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The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market.
This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious.
"This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)... this book could not be more timely. "
"Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript) "
Volume V of this manual provides an overview of the analytical investigation of numerous additional Chinese herbal drugs that are commonly used in Traditional Chinese Medicine (TCM). It illustrates the detailed chromatographic analysis of the main compounds with colored TLC photographs and HPLC peak profiles, and also discusses the bioactive properties, pharmacological and biological activity as well as the therapeutic applications of all single herbal drugs. Together with Volumes I-IV this volume represents the most comprehensive overview of analytical studies of these drugs listed in the Chinese Pharmacopoeia 2010. All the experimental requirements, including the extraction procedure for the Chinese drugs and the solvent systems used for the development of the TLC and HPLC analytical monographs, were adapted according to the latest findings published in international journals and the high standards of the European Drug Regulatory Authority. Therefore Volume V is also a must-have manual for researchers and pharmaceutical laboratories dedicated to TCM.
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 analysisImaging drugs and drug carriers at the site of action, including low-molecular weight radiopharmaceuticals, peptides and proteins, siRNA, cells, and nanoparticlesApplications of imaging techniques in administration routes other than intravenous injection, such as pulmonary and oral deliveryTranslational research leading to clinical applicationsImaging drug delivery in large animal modelsClinical 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.
This volume gives an overview of state of the art technologies and future developments in the field of preclinical pharmaceutical research. A balanced mix of experts from academia and industry give insight in selected new developments in the drug discovery pathway. The topics cover the different parts of the drug discovery process, starting with new developments in the target identification and validation area. The lead generation part as a next step focuses on the requirements and technologies to identify new small molecules as lead compounds for further optimization; in a second section the technologies to identify biologics as leads are addressed. The final part focuses on the pharmacological models and technologies to characterize new compounds and the impact of biomarkers to facilitate the transfer of drug candidates into the development phase.
"Quality Systems and Control for Pharmaceuticals" is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.
Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.
The author has both industry and academic experience and many 'best practice' examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.
This book reviews a number of issues including: Why data generated from POC machines are considered as Big Data. What are the challenges in storing, managing, extracting knowledge from data from POC devices? Why is it inefficient to use traditional data analysis with big data? What are the solutions for the mentioned issues and challenges? What type of analytics skills are required in health care? What big data technologies and tools can be used efficiently with data generated from POC devices? This book shows how it is feasible to store vast numbers of anonymous data and ask highly specific questions that can be performed in real-time to give precise and meaningful evidence to guide public health policy.
With a focus on case studies of R&D programs in a variety of disease areas, the book highlights fundamental productivity issues the pharmaceutical industry has been facing and explores potential ways of improving research effectiveness and efficiency. Takes a comprehensive and holistic approach to the problems and potential solutions to drug compound attrition Tackles a problem that adds billions of dollars to drug development programs and health care costs Guides discovery and development scientists through R&D stages, teaching requirements and reasons why drugs can fail Discusses potential ways forward utilizing new approaches and opportunities to reduce attrition
This book describes how microbes can be used as effective and sustainable resources to meet the current challenge of finding suitable and economical solutions for biopharmaceuticals, enzymes, food additives, nutraceuticals, value added biochemicals and microbial fuels, and discusses various aspects of microbial regulatory activity and its applications. It particularly focuses on the design, layout and other relevant issues in industrial microbe applications. Moreover, it discusses the entire microbial-product supply chain, from manufacturing sites to end users, both in domestic and international markets, providing insights into the global marketing of microbes and microbial biomass-derived products. Further, it includes topics concerning the effective production and utilization of eco-friendly biotechnology industries. It offers a valuable, ready-to-use guide for technologists and policymakers developing new biotechnologies.
A guide to all aspects of tablet and capsule machine instrumentation in pharmaceutical research, development and production.In order to produce a satisfactory tablet or capsule it is necessary to combine a sound formulation with a proper control of the tabletting or capsule filling process. These considerations involve the need to make accurate measurements and this text provides a practical guide to the techniques and applications of instrumentation used to make these measurements.This text provides a sound understanding of the principles and techniques involved, and of how data generated by instrumented machines can be applied to problems in pharmaceutical research, development and manufacture.It encompasses major advances in instrumentation methodology as well as in both tablet presses and capsule filling equipment. In particular there are new methods of measurement, the feeding of the output of instrumentation into computers has become routine, and instrumentation techniques have been expanded to tablet press simulators, automatic press control and capsule filling equipment.
