biomedical engineering, the ultimate objectives in research and education are to improve the quality life, reduce the impact of disease on the everyday life of individuals, and provide an appropriate infrastructure to promote and enhance the interaction of biomedical engineering researchers. This book is prepared in two volumes to introduce a recent advances in different areas of biomedical engineering such as biomaterials, cellular engineering, biomedical devices, nanotechnology, and biomechanics. It is hoped that both of the volumes will bring more awareness about the biomedical engineering field and help in completing or establishing new research areas in biomedical engineering.
Endlich ein Forschungsleitfaden für Wissenschaftler des Fachgebiets, die neue Methoden entwickeln oder einsetzen. Dieses Handbuch umfasst fünf thematische Bände und bietet damit einen umfassenden Überblick über das Fachgebiet. Erläutert werden Grundlagen, die Methodenentwicklung und hochkarätige Anwendungen für alle wichtigen Analyseverfahren, darunter chromatische Verfahren, Techniken in den Bereichen Elektromigration und Membranen. Dieses Referenzwerk umfasst ein breites Spektrum und legt den Schwerpunkt auf Entwicklungen für die Zukunft. Damit ist es ein Muss für Forscher und eine wertvolle Wissensquelle für Studenten im Hauptstudium und Studienabsolventen.
Now in its third edition, this bestselling work continues to offer state-of-the-art information on the development and employment of capillary electrophoresis. With special emphasis on microseparations and microfluidics, it features new chapters describing the use of microchip electrophoresis and associated microtechniques, with a focus on the extraordinary breadth of work undertaken to expand CE methodologies in recent years. Enhanced by contributions from leading international experts, the Handbook of Capillary and Microchip Electrophoresis and Associated Microtechniques, Third Edition remains a seminal reference for the chemistry, biology, and engineering fields.