Analytical Techniques in the Pharmaceutical Sciences


Book Description

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.




Introduction to Pharmaceutical Analytical Chemistry


Book Description

Die umfassend überarbeitete 2. Auflage enthält ein neues Kapitel zur chemischen Analyse von Biopharmazeutika, in dem die Identifizierung, Reinheitsprüfung und die Analyse on Peptiden und proteinbasierten Formulierungen erläutert werden. Die neue Auflage bietet ebenfalls verbesserte farbige Abbildungen und Tabellen, eine gestraffte Kapitelstruktur und überarbeitete Inhalte, die das Fachgebiet klarer und verständlicher präsentieren. - Bietet eine Einführung in die grundlegenden Konzepte der pharmazeutischen analytischen Chemie und Statistik. - Untersucht systematisch pharmazeutische Anwendungen, die in anderen Lehrbüchern zu dem Fachgebiet fehlen. - Untersucht verschiedene Analysetechniken, die in der Regel in Pharmalaboren zur Anwendung kommen. - Präsentiert Fragestellungen aus der Praxis, aktuelle praktische Beispiele und detaillierte Illustrationen. - Die aktualisierten Inhalte entsprechen den aktuellen europäischen und US-amerikanischen Arzneibuchvorschriften und -richtlinien.




Introduction to Pharmaceutical Chemical Analysis


Book Description

This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples




Handbook of Modern Pharmaceutical Analysis


Book Description

Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS




Analytical Techniques in Biosciences


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




Essentials of Pharmaceutical Analysis


Book Description

Recent advances in the pharmaceutical sciences and biotechnology have facilitated the production, design, formulation and use of various types of pharmaceuticals and biopharmaceuticals. This book provides detailed information on the background, basic principles, and components of techniques used for the analysis of pharmaceuticals and biopharmaceuticals. Focusing on those analytical techniques that are most frequently used for pharmaceuticals, it classifies them into three major sections and 19 chapters, each of which discusses a respective technique in detail. Chiefly intended for graduate students in the pharmaceutical sciences, the book will familiarize them with the components, working principles and practical applications of these indispensable analytical techniques.




Handbook of Pharmaceutical Analysis


Book Description

Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.




Drug Stereochemistry


Book Description

Maintaining and enhancing its focus on key issues in the development, regulatory approval and use of stereoisomeric compounds, this edition continues to cover in detail all aspects of chiral drugs from the academic, governmental, industrial and clinical points of view.;Completely rewritten and updated throughout, Drug Stereochemistry: illustrates current indirect chromatographic methods for the resolution of drug enantiomers; treats the rapidly growing area of enantioselective gas chromatography; discusses the latest in HPLC resolution of enantiomeric drugs; uses verapamil as a model to show how stereoselective pharmacokinetics affect pharmacodynamics; and supplies an in-depth study on the effect of stereoselective plasma protein binding.;This edition offers entirely new chapters that: discuss the recent decisions and present position of the US Food and Drug Administration on the development of stereoisomeric drugs; explicate enzymatic synthesis of stereochemically pure drugs; review the toxicological, pharmacokinetic and pharmacodynamic differences found among stereoisomers; elucidate the stereoselective transport of drugs across epithelia; and give a physician's perspective on the questions and problems caused by stereoisomeric drugs in practice as well as the pharmaceutical industry's collective viewpoint based on a national survey.




MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES


Book Description

In the ever-evolving landscape of pharmaceutical sciences, the role of analytical techniques cannot be overstated. The quality, safety, and efficacy of pharmaceutical products hinge upon the precision and reliability of analytical methods employed throughout their development, manufacturing, and regulatory approval processes. The past few decades have witnessed remarkable strides in analytical instrumentation, methodologies, and data analysis, catalyzing a paradigm shift in pharmaceutical analytics. This book is conceived as a comprehensive guide to modern pharmaceutical analytical techniques, aiming to bridge the gap between theoretical knowledge and practical application in the dynamic pharmaceutical industry. It is designed to serve as an invaluable resource for students, researchers, and professionals engaged in pharmaceutical analysis, providing a systematic overview of the state-of-the-art analytical tools and strategies employed in drug discovery, development, and quality control. Each chapter is meticulously crafted to deliver comprehensive insights into the theoretical foundations, practical considerations, and recent advances pertinent to the respective analytical technique, supplemented with illustrative examples, case studies, and critical discussions. Moreover, special attention is devoted to emerging trends, such as nanotechnology-enabled analytical platforms, microfluidic-based assays, and in silico predictive modeling, underscoring the transformative potential of cutting-edge technologies in reshaping the landscape of pharmaceutical analytics. It is our fervent hope that this book will serve as a catalyst for fostering interdisciplinary collaboration, driving innovation, and advancing best practices in pharmaceutical analytical sciences. We extend our sincere gratitude to the contributors for their scholarly contributions and dedication, as well as to the readers for their interest and engagement in this endeavor.




Pharmaceutical Analysis


Book Description

The use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.