The microfluidic lab-on-a-chip allows scientists to conduct chemical and biochemical analysis in a miniaturized format so small that properties and effects are successfully enhanced, and processes seamlessly integrated. This microscale advantage translates into greater sensitivity, more accurate results, and better information. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery focuses on all aspects of the microfluidic lab-on-a-chip technologies and offers an overview of the available technology, its limitations, and its breakthroughs over the years. It emphasizes analytical applications of microfluidic technology and offers in-depth coverage of micromachining methods, microfluidic operations, chemical separations, sample preparation and injection methods, detection technology, and various chemical and biological analyses. Other topics of interest include the use of polymeric chips, fluid flow valve and control, single-cell analysis, DNA and RNA amplification techniques, DNA hybridization, immunoassays and enzymatic assays. Originally conceived as a single chapter published in Ewing's Analytical Instrumentation, this book is a gateway to the vast literature and conference proceedings on the topic. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery expands upon its roots to present a comprehensive treatment of microfluidic lab-on-a-chip methods and applications for novices and advanced researchers alike.

Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug

Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.

Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Fluorescence of Living Plant Cells for Phytomedicine Preparations reveals how valuable medicinal compounds can be identified through the application of vital fluorescence in plant cells. The book explains the roles that fluorescent compounds play in plant physiology and promotes our knowledge of plant secretory cells and phytopreparations. Supported by vivid illustrations, the book reveals how actinic light - light that induces fluorescence in leaves and flowers - can be used in the identification of secretory cells within plant tissue that may be the repository of valuable medicinal compounds. The book demonstrates the potential of fluorescence in pharmacological analysis with detailed methods for applying fluorescence to identify these deposits of natural drugs. As such, this groundbreaking book contains methods of express-pharmaceutical analysis that could open new horizons in pharmacy and the cultivation of medicinal plants. Features Describes various fluorescence microscopy techniques for the localization of compounds contained in plants with pharmaceutical interest Provides an analysis of pharmaceutical material based on autofluorescence and histochemical reactions for numerous medicinal plant species Demonstrates practices for providing optimal growing conditions and improving the quality of the compounds Showing the readiness of plant raw material for pharmaceutical industry, this book will appeal to professionals in the pharmaceutical industry and students and researchers in the fields of phytochemistry, botany and pharmaceutical sciences.

1) Discusses the affordability of future therapy and the possible challenges for health insurance systems 2) Highlights the gradual move from repeated treatment administration to one single administration with potential for a definite cure 3) Describes the potential change of paradigm which will challenge all payers and may question the sustainability of our health care systems

Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.

Describing recent developments in the engineering and generation of plants as production platforms for biopharmaceuticals, this book includes both vaccines and monoclonal antibodies. It has a particular emphasis on targeting diseases which predominate in less developed countries, encompassing the current state of technologies and describing expression systems and applications. This book also includes a variety of vaccine case studies, protecting against pervasive infectious diseases such as rabies, influenza and HIV.

"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "

Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date, complete reference, Thin Layer Chromatography in Drug Analysis covers the most important methods in pharmaceutical applications of TLC, namely, analysis of bulk drug material and pharmaceutical formulations, degradation studies, analysis of biological samples, optimization of the separation of drug classes, and lipophilicity estimation. The book is divided into two parts. Part I is devoted to general topics related to TLC in the context of drug analysis, including the chemical basis of TLC, sample pleparation, the optimization of layers and mobile phases, detection and quantification, analysis of ionic compounds, and separation and analysis of chiral substances. The text addresses the newest advances in TLC instrumentation, two-dimensional TLC, quantification by slit scanning densitometry and image analysis, statistical processing of data, and various detection and identification methods. It also describes the use of TLC for solving a key issue in the drug market-the presence of substandard and counterfeit pharmaceutical products. Part II provides an in-depth overview of a wide range of TLC applications for separation and analysis of particular drug groups. Each chapter contains an introduction about the structures and medicinal actions of the described substances and a literature review of their TLC analysis. A useful resource for chromatographers, pharmacists, analytical chemists, students, and R&D, clinical, and forensic laboratories, this book can be utilized as a manual, reference, and teaching source.

Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis. The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.

