A thorough treatment of product and systems development in terms of value to all stakeholders Product and Systems Development compiles more than twenty years of research and practice from a value perspective, from vision and marketing to design, manufacturing, delivery, operations, and maintenance. It defines stakeholder value and identifies specific stakeholders in the product and system development process; covers best practices in development; and examines systems engineering, current industry views, and the life cycle of a value stream. Featuring appendices written by professionals in the field on topics such as Design Structure Matrices, Lean Enablers for systems engineering, and MDAO and simulations, this indispensable guide: Explains why stakeholders' values can hold the key to fulfillment or defeat of the developer's vision Emphasizes the succession of value-contributing practices and tools that form a framework for development success Integrates the technical, productivity, and customer/end-user elements in product and system development Uses more than 100 tables and figures to illustrate the above processes, as well as corollary elements of risk, failure analysis, and fault-tolerant design Includes numerous case studies and links to online material Product and Systems Development is an excellent coursebook for senior and graduate students in aerospace, mechanical, civil, electrical, and material engineering, as well as management science and engineering. It is also a useful reference for practicing engineers in a variety of technology-based industries.
Cost-effective strategies for designing novel drug delivery systems that target a broad range of disease conditions In vivo imaging has become an important tool for the development of new drug delivery systems, shedding new light on the pharmacokinetics, biodistribution, bioavailability, local concentration, and clearance of drug substances for the treatment of human disease, most notably cancer. Written by a team of international experts, this book examines the use of quantitative imaging techniques in designing and evaluating novel drug delivery systems and applications. Drug Delivery Applications of Noninvasive Imaging offers a full arsenal of tested and proven methods, practices and guidance, enabling readers to overcome the many challenges in creating successful new drug delivery systems. The book begins with an introduction to molecular imaging. Next, it covers: In vivo imaging techniques and quantitative analysis Imaging drugs and drug carriers at the site of action, including low-molecular weight radiopharmaceuticals, peptides and proteins, siRNA, cells, and nanoparticles Applications of imaging techniques in administration routes other than intravenous injection, such as pulmonary and oral delivery Translational research leading to clinical applications Imaging drug delivery in large animal models Clinical applications of imaging techniques to guide drug development and drug delivery Chapters are based on a thorough review of the current literature as well as the authors' firsthand experience working with imaging techniques for the development of novel drug delivery systems. Presenting state-of-the-technology applications of imaging in preclinical and clinical evaluation of drug delivery systems, Drug Delivery Applications of Noninvasive Imaging offers cost-effective strategies to pharmaceutical researchers and students for developing drug delivery systems that accurately target a broad range of disease conditions.
Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.
Steroid dimers are an important group of compounds produced by various marine organisms, and also synthesized in the laboratories. This group of compounds possesses various pharmacological and biological properties, and can also be used to create “molecular umbrellas” for drug delivery. Steroid Dimers: Chemistry and Applications in Drug Design and Delivery provides an up-to-date overview on the chemistry and applications of steroid dimers of natural and synthetic origins. The book includes easy-to-follow synthetic protocols for various classes of important dimeric steroids, source details, valuable spectroscopic data and depiction of unique structural features of natural steroidal dimers, and the Structure-Activity-Relationships (SARs) of some pharmacologically active dimeric steroids. Topics covered include: introduction to steroid dimers synthesis and chemistry of noncyclic and cyclic steroid dimers naturally occurring steroid dimers – cephalostatins, ritterazines and crellastatins biological and pharmacological functions of steroid dimers and their application in drug design and discovery steroid dimers as “molecular umbrellas” for drug delivery Steroid Dimers: Chemistry and Applications in Drug Design and Delivery is an essential guide to this important class of natural and synthetic compounds for researchers and students of natural products chemistry and biochemistry, synthetic organic and medicinal chemistry, and drug design, discovery and delivery.
Now covering both conventional and unmanned systems, this is a significant update of the definitive book on aircraft system design Design and Development of Aircraft Systems, Second Edition is for people who want to understand how industry develops the customer requirement into a fully integrated, tested, and qualified product that is safe to fly and fit for purpose. This edition has been updated to take into account the growth of unmanned air vehicles, together with updates to all chapters to bring them in line with current design practice and technologies as taught on courses at BAE Systems and Cranfield, Bristol and Loughborough universities in the UK. Design and Development of Aircraft Systems, Second Edition Provides a holistic view of aircraft system design describing the interaction between all of the subsystems such as fuel system, navigation, flight control etc. Covers all aspects of design including systems engineering, design drivers, systems architectures, systems integration, modelling of systems, practical considerations, & systems examples. Incorporates essential new material on Unmanned Aircraft Systems (UAS). Design and Development of Aircraft Systems, Second Edition has been written to be generic and not to describe any single process. It aims to complement other volumes in the Wiley Aerospace Series, in particular Aircraft Systems, Third Edition and Civil Avionics Systems by the same authors, and will inform readers of the work that is carried out by engineers in the aerospace industry to produce innovative and challenging – yet safe and reliable – systems and aircraft. Essential reading for Aerospace Engineers.