Multi-component crystalline systems or co-crystals have received tremendous attention from academia and industry alike in the past decade. Applications of co-crystals are varied and are likely to positively impact a wide range of industries dealing with molecular solids. Co-crystallization has been used to improve the properties and performance of materials from pharmaceuticals to energetic materials, as well as for separation of compounds. This book combines co-crystal applications of commercial and practical interest from diverse fields in to a single volume. It also examines effective structural design of co-crystals, and provides insights into practical synthesis and characterization techniques. Providing a useful resource for postgraduate students new to applied co-crystal research and crystal engineering, it will also be of interest to established researchers in academia or industry.
'What gets measured gets fixed' and this is as true of the pharmaceutical industry as any other. The problem is that pharmaceutical businesses are complex. Drug research and development involves extended and expensive processes; defining appropriate metrics for these processes is not easy, yet ineffective or misguided metrics can be more damaging than none at all. David Zuckerman's Pharmaceutical Metrics is an extremely practical guide to selecting a system, selling it to top management, choosing and defining the right metrics for your system, communicating and displaying the results. And because metrics are about how to shape and develop your business, he explores how to deploy them organization-wide and make sure that they are driving business improvement. In order to reflect the needs of different types of pharmaceutical company the author uses four sample companies, throughout the book, to illustrate the principles for 'big pharma', 'micro pharma', a virtual development company and a CRO. This highly practical book provides a step-by-step guide to creating a state-of-the-art, strategy-driven metrics system for pharmaceutical R&D, supported by case studies of the techniques applied and tips for optimizing the system.
Liposomes have been widely explored in the drug delivery realm over the past decades. Many of the properties that made them well suited for drug delivery applications, such as the internal space to encapsulate a large payload of molecules and the inherent protection from exterior stresses, have also been exploited in various analytical techniques. Liposomes in Analytical Methodologies provides an extensive coverage of their utility, ranging from historic developments to actively researched techniques written by expert investigators. The introductory chapter serves as a primer on the fundamentals of liposomes for analytical purposes and provides an overview of various applications, while subsequent chapters provide in-depth coverage of selected areas. With techniques ranging from liposome PCR to electrophoretic separations, readers will gain an appreciation for the versatility that liposomes can add to the analytical toolbox.
The first contribution reviews the occurrence of xanthine alkaloids in the plant kingdom and the elucidation of the caffeine biosynthesis pathway, providing details of the N-methyltransferases, belonging to the motif B' methyltransferase family which catalyze three steps in the four step pathway leading from xanthosine to caffeine. The second contribution in this book provides a background on the molecule and related compounds and update knowledge on the most recent advances in Iboga alkaloids. The third contribution presents a comprehensive analysis of frequently occurring errors with respect to 13C NMR spectroscopic data and proposes a straightforward protocol to eliminate a high percentage of the most obvious errors.
The first contribution describes apolar and polar molecular fossils and, in particular biomarkers, along the lines usually followed in organic chemistry textbooks, and points to their bioprecursors when available. Thus, the apolar compounds are divided in linear and branched alkanes followed by alicyclic compounds and aromatic and heterocyclic molecules, and, in particular, the geoporphyrins. The polar molecular fossils contain as functional groups or constituent units ethers, alcohols, phenols, carbonyl groups, flavonoids, quinones, and acids, or are polymers like kerogen, amber, melanin, proteins, or nucleic acids. The final sections discuss the methodology used and the fundamental processes encountered by the biomolecules described, including diagenesis, catagenesis, and metagenesis. The second contribution covers the distribution of phthalides in nature and the findings in the structural diversity, chemical reactivity, biotransformations, syntheses, and bioactivity of natural and semisynthetic phthalides.
Pharmaceutical Isolators is a new indispensable guide to the design, construction, commissioning, maintenance, use and monitoring of pharmaceutical isolators. The current validation protocols are explained and the book includes some useful technical appendices. Written through the combined technical expertise of the Isolator Working Party, this new title will assist both experienced and new users to understand and manage this technology. The book will also be a useful reference source for auditors, inspectors and all those involved in standard setting and monitoring.
The author has summarized a decade of teaching combinatorial chemistry into this timely brief. The solid phase synthesis of unnatural heterocyclic alpha-amino acids is illustrated by practical examples starting from the ABCs of peptide synthesis explored in chapter one. Chapter two is concerned with the solid phase synthesis which is shown on various techniques - BillBoard, tea-bag, and Lantern devices, and demonstrated on heterocyclic examples and protocols. In the third chapter the tools for accelerating chemical synthesis - solid phase and liquid phase - are reviewed. Here the techniques of parallel refluxing (including microwave and flow technique) and parallel separation (filtration, centrifugation, evaporation, and chromatography) are described. In the chapters 4 and 5 the author goes on to describe how the liquid phase synthesis of heterocycles (reductive amination and Ugi reaction of heterocycles) is illustrated with the use of semi-automated protocols. Finally, the design of combinatorial libraries of heterocycles is reviewed including the original author's findings.