Drug Delivery Trends examines a drift in the pharmaceutical field across the wide range of dosage forms, drug delivery systems (micro and nanoparticulate), at the regulatory front and on new types of therapies in the market. This volume additionally covers the challenges on drug delivery systems in terms of preclinical and current ways of determining quality and the options to solve the challenges associated with this. Most small-medium scale industries and academics struggle with initial regulatory challenges so a detailed discussion on regulatory trend covers the necessary basic understanding of regulatory procedures and provides the required guidance. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems.

The drug discovery and development process is getting longer, more expensive, and no better. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of Drug Discovery: From Target Selection Through Lead Optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. The book explores early successes, examines the current state of the art, and provides a strategic analysis of the issues currently facing drug discovery. Introducing the historical background and current status of the industry, the book delineates the basic tenets underlying modern drug discovery, how they have evolved, and their use in various approaches and strategies. It examines, in detail, the regulations, requirements, guidelines, and draft documents that guide so many FDA actions. The editor devotes the remainder of the discussion to industrialization, compound and knowledge management functions, the drug screening process, collaboration, and finally, ethical issues. Drawing on real-life, from-the-trenches examples, the book elucidates a new approach to drug discovery and development. This modern-day, back-to-basics approach includes three steps: understand the science, unravel the story, and then intelligently apply the technology, bringing to bear the entire armamentarium of industrialization techniques, not just automation, to the discovery process. Using these steps, you can meet the goals of more specific targets, more selective compounds, and decreased cycle times. In effect, you can look for a bigger needle in a smaller haystack. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.

This book discusses fabrication of functionalized gold nanoparticles (GNPs) and multifunctional nanocomposites, their optical properties, and applications in biological studies. This is the very first book of its kind to comprehensively discuss published data on in vitro and in vivo biodistribution, toxicity, and uptake of GNP by mammalian cells providing a systematization of data over the GNP types and parameters, their surface functionalization, animal and cell models. As distinct from other related books, Gold Nanoparticles in Biomedical Applications discusses the immunological properties of GNPs and summarizes their applications as an antigen carrier and adjuvant in immunization for the preparation of antibodies in vivo. Although the potential of GNPs in nanobiotechnology has been recognized for the past decade, new insights into the unique properties of multifunctional nanostructures have recently emerged. With these developments in mind, this book unites ground breaking experimental data with a discussion of hybrid nanoparticle systems that combine different nanomaterials to create multifunctional structures. These novel hybrids constitute the material basis of theranostics, bringing together the advanced properties of functionalized GNPs and composites into a single multifunctional nanostructure with simultaneous diagnostic and therapeutic functions. Such nanohybrids can be physically and chemically tailored for a particular organ, disease, and patient thus making personalized medicine available.

This volume provides an overview of the development and scope of molecular biophysics and in-depth discussions of the major experimental methods that enable biological macromolecules to be studied at atomic resolution. It also reviews the physical chemical concepts that are needed to interpret the experimental results and to understand how the structure, dynamics, and physical properties of biological macromolecules enable them to perform their biological functions. Reviews of research on three disparate biomolecular machines-DNA helicases, ATP synthases, and myosin--illustrate how the combination of theory and experiment leads to new insights and new questions.

This is a timely collection of important biomedical applications for a set of separation/characterization techniques that are rapidly gaining popularity due to their wide dynamic range, high resolution, and ability to function in most commonly used solvent systems. Importantly, the field-flow fractionation (FFF) technique has recently emerged as a prominent complement to size exclusion chromatography for protein pharmaceuticals. Fractionation with FFF is gentle and preserves protein structural integrity better than existing alternatives. In the present text, different chapters are written by experts in their respective field of application, who offer comparisons between the FFF techniques and other methods for characterizing their special focus material. Practical guide-lines for successful implementation, such as choice of operating conditions, are offered in conjunction with each application. In addition to new instrumentation and approaches that address important current topics, readers are provided with an overall sense of prior (but timeless) major developments that may be overlooked in literature searches.

