This book focuses on a diverse range of disciplines, including pharmacy, sociology, social policy, psychology, anthropology, history and health economics, with contributors each bringing a unique perspective and insight into the practice of pharmacy.

Monoclonal antibodies have become important treatments for cancer, inflammation and a wide range of other diseases, representing an increasing share of the most successful pharmaceutical markets. The technologies to discover these drugs have been developed by select centers of excellence in industry and academia, and are continually being fine tuned in the race to identify the best antibody-based drug candidates and accelerate their paths to patients. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field and to offer specialized perspectives to established researchers. The chapters set into context the significance of key developments and important considerations for selecting different approaches, such as antibody humanization, isotype selection, lead candidate selection criteria and protein production. All contributors to this work are experts in their fields, and many have played pivotal roles in the creation of these technologies.

This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments. This edition has been updated to reflect significant trends and cutting-edge advances that have occurred since the first edition was published. All the original chapters have been retained, but the material therein has been updated. Eight new chapters have been added that deal with entirely new technologies and approaches.

An estimated 1 in 20 patients are admitted to the hospital due to problems with their medication and 1 in 100 hospitalized patients are harmed due to medication errors during their stay. The prescribing of medications is the most common health care intervention and medication safety is relevant to all health care professionals and patients, in all health care settings. Safety in Medication Use provides an overview of the theory and practice of medication safety, summarizing the international literature and practical suggestions for local practice Each chapter is written by one or more authors from around the world who were chosen because of their standing in their field. The book covers three broad areas: problems in the medication use process, approaches to understanding and resolving them, and putting solutions into practice. Topics discussed include: Measuring medication errors Improvement science Safety culture Incident reporting and feedback approaches Educational interventions Communication between health care professionals Interventions for safer work systems Electronic prescribing and medication administration record systems Innovations in dispensing Patient involvement in medication safety Each chapter is a primer on the topic, drawing on the international literature, with the chapters on solutions followed by an "expert summary" of the implications for practice. This valuable resource describes an international body of work that shows not only how widespread medication errors are, but also discusses interventions that can reduce such errors to improve patient safety.

Provides a unique tableau of the funeral director's world. As such, it is a contribution to the growing literature on death and dying. Like the study of deviance which aids understanding of the norms of society, the sociology of death uncovers many insights into the very structures and patterns which shape life.

If we will ever achieve Paul Ehrlich's "magic bullet," that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change. Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems seeks to address a trio of objectives that, though separate, are linked and central to biomedical science and, ultimately, medicine. Rather seeing these as separate "silos," those working in nonclinical safety assessment will have to view these three in an integrated manner and to regularly and thoughtfully incorporate new information and technology. The trio of objectives this book explores are: first, to present how to deliver more of a drug product systemically to facilitate the regulatory need for evaluating safety and efficacy in animal species (at elevated exposure levels) prior to advancing the drug to human testing; second is to achieve better tolerance to therapeutics administration in test animals and humans which achieves objectives 1 and 3; and third, to explore ways to improve on therapeutic target receptor delivery performance, therefore improving both clinical pharmacodynamics bioavailability and specificity. The book's ten chapters assemble the basic concepts, principles and hypotheses involved in quantitative receptor and chronological organism interaction dynamics central to the successful development of new therapeutics which depend on systemic administration to achieve desired therapeutic goals and in so doing avoid outcomes which limit, marginalize, or preclude the therapeutic use of so many molecules.

Written by an author with more than 40 years of teaching experience in the field, Experiments in Pharmaceutical Chemistry, Second Edition responds to a critical classroom need for material on directed laboratory investigations in biological and pharmaceutical chemistry. This new edition supplies 75 experiments, expanding the range of topics to 22 major areas of pharmaceutical chemistry. These include biochemical groups, botanical classes important to pharmacy, and major drug classifications: Carbohydrates Lipids Proteins Enzymes Inorganics Vitamins Steroids Plant Acids Flavonoids Alkaloids Tannins Resins Glycosides Gums Balsams Volatile Oils Analgesics Anesthetics Sulfa Drugs (Sulfonamides) Psychotropic Drugs Antibiotics Nucleic Acids Sections contain introductions to basic concepts underlying the fields addressed and a specific bibliography relating to each field. Each experiment provides detailed instructions in a user-friendly format, and can be carried out, in most cases, without the need for expensive instrumentation. This comprehensive laboratory manual offers much-needed instructional material for teaching laboratory classes in pharmaceutical chemistry. The breadth of subject matter covered provides a variety of choices for structuring a laboratory course.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation's knowledge assets can provide a path towards business excellence.

