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The only reference on current methods to generate pharmacokinetic
and safety profiles of drug candidates, as well as how they must be
balanced against one other for the best selection of candidates for
In light of the rapidity increasing incidence rate of bacterial and fungal infections with multi-resistant pathogens, the metabolic changes associated with host-pathogen interactions offer one of the most promising starting points for developing novel antibiotics. . Part one of this comprehensive guide describes the metabolic adaptation of pathogenic microbes in humans, while part two points to routes for the development of novel antibiotics. This is volume six of the book series on drug discovery in infectious diseases by Paul Selzer.
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 dimersnaturally occurring steroid dimers - cephalostatins, ritterazines and crellastatinsbiological and pharmacological functions of steroid dimers and their application in drug design and discoverysteroid 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.
With its focus on emerging concerns of kinase and GPCR-mediated antitarget effects, this vital reference for drug developers addresses one of the hot topics in drug safety now and in future. Divided into three major parts, the first section deals with novel technologies and includes the utility of adverse event reports to drug discovery, the translational aspects of preclinical safety findings, broader computational prediction of drug side-effects, and a description of the serotonergic system. The main part of the book looks at some of the most common antitarget-mediated side effects, focusing on hepatotoxicity in drug safety, cardiovascular toxicity and signaling effects via kinase and GPCR anti-targets. In the final section, several case studies of recently developed drugs illustrate how to prevent anti-target effects and how big pharma deals with them if they occur. The more recent field of systems pharmacology has gained prominence and this is reflected in chapters dedicated to the utility in deciphering and modeling anti-targets. The final chapter is concerned with those compounds that inadvertently elicit CNS mediated adverse events, including a pragmatic description of ways to mitigate these types of safety risks. Written as a companion to the successful book on antitargets by Vaz and Klabunde, this new volume focuses on recent progress and new classes, methods and case studies that were not previously covered.
This book is the 4th in a series of Acute Care books written with the aim to address the NEEDS of health care providers when handling the acutely ill patients. Globally it has become apparent that the study of pharmacology and subsequent clinical training has not always adequately equipped young doctors with the ability to administer drugs to their patients safely and confidently, particularly in the critically ill patient. Compounding this issue is the lack of resource material related to these pharmacological concepts contained in one book that can help health care providers to understand and manage drug therapy in the acute situation. In spite of progressively newer and more developed protocols, guidelines, algorithms and many other books addressing the technical aspects of what needs to be done, most health care providers still find it difficult to grasp the basic pharmacological knowledge and rationally deliver the CARE that is required in the acute phase of patient management. The editors/authors have therefore aimed for a book that highlights topics and pharmacological issues pertinent to management of patients in their hour of need. This is a multi-author book but the style has been guided by 3 editors. The editors have used a different perspective - that of normalizing abnormal physiological processes with pharmacological agents - to address the GAPS in a bedside to bench approach. The details are pared down but important principles/concepts are emphasized.
This collection of high-profile contributions provides a unique insight into the development of novel, successful biopharmaceuticals.
Outstanding authors, including Nobel laureate Robert Huber as well as prominent company researchers and CEOs, present valuable insider knowledge, limiting their scope to those procedures and developments with proven potential for the biotechnology industry. They cover all relevant aspects, from the establishment of biotechnology parks, the development of successful compounds and the implementation of efficient manufacturing processes, right up to the establishment of advanced delivery routes.
Mucoadhesion defined as attachment of synthetic or natural materials to mucosal tissues has been widely exploited in pharmaceutical forms. This multi-author book provides an up-to-date account of current research on mucoadhesive materials and drug delivery systems. The introductory section describes the structure and physiology of various mucosal surfaces (oral, nasal, ocular, gastrointestinal and vaginal mucosa). This is followed by chapters on the various methods used to study mucoadhesion and to characterise mucoadhesive properties of various dosage forms. The final section will summarise information on traditional and novel types of mucoadhesive materials, such as chitosan, thiomers, and liposome-based formulations. This book is unique as there is currently no modern book considering mucoadhesion - all other existing books on the topic are either narrowly focused or more than 10 years old. Furthermore, each contributor offers specialist perspectives from a variety of global locations in both industrial and academic research centres.
