A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

A volume in the new Principles and Applications in Engineering series, Tissue Engineering provides an overview of the major physiologic systems of current interest to biomedical engineers: cardiovascular, endocrine, nervous, visual, auditory, gastrointestinal, and respiratory. It contains useful definitions, tables of basic physiologic data, and an introduction to the literature. Then, the book reviews the status of tissue engineering of specific organs, including bone marrow, skeletal muscle, and cartilage. Readers will acquire a good understanding of the engineering and cell biological fundamentals of tissue engineering and will develop ideas for further development of this emerging and important field.

One of Nature's most important talents is evolutionary development of systems capable of molecular recognition: distinguishing one molecule from another. Molecular recognition is the basis for most biological processes, such as ligandreceptor binding, substrate-enzyme reactions and translation and transcription of the genetic code and is therefore of universal interest. Over the past four decades, researchers have been inspired by Nature to produce biomimetic materials with molecular recognition properties, by design rather than by evolution. A particularly exciting area of biomimetics is Molecular Imprinting, which can be defined as process of template-induced formation of specific recognition sites (binding or catalytic) in a material where the template directs the positioning and orientation of the material's structural components by a self-assembling mechanism. The material itself could be oligomeric (the typical example is DNA replication process), polymeric (organic MIPs and inorganic imprinted silica gels) or 2-dimensional surface assembly (grafted monolayers). Essentially the current progress in the field of molecular imprinting is a result of fundamental achievements made by more than a hundred groups working in the areas of non-covalent and reversible covalent imprinting. The goal of this title is to capture this momentum and publish a new book that will reflect the current situation in this rapidly evolving technology. Very few of the tens of reviews already published on this subject present a critical analysis of the technological aspects of molecular imprinting. Leaders in this field have been approached with requests to provide their views and analyses of specific areas of design, characterization and application of these polymers. The main body of Molecular Imprinting of Polymers starts with chapters covering polymer design, synthesis, and characterization that are prepared by well-recognized experts such as Andrew Mayes and Natalia Perez-Moral, Claud

Biomimetics is the idea of creating new technologies abstracted from what we find in biology. Ocean Innovation: Biomimetics Beneath the Waves seeks that technological inspiration from the rich biodiversity of marine organisms. Bringing both a biological and engineering perspective to the biomimetic potential of oceanic organisms, this richly illustrated book investigates questions such as: How can we mimic the sensory systems of sea creatures like sharks, sea turtles, and lobsters to improve our ability to navigate underwater? What can we do to afford humans the opportunity to go unnoticed by marine life? How can we diffuse oxygen from water to enable deep diving without the risk of decompression sickness? Each chapter explores an area where we, as divers and technologists, can benefit from understanding how animals survive in the sea, presenting case studies that demonstrate how natural solutions can be applied to mankind's engineering challenges.

Over the past several decades there has been increasing research interest in thermodynamics as applied to biological systems. This concerns topics such as muscle work and internal energy such as fat and starch. Applications of the first and second laws of thermodynamics to the human body are important to dieticians and health science experts, and applications of these concepts to the animal body are a major concern of animal scientists. This book covers these key topics, which are typically not covered in classic or traditional thermodynamics texts used in mechanical and chemical engineering.

This book contains a comprehensive overview of all current uses of robots in rehabilitation. The underlying principles in each application are provided. This is followed by a critical review of the technology available, of the utilization protocols, and of user studies, outcomes, and clinical evidence, if existing. Ethical and social implications of robot use are also discussed. The reader will have an in depth view of rehabilitation robots, from principles to practice.

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.

Since the last major compendium dedicated to cyclic nucleotide phosphodiesterases (PDEs) was published over 15 years ago, an enormous amount of progress has occurred in the field. There is great need for a centralized source for key information in this burgeoning and therapeutically important area of medical research. Cyclic Nucleotide Phosphodiesterases in Health and Disease provides an integrated volume covering PDE biology from genes to organisms. It examines phosphodiesterases as pharmacological targets as well as the development of specific PDE inhibitors as therapeutic agents. With contributions from pioneers in the field, individual chapters describe one of the 11 known mammalian PDE families including the molecular characteristics, structure, function, and traits unique to each. Characteristics of PDEs from lower organisms are also the subject of other chapters since they provide key insights into PDE functions and are also pharmacological targets for treatment of a variety of diseases in humans and domestic animals. Chapters on the current biomedical and therapeutic research on PDEs include studies on gene-targeted knockout strategies and compartmentation in cyclic nucleotide signaling. By unraveling the unique cellular roles for different PDEs, scientists are beginning to open the door to the therapeutic use of PDE inhibitors for the treatment of a number of pathological conditions including asthma and inflammation, pulmonary hypertension, erectile dysfunction, and stroke. By collating current information into a coherent and coordinated perspective, Cyclic Nucleotide Phosphodiesterases in Health and Disease provides an invaluable reference for industry and clinical scientists and points toward future directions of research and therapeutic advancements in developing selective inhibitors for these various enzymes.