The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming establishe

This book presents new approaches for skin aging and photocarcinogenesis and topical formulations based on nanocarrier systems for skin disorders. It discusses cosmeceuticals, laser, photodynamic therapy, and melatonin-based treatments as important strategies for photoaging management. Photodynamic therapy and melatonin can be used in the photocarcinogenesis context, too. Therefore, the inclusion of this strong antioxidant in sunscreen products could be a promising approach. The book discusses topical formulations, including emulsions (conventional formulations and emulsions stabilized by solid particles), nail films, and nanocarriers used for the delivery of actives in various skin and nail diseases such as acne, psoriasis, atopic dermatitis, fungal diseases, leishmaniasis, and skin cancer. Finally, several nanocarriers are introduced, such as lipid vesicles (ranging from the first-generation conventional liposomes to the more recent deformable vesicles), liquid crystalline nanodispersions, gelatin, and solid lipid nanoparticles. Their composition, formulation, characterization, and topical applications are also discussed. Although this is a broad topic, the most important (nano)pharmaceutical formulations are presented in the book.

The first chapter in volume 111 summarizes research on the sesterterpenoids, which are known as a relatively small group of natural products. However, they express a variety of simple to complicated chemical structures. This chapter focuses on the chemical structures of sesterterpenoids and how their structures are synthesized in Nature. The second chapter is devoted to marine-derived fungi, which play an important role in the search for structurally unique secondary metabolites, some of which show promising pharmacological activities that make them useful leads for drug discovery. Marine natural product research in China in general has made enormous progress in the last two decades as described in this chapter on fungal metabolites. This contribution covers 613 new natural products reported from 2001 to 2017 from marine-derived fungi obtained from algae, sponges, corals, and other marine organisms from Chinese waters.

The six years that have passed since the publication of the first edition have brought significant advances in both biofilm research and biofilm engineering, which have matured to the extent that biofilm-based technologies are now being designed and implemented. As a result, many chapters have been updated and expanded with the addition of sections reflecting changes in the status quo in biofilm research and engineering. Emphasizing process analysis, engineering systems, biofilm applications, and mathematical modeling, Fundamentals of Biofilm Research, Second Edition provides the tools to unify and advance biofilm research as a whole. Retaining the goals of the first edition, this second edition serves as: A compendium of knowledge about biofilms and biofilm processes A set of instructions for designing and conducting biofilm experiments A set of instructions for making and using various tools useful in biofilm research A set of computational procedures useful in interpreting results of biofilm research A set of instructions for using the model of stratified biofilms for data interpretation, analysis, and biofilm activity prediction

A practical guide for chemists in the pharmaceutical industry to making automated analyses of drugs that will meet the standards of regulatory agencies. Reviews the standard techniques of high-performance liquid chromatography, specialized detection methods, automation in pharmaceutical analysis, an

Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

Fills a gap between the existing studies of proteins, which tend to be highly technical and geared toward the practicing protein chemist, and biochemistry textbooks, which focus on general principles. Scientists cover a dozen topics by presenting fundamental principles, an overview, and the practica

This book serves as a formulation and processing guide during the development of pelletized dosage forms. It provides the pharmaceutical technologist with basic information about the design aspects of the relevant processing equipment.

Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases. Bio-Targets and Drug Delivery Approaches is an easy-to-read book for students, researchers and pharmaceutical scientists providing a comprehensive introduction to the principles of advanced drug delivery and targeting their current applications and potential future developments.

The New Benchmark for Understanding the Latest Developments of Ion Channels Ion channels control the electrical properties of neurons and cardiac cells, mediate the detection and response to sensory stimuli, and regulate the response to physical stimuli. They can often interact with the cellular environment due to their location at the surface of cells. In nonexcitable tissues, they also help regulate basic salt balance critical for homeostasis. All of these features make ion channels important targets for pharmaceuticals. Handbook of Ion Channels illustrates the fundamental importance of these membrane proteins to human health and disease. Renowned researchers from around the world introduce the technical aspects of ion channel research, provide a modern guide to the properties of major ion channels, and present powerful methods for modeling ion channel diseases and performing clinical trials for ion channel drugs. Conveniently divided into five parts, the handbook first describes the basic concepts of permeation and gating mechanisms, balancing classic theories and the latest developments. The second part covers the principles and practical issues of both traditional and new ion channel techniques and their applications to channel research. The third part organizes the material to follow the superfamilies of ion channels. This part focuses on the classification, properties, gating mechanisms, function, and pharmacology of established and novel channel types. The fourth part addresses ion channel regulation as well as trafficking and distribution. The final part examines several ion channel-related diseases, discussing genetics, mechanisms, and pharmaceutical advances.