An authoritative look at the application of chemical biology in drug discovery and development Based on the award-winning Wiley Encyclopedia of Chemical Biology published in 2008, this book explores the role of chemical biology in drug discovery and development. The first part of the book reviews key principles and techniques used in the design and evaluation of drug candidates. The second part elucidates biological mechanisms of certain diseases, illuminating approaches to investigate and target these diseases. Comprising carefully selected reprints from the Encyclopedia as well as new contributions from leading scholars in the field, this book provides researchers in academia and industry with important information to aid in the development of novel agents to treat disease. Self-contained articles cover a variety of essential topics, including: The design, development, and optimization of drug candidates The pharmacokinetics and properties of drugs Drug transport and delivery Natural products and natural product models as pharmaceuticals Biological mechanisms underlying health and disease Treatment strategies for a range of diseases, from HIV to schizophrenia Chemical Biology is a top-notch guide and reference for anyone working in the areas of drug discovery and development, including researchers in chemical biology and other fields such as biochemistry, medicine, and pharmaceutical sciences.
The use of computers has opened up remarkable opportunities for innovative design, improved productivity, and greater efficiency in the use of materials. Uniquely, this book focuses on the practical use of computers for clothing pattern design and product development. Readers are introduced to the various computer systems which are suitable for the industry, the principles and techniques of pattern design applied to computer systems are explained, and readers are shown how product data management can be used in clothing product development.
Solar Energy is an authoritative reference on the design of solar energy systems in building projects, with applications, operating principles, and simple tools for the construction, engineering, and design professional. The book simplifies the solar design and engineering process, providing sample documentation and special tools that provide all the information needed for the complete design of a solar energy system for buildings to enable mainstream MEP and design firms, and not just solar energy specialists, to meet the growing demand for solar energy systems in building projects.
Chitosan is a linear polysaccharide commercially produced by the deacetylation of chitin. It is non-toxic, biodegradable, biocompatible, and acts as a bioadhesive with otherwise unstable biomolecules – making it a valuable component in the formulation of biopharmaceutical drugs. Chitosan-Based Systems for Biopharmaceuticals provides an extensive overview of the application of chitosan and its derivatives in the development and optimisation of biopharmaceuticals. The book is divided in four different parts. Part I discusses general aspects of chitosan and its derivatives, with particular emphasis on issues related to the development of biopharmaceutical chitosan-based systems. Part II deals with the use of chitosan and derivatives in the formulation and delivery of biopharmaceuticals, and focuses on the synergistic effects between chitosan and this particular subset of pharmaceuticals. Part III discusses specific applications of chitosan and its derivatives for biopharmaceutical use. Finally, Part IV presents diverse viewpoints on different issues such as regulatory, manufacturing and toxicological requirements of chitosan and its derivatives related to the development of biopharmaceutical products, as well as their patent status, and clinical application and potential. Topics covered include: chemical and technological advances in chitins and chitosans useful for the formulation of biopharmaceuticals physical properties of chitosan and derivatives in sol and gel states absorption promotion properties of chitosan and derivatives biocompatibility and biodegradation of chitosan and derivatives biological and pharmacological activity of chitosan and derivatives biological, chemical and physical compatibility of chitosan and biopharmaceuticals approaches for functional modification or crosslinking of chitosan use of chitosan and derivatives in conventional biopharmaceutical dosage forms manufacture techniques of chitosan-based microparticles and nanoparticles for biopharmaceuticals chitosan and derivatives for biopharmaceutical use: mucoadhesive properties chitosan-based systems for mucosal delivery of biopharmaceuticals chitosan-based delivery systems for mucosal vaccination chitosan-based nanoparticulates for oral delivery of biopharmaceuticals chitosan-based systems for ocular delivery of biopharmaceuticals chemical modification of chitosan for delivery of DNA and siRNA target-specific chitosan-based nanoparticle systems for nucleic acid delivery functional PEGylated chitosan systems for biopharmaceuticals stimuli-sensitive chitosan-based systems for biopharmaceuticals chitosan copolymers for biopharmaceuticals application of chitosan for anti-cancer biopharmaceutical delivery chitosan-based biopharmaceuticals scaffolds in tissue engineering and regenerative medicine wound healing properties of chitosan and its use in wound dressing biopharmaceuticals toxicological properties of chitosan and derivatives for biopharmaceutical applications regulatory status of chitosan and derivatives patentability and intellectual property issues quality control and good manufacturing practice preclinical and clinical use of chitosan and derivatives for biopharmaceuticals Chitosan-Based Systems for Biopharmaceuticals is an important compendium of fundamental concepts, practical tools and applications of chitosan-based biopharmaceuticals for researchers in academia and industry working in drug formulation and delivery, biopharmaceuticals, medicinal chemistry, pharmacy, bioengineering and new materials development.