Largely driven by major improvements in the analytical capability of mass spectrometry, proteomics is being applied to broader areas of experimental biology, ranging from oncology research to plant biology to environmental health. However, while it has already eclipsed solution protein chemistry as a discipline, it is still essentially an extension of classical protein chemistry, owing much of its maturation to prior contributions. Unfortunately, this debt is not always evident in current literature. The Evolution from Protein Chemistry to Proteomics: Basic Science to Clinical Application, in providing a different perspective than other reviews, strengthens the connection between solution protein chemistry and proteomic technology. Towards this end, Roger Lundblad, a long-time leader in protein chemistry and a scientist who has worked in both academics and industry, brings together some seemingly disparate areas into a single volume. Discussing analytical proteomics, expression proteomics, and clinical proteomics (biomarker identification), he provides coverage that is uniquely rich in detail. Lundblad applies this detail to sample preparation for proteomic analysis, including preparation from blood and tissues. He also presents specifics on the prefractionation of samples used to identify specific subproteomes such as phosphoproteomes and glycoproteomes. Comprehensive reviews are provided covering the chemical modification of proteins, including its use for chemical proteomics. Special attention is given to challenges that impede the identification, validation, and development of biomarkers into clinically useful diagnostic analytes. A bestselling author, Lundblad utilizes classical protein chemistry literature in providing an intellectual basis for proteomics that merges current concepts with the existing literature, while providing the technical detail necessary for the effective commercialization of proteomics.

This book addresses knowledge gaps in RARP in 3 key sections: 1) Step-by-step approach including multiple technique options and innovations, 2) Patient selection, safety, outcomes, and 3) Preparing the patient for surgery. The order is more based upon knowledge priority rather than a chronologic sequence in which part 3 would go first. Part two allows more summary and commentary on evidence and part three allows some creative content that is otherwise hard to find in one place-medical evaluations, imaging, clinical trials, patient education, etc. This textbook emphasizes content for the advanced skills surgeon in that multiple techniques are presented as well as state of the art evidence. The learning curve is addressed and the authors clarify how this text is useful for learners. The caveat is that they should be careful in patient selection and stick with what their mentors are showing them. With experience, they can then branch out into the many techniques presented here. Robot-Assisted Radical Prostatectomy: Beyond the Learning Curve will also have cross-over appeal for surgical assistants, physician assistants, nurses, and anyone else involved in the surgical care of prostate cancer.

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing. This new text asks the question, "How can we use computational methods to improve the success rate in drug development?" Computer Techniques in Preclinical and Clinical Drug Development shows how modeling makes it possible to extract the maximum amount of information and predictive value from preclinical data. Computer modeling methods from the areas of pharmacokinetics, pharmacodynamics, cytokinetics, and inhibition kinetics of multi-enzyme pathways are all discussed in this unique reference source.

This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment. Examines excipients as a unique class of products and explores new procedures for determining toxicity! A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety identifies the differences between excipients (inactive ingredients), food ingredients, and drug products evaluates issues of dose administration, species selection, and study design for various routes of exposure provides detailed information on the historical uses of excipients in drug formulations clarifies the Safety Committee of the International Pharmaceutical Excipients Council's (IPEC) guidelines and technical specifications for conducting tests for each route of exposure explains how data generated in toxicity models are applied to identify hazards in drug formulations details exposure assessment to link hazard identification with risk considers the requirements and importance of purity specifications and much more! Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

Taking readers from the research laboratory to the bedside, this Second Edition compiles essential information on the pharmacodynamics of all major classes of the antimicrobial armamentarium including penicillins, cephalosposorins, cephamycins, carbapenems, monobactams, aminoglycosides, quinolones, macrolides, antifungals, antivirals, and emerging agents currently in development. Written by experienced professionals in the field, this guide uses an abundance of examples to depict methods to apply pharmacodynamic concepts to everyday clinical practice.

Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations, and the ethical issues. They cover contracting out laboratory analysis, data management, and statistical services, and the effects of outsourcing on quality assurance. Whether readers are beginning to explore the possibility of outsourcing or already involved in long-term strategic outsourcing partnerships, this invaluable resource is a complete guide to the drug development outsourcing relationship.

Once the existence of free radicals was proven, an avalanche of studies on free radical-mediated biological processes ensued. The study of reactive oxygen and nitrogen species (ROS and RNS) is center stage in biological free radical investigations. Written by a biochemist, Signaling Mechanisms of Oxygen and Nitrogen Free Radicals discusses the regulatory functions of ROS and RNS in physiological and pathophysiological states. An exploration of the main questions of signaling mechanisms of reactive oxygen and nitrogen species in enzymatic processes, this book draws attention to the chemical mechanisms of these reactions. It elucidates the differences between signaling functions and damaging effects of ROS and RNS in biological systems. The text also covers free radical signaling processes catalyzed by enzymes, producers of superoxide and nitric oxide that are able to use produced ROS and RNS as signaling species in their own catalytic processes. It then examines ROS and RNS signaling produced by mitochondrial enzymes. The author explores signaling functions of ROS and RNS in enzymatic heterolytic reactions, supplying important data on ROS and RNS signaling in the catalysis by the enzymes which do not produce free radicals by themselves. He provides information on signaling by reactive oxygen and nitrogen species in apoptosis and aging/senescence and concludes with coverage of mechanisms of free radical signaling in enzymatic processes. The book provides new understanding of signaling functions in living organisms related to cardiovascular processes, cancer, inflammation, hereditary diseases, and their regulation of physiological functions such as development, aging, and senescence. This information can support the development of new drugs and novel treatment methods.

Monoclonal antibodies have had their impact on biomedical research for more than a decade. Beside their exuberant use as reagents, quite a number of diagnostic and therapeutic approaches have been followed and an impressive number of technological improvements, e.g., humanization, recombinant miniantibodies, have been elaborated to strengthen the principle. With respect to clinical applications, the first generation of antibody 'drugs' is yielding promising results while second and third generation antibody constructs are already underway. The book reviews the status of technological development and brings this into the perspective of clinical results. A rapidly growing amount of clinical data is collected in an expanding number of indications. Hence, the review of clinical study results has been grouped according to the fields of oncology and of chronic and acute inflammation. This book will be of interest to scientists working in the fields of oncology, immunology, internal medicine and clinical chemistry.

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel ligands for different antimicrobial lipopeptides. Along with identification, it also provides some of the in silico drug design processes, namely homology modelling, molecular docking, QSAR studies, drug ADMET studies and pharmacophore studies to check the ligand-lipopeptide interaction. Some lipopeptides have shown anti-cancerous properties too, and this book discusses the required templates to design new drugs using computational techniques. Key Features: Focuses on the use lipopeptides as new antimicrobial compounds Presents the basics of in silico modelling for design and development of new drug molecules, and is therefore of interest to beginners in the field Provides a step-by-step process for identification of drug molecules and testing its efficacy in silico Couples with courses on patents and intellectual property rights

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

HIMSS' Certified Associate in Healthcare Information and Management Systems (CAHIMS) certification offers a pathway to careers in health information technology (health IT) for associate-level, emerging professionals, or those who would like to transition to health IT from other industries. The CAHIMS Review Guide, 2nd Edition is the ideal resource for those preparing for the CAHIMS certification exam-or looking for a comprehensive "health IT 101" guide. Content in this updated and revised CAHIMS review guide reflects the new CAHIMS exam content outline. Content is divided into three topic categories: organizational and technology environments; systems analysis, design, selection, implementation, support, maintenance, testing, evaluation, privacy, and security; and leadership and management support. Each chapter includes learning objectives for tracking progress in understanding and articulating the content. Practice exam questions at the end of the book reinforce key concepts explored throughout the book. This book is a comprehensive and timely introduction to healthcare information and management systems. It's also an invaluable resource for staying current in all aspects of the industry. In addition to sample exam questions, this book includes an overview of the eligibility requirements, testing procedures, and the CAHIMS examination itself.

There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book's website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others