BioMedWomen 2015 - Clinical and BioEngineering for Womens Health contains all author contributions presented at BioMedWomen 2015 (Porto, Portugal, 20-23 June 2015). International contributions from countries worldwide provided comprehensive coverage of the current state-of-the-art on different topics: * Aging * Physical Activity and Sports * Physiotherapy * Aesthetic and Reconstructive Surgery * Urogynecology * Imaging * Biomechanics * Nutrition * Health Psychology * Assisted diagnosis and Treatment * Tissue Engineering * Medical Devices * Prosthesis * Dental care and Orthodontics BioMedWomen 2015 - Clinical and BioEngineering for Womens Health will be of interest to academics and to others interested and involved in clinical and engineering subjects related to womens health.

Most clinical laboratory tests utilize interstitial and extravascular such as blood, urine, cerebral spinal fluid (CSF), and saliva. For example, CSF is monitored in the context of cancer for both diagnostic and therapeutic reasons. And yet, our understanding of the makeup of interstitial fluids, their relationships to disease, as well as their commercial importance in therapeutics and diagnostics remains rudimentary. Although sometimes perceived as static, interstitial and extravascular fluids are surprisingly dynamic. More than half of serum albumin is in the extravascular space. These fluids move rapidly between the intravascular and extravascular spaces - one entire plasma volume is exchanged very nine hours. In the first half of the book, the authors cover fundamental concepts of interstitial fluids, including their composition and function. They then further review the mechanisms by which interstitial fluids are regulated, characterizing the importance of hyaluronan - a major constituent of interstitial spaces and an a component of synovial fluid; and, outlining the regulation of proteolysis in the interstitial space. In the second half of the book, the authors focus on the coagulation system. This system has been studied extensively in the context of vascular spaces. But many of its components exist in the interstitial spaces. Chapters are devoted to the fibrinolytic system, kallikrein, matrix metalloproteinases, coagulation factors, and protease inhibitors - all are interstitial. By covering a unique array of topics with broad application to biomedical scientists, this book expands our understanding of the importance of interstitial spaces and the fluids that move through and reside in this extravascular environment.

Electrochemical Detection in HPLC: Analysis of Drugs and Poisons is the first monograph devoted to the application of this mode of analysis to the assay of exogenous compounds such as drugs in biological fluids and associated areas. The introductory chapters provide information on basic electrochemistry and HPLC-ED, and on trouble-shooting. The specialized area of thiol analysis is also discussed in detail. Salient practical details of published applications of the technique in analytical toxicology and related areas are provided in a standard format. Alternative techniques are suggested throughout. The emphasis is on the analysis of exogenous compounds, although catecholamines and other endogenous species are discussed in so far as they may be used as drugs. The practical nature of this book will make it useful to professionals working in the field. It will also be of benefit to analysts wishing to use HPLC-ED in the analysis of biological samples for analytes not specifically covered in the volume.

Guides You on the Development and Implementation of B-R Evaluations Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B-R assessments in medicine development and regulation, the need for both a common B-R framework and patient input into B-R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA's Center for Devices and Radiological Health. The third section examines key elements of B-R evaluations in a product's life cycle, such as uncertainty evaluation and quantification, quantifying patient B-R trade-off preferences, ways to identify subgroups with the best B-R profiles, and data sources used to assist B-R assessment. The fourth section equips practitioners with tools to conduct B-R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B-R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B-R evaluations.

Accounts in Drug Discovery describes recent case studies in medicinal chemistry with a particular emphasis on how the inevitable problems that arise during any project can be surmounted or overcome. The Editors cover a wide range of therapeutic areas and medicinal chemistry strategies, including lead optimization starting from high throughput screening "hits" as well as rational, structure-based design. The chapters include "follow-ons" and "next generation" compounds that aim to improve upon first generation agents. This volume surveys the range of challenges commonly faced by medicinal chemistry researchers, including the optimization of metabolism and pharmacokinetics, toxicology, pharmaceutics and pharmacology, including proof of concept in the clinic for novel biological targets. The case studies include medicinal chemistry stories on recently approved and marketed drugs, but also chronicle "near-misses", i.e., exemplary compounds that may have proceeded well into the clinic but for various reasons did not result in a successful registration. As the vast majority of projects fail prior to registration, much can be learned from such narratives. By sharing a wide range of drug discovery experiences and information across the community of medicinal chemists in both industry and academia, we believe that these accounts will provide insights into the art of medicinal chemistry as it is currently practiced and will help to serve the needs of active medicinal chemists.