Design management as a recognised role in the built environment industry is relatively new, initially arising from the need for better co-ordination and delivery of design information from design teams to main contractors – particularly important as procurement routes involving contractor led design have become much more commonplace. The advent of design packages driven by specialist sub-contractors has also increased the need for co-ordination and management of the design process. With the growing complexity of construction projects, effective design management is increasingly central to project success. BIM, as it gains acceptance across the industry will undoubtedly have a huge impact on project delivery process and the role of the Design Manager. The CIOB Design Manager’s Handbook covers subjects such as design process and management tools, the role of the Design Manager, value management and innovation, procurement routes and implications, people dynamics, and factors that will affect the development of the Design Manager’s role in the future, including BIM. It will ensure Design Managers understand the processes, tools and skills that are required to be successful in the role, and will assist them in delivering real value to complex construction projects. Written for both the Design Manager practitioner and students on construction related degree courses, anyone interested in construction based design management will also find the book useful.
RNA Interference: Application to Drug Discovery and Challenges to Pharmaceutical Development provides a general overview of this rapidly emerging field, with a strong emphasis on issues and aspects that are important to a drug development team. The first part covers more general background of RNA interference and its application in drug discovery. In the second part, the book addresses siRNA (small interfering RNA), a pharmaceutically potent form, and its use and delivery in therapeutics along with manufacturing and delivery aspects.
Understand and assess the design, delivery, and efficacy of orally administered drugs A practical guide to understanding oral bioavailability, one of the major hurdles in drug development and delivery, Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications is designed to help chemists, biologists, life science researchers, pharmaceutical scientists, pharmacologists, clinicians, and graduate and students become familiar with the fundamentals and practices of the science of oral bioavailability. The difference in rate and extent between a drug taken orally and the actual amount of a drug reaching the circulatory system, oral bioavailability is an essential parameter for determining the efficacy and adverse effects of new and developing medications, as well as finding an optimal dosing regimen. This book provides a much-needed one-stop resource to help readers better understand and appreciate the many facets and complex problems of oral bioavailability, including the basic barriers to oral bioavailability, the methods used to determine relevant parameters, and the challenges of drug delivery. In addition, this comprehensive book discusses biological and physicochemical methods for improving bioavailability, integrates physicochemistry with physiology and molecular biology, and includes several state-of-the-art technologies and approaches—Caco-2 cell culture model, MDCK, and other related cell culture models—which are used to study the science of oral bioavailability.
“… a must-read for all modern bio-scientists and engineers working in the field of biotechnology.” – Biotechnology Journal, 2012, 7 A cutting-edge guide on the fundamentals, theory, and applications of biomechatronic design principles Biomechatronic Design in Biotechnology presents a complete methodology of biomechatronics, an emerging variant of the mechatronics field that marries biology, electronics, and mechanics to create products where biological and biochemical, technical, human, management-and-goal, and information systems are combined and integrated in order to solve a mission that fulfills a human need. A biomechatronic product includes a biological, mechanical, and electronic part. Beginning with an overview of the fundamentals and theory behind biomechatronic technology, this book describes how general engineering design science theory can be applied when designing a technical system where biological species or components are integrated. Some research methods explored include schemes and matrices for analyzing the functionality of the designed products, ranking methods for screening and scoring the best design solutions, and structuring graphical tools for a thorough investigation of the subsystems and sub-functions of products. This insightful guide also: Discusses tools for creating shorter development times, thereby reducing the need for prototype testing and verification Presents case study-like examples of the technology used such as a surface plasmon resonance sensor and a robotic cell culturing system for human embryonic stem cells Provides an interdisciplinary and unifying approach of the many fields of engineering and biotechnology used in biomechatronic design By combining designs between traditional electronic and mechanical subsystems and biological systems, this book demonstrates how biotechnology and bioengineering design can utilize and benefit from commonly used design tools— and benefit humanity itself.
Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of «what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?» and «when do the various required activities need to be performed?» Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code