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This book details chiroptical spectroscopic methods: electronic circular dichroism (ECD), optical rotatory dispersion (ORD), vibrational circular dichroism (VCD), and vibrational Raman optical activity (VROA). For each technique, the text presents experimental methods for measurements and theoretical methods for analyzing the experimental data. It also includes a set of experiments that can be adopted for undergraduate teaching laboratories. Each chapter is written in an easy-to-follow format for novice readers, with necessary theoretical formalism in appendices for advanced readers.

Structure-Based Drug Design brings together scientists working on different aspects of the subject, demonstrating the necessary collaboration and interdisciplinary approach to this complex area. The focus is on X-ray crystallographic and computational approaches. The general aspects of these approaches are introduced in the first six articles. The remaining articles provide examples of the application of X-ray crystallography, molecular modelling, molecular dynamics, QSAR, database analysis, and homology modelling. The papers cover a wealth of interesting problems in the design of new and enhanced pharmaceuticals.

Thin layer chromatography (TLC) is well suited for performing enantioseparations for research as well as larger-scale applications. A fast, inexpensive, and versatile separation technique, there are many practical considerations that contribute to its effectiveness. Thin Layer Chromatography in Chiral Separations and Analysis is the first book to focus solely on the theory, capabilities, and applications of TLC for direct and indirect enantioseparations. The first part of the book examines the fundamental principles of chirality and TLC. It describes the necessary materials, laboratory equipment, procedures, and strategies for the separation, quantification, isolation, and analysis of chiral compounds. The second part evaluates the real-world enantioseparations and densitometric analyses. Emphasizing pharmaceutical applications, the book discusses chiral separation mechanisms and methods for analyzing the chiral purity of diastereoisomers, amino acids, beta-blockers, and NSAIDS. Topics also include commercial stationary phases and chiral modifiers of mobile phases. Thin Layer Chromatography in Chiral Separations and Analysis presents a unified perspective of theory and experimental details underlying the collective developments in the field. The book offers scientists in a variety of disciplines and levels of expertise a complete guide to understanding the current and potential applications of chiral TLC.

Molecular Evolutionary Models in Drug Discovery explores the application of evolutionary molecular models in drug discovery in which secondary metabolites play a fundamental role. Secondary metabolites are not produced in isolation, they are the result of the interaction of genes, metabolism and the environment. The book examines the role of secondary metabolites as leads in drug discovery and on the development of a rational bioprospecting model for new medicines based on the evolution of secondary metabolism. These evolutionary models are part of biological systems and are the most reliable expression of the functioning of living beings.

The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic's success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.

Nanopharmaceuticals reviews advances in the drug delivery field via nanovehicles or nanocarriers that offer benefits like targeted therapy and serves as a single dose magic bullet for multiple drug delivery with improved drug efficiency at a lower dose, transportation of the drug across physiological barriers as well as reduced drug-related toxicity. The chapters are written by a diverse group of international researchers from industry and academia. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems. Other volumes in the Expectations and Realities of Multifunctional Drug Delivery Systems book series: Delivery of Drugs, Volume 2, 9780128177761 Drug Delivery Trends, Volume 3, 9780128178706 Drug Delivery Aspects, Volume 4, 9780128212226

This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the "lessons learnt" and "future developments".

Since the discovery of Aquaporin-1 (AQP1) as a water channel, many studies have revealed the importance of aquaporins in mammalian physiology and pathophysiology as well as plant and microbial biology. The studies have also shown aquaporins as potential drug targets and targets for improving crop properties. Written by an international group of contributors at the forefront of the field, Aquaporins in Health and Disease: New Molecular Targets for Drug Discovery presents the latest research advances in aquaporins and other major intrinsic protein (MIP) channels. The first section of the book describes the general concepts of aquaporin channel function, genomic research, structure-function analysis of aquaporins and glycerol facilitators, and regulation by gating and trafficking, including yeast aquaporin regulation and function. The second section discusses the physiological and pathophysiological roles of aquaporins in humans and microbes. The final section covers the development of inhibitors of aquaporin function. The book's epilogue offers future perspectives and directions, mainly in the area of aquaporin-based diagnostics and therapeutics. Stimulating future research on this important protein family, this book facilitates a paradigm shift in the understanding and roles of aquaporin membrane proteins in all biological settings. It encourages scientists to develop novel approaches for the treatment of human diseases based on aquaporin function or dysfunction.

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.