This dictionary defines various terms typically used in pharmaceutical medicine. A new, 4th edition includes adaptations of the text to the steadily increasing regulatory requirements, particularly in the area of genetics/gene therapy, product quality (e.g., protection against falsified medicines) and of product safety (pharmacovigilance). Further evolving areas that are covered by the 4th edition are typical "grey zones" (health effects often borderline to medicinal products) such as cosmetics and dietary supplements where misleading information is prohibited on one hand but where any health claims need formal authorisation on the other. These but also other areas are reviewed and presented in an updated and - if justified - in an enlarged form.
This reference work gives a compete overview of the different stages of drug development using a translational approach. The book is structured in different parts, following the different stages in drug development. Almost half of the work is dedicated to core of drug discovery using a translational approach, the identification of appropriate targets and screening methods for the identification of compounds interacting with these targets. The rest of book covers the whole downstream pipeline after the identification of lead compounds, such as bioavailability issues, identification of appropriate drug delivery venues, production and scaling issues and preclinical trials. As has been the case with other works in the encyclopedia, the book is made up of long, comprehensive and authoritative chapters, written by outstanding researchers in the field.
The embedding of any new technologies in society is challenging. The evolving state of the scientific art, often-unquantifiable risks and ill-defined developmental trajectories have the potential to hinder innovation and/or the commercial success of a technology. The are, however, a number of tools that can now be utilized by stakeholders to bridge the chasm that exists between the science and innovation dimensions on the one hand, and the societal dimensions on the other. This edited volume will draw together leading researchers from the domains of law, philosophy, political science, public administration and the natural sciences in order to demonstrate how tools such as, for example, constructive technology assessment, regulatory governance and societal scenarios, may be employed by stakeholders to assist in successfully embedding new technologies into society. This volume will focus primarily on the embedding of two emergent and emerging technologies: nanotechnologies and synthetic biology. Government, industry and the epistemic community continue to struggle with how best to balance the promised benefits of an emerging technology with concerns about its potential impacts. There is a growing body of literature that has examined these challenges from various cultural, scientific and jurisdictional dimensions. There is, however, much work that still needs to be done; this includes articulating the successes and failures of attempts to the societal embedding of technologies and their associated products. This edited volume is significant and timely, as unlike other books currently on the market, it shall draw from real work experiences and experiments designed anticipate the societal embedding of emerging technologies. This empirical work shall be supported by robust theoretical underpinnings.
Natural Products and Drug Discovery: An Integrated Approach provides an applied overview of the field, from traditional medicinal targets, to cutting-edge molecular techniques. Natural products have always been of key importance to drug discovery, but as modern techniques and technologies have allowed researchers to identify, isolate, extract and synthesize their active compounds in new ways, they are once again coming to the forefront of drug discovery. Combining the potential of traditional medicine with the refinement of modern chemical technology, the use of natural products as the basis for drugs can help in the development of more environmentally sound, economical, and effective drug discovery processes. Natural Products & Drug Discovery: An Integrated Approach reflects on the current changes in this field, giving context to the current shift and using supportive case studies to highlight the challenges and successes faced by researchers in integrating traditional medicinal sources with modern chemical technologies. It therefore acts as a useful reference to medicinal chemists, phytochemists, biochemists, pharma R&D professionals, and drug discovery students and researchers.
Understanding and quantifying the effects of membrane transporters within the human body is essential for modulating drug safety and drug efficacy. This two volume set of books comprehensively reviews current knowledge and techniques in the transporter sciences and their relations to drug metabolism and pharmacokinetics. The second volume is specifically dedicated to emerging science and technologies, highlighting potential areas for future advances within the drug transporter field. The topics covered in this set of books ensure that all relevant aspects of transporters are described across the drug development process, from in silico models and preclinical tools through to the potential impact of transporters in the clinic. Contributions are included from expert leaders in the field, at-the-bench industrial scientists, renowned academics and international regulators. Case studies and emerging developments are highlighted, together with the merits and limitations of the available methods and tools, and extensive references to reviews on specific in-depth topics are also included for those wishing to pursue their knowledge further. As such, this text serves as an essential handbook of information for postgraduate students, academics, industrial scientists and regulators who wish to understand the role of transporters in absorption, distribution, metabolism, and excretion processes. In addition, it is also a useful reference tool on the models and calculations necessary to predict their effect on human pharmacokinetics and pharmacodynamics.
This volume of Modern Aspects of Electrochemistry reviews the latest developments in electrochemical science and technology related to biomedical and pharmaceutical applications. In particular, this book discusses electrochemical applications to medical devices, implants, antimicrobially active materials, and drug delivery systems.
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