The gold standard for industrial research now completely revised in
line with current trends in the field, with all contributions
extensively updated or rewritten.
This one-stop reference is the first to present the complete
picture -- covering all relevant organisms, from single cells to
mammals, as well as all major disease areas, including neurological
disorders, cancer and infectious diseases.
By covering the full spectrum of topics relevant to peptidic drugs,
this timely handbook serves as an introductory reference for both
drug developers and biomedical researchers interested in
pharmaceutically active peptides, presenting both the advantages
and challenges associated with this molecular class.
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
Innovative and forward-looking, this volume focuses on recent achievements in this rapidly progressing field and looks at future potential for development. The first part provides a basic understanding of the factors governing protein-ligand interactions, followed by a comparison of key experimental methods (calorimetry, surface plasmon resonance, NMR) used in generating interaction data. The second half of the book is devoted to insilico methods of modeling and predicting molecular recognition and binding, ranging from first principles-based to approximate ones. Here, as elsewhere in the book, emphasis is placed on novel approaches and recent improvements to established methods. The final part looks at unresolved challenges, and the strategies to address them. With the content relevant for all drug classes and therapeutic fields, this is an inspiring and often-consulted guide to the complexity of protein-ligand interaction modeling and analysis for both novices and experts.
Most drugs are analogue drugs. There are no general rules how a new
drug can be discovered, nevertheless, there are some observations
which help to find a new drug, and also an individual story of a
drug discovery can initiate and help new discoveries. Volume III is
a continuation of the successful book series with new examples of
established and recently introduced drugs.
Edited by three of the world's leading pharmaceutical scientists, this is the first book on this important and hot topic, containing much previously unpublished information. As such, it covers all aspects of green chemistry in the pharmaceutical industry, from simple molecules to complex proteins, and from drug discovery to the fate of pharmaceuticals in the environment. Furthermore, this ready reference contains several convincing case studies from industry, such as Taxol, Pregabalin and Crestor, illustrating how this multidisciplinary approach has yielded efficient and environmentally-friendly processes. Finally, a section on technology and tools highlights the advantages of green chemistry.
Applied Biophysics for Drug Discovery is a guide to new techniques and approaches to identifying and characterizing small molecules in early drug discovery. Biophysical methods are reasserting their utility in drug discovery and through a combination of the rise of fragment-based drug discovery and an increased focus on more nuanced characterisation of small molecule binding, these methods are playing an increasing role in discovery campaigns. This text emphasizes practical considerations for selecting and deploying core biophysical method, including but not limited to ITC, SPR, and both ligand-detected and protein-detected NMR. Topics covered include: Design considerations in biophysical-based lead screening Thermodynamic characterization of protein-compound interactions Characterizing targets and screening reagents with HDX-MS Microscale thermophoresis methods (MST) Screening with Weak Affinity Chromatography Methods to assess compound residence time 1D-NMR methods for hit identification Protein-based NMR methods for SAR development Industry case studies integrating multiple biophysical methods This text is ideal for academic investigators and industry scientists planning hit characterization campaigns or designing and optimizing screening strategies.
"Pharmaceutical Emulsions: A Drug Developer's Toolbag" covers all the key aspects of pharmaceutical emulsions, starting from the fundamental scientific basics, to the pharmaceutical forms and the chemical tests for its application. The author uses his extensive experience in both industry and academic experience to provide a concise, student friendly guide to the essential fundamentals of physical pharmacy.
Divided into three clear sections, the text begins with Section A - "Consideration for Product: Medicinal Formulation" which includes a historical perspective, explanation of what is an emulsion, stability and instability, and manufacture. Section B - "Forms, Use and Application" follows, with chapters on creams and ointments, pastes and bases, colloids, transdermal, gels and implants. The final Section, "Tests: Chemistry to control the quality," efficacy and fitness for purpose of the product includes chapters on physic-chemical properties, sizing and microscopy, rheology, QC and finally questions, calculations and dilemmas. Throughout the text there are numerous figures, diagrams and tables to engage the reader.
This is an invaluable reference for all students of pharmaceutical sciences, pharmacy industrial pharmaceutical sciences, physical pharmacy and pharmaceutical forms as well as industry professionals
Site-specific drug delivery and targeting is attracting much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Bringing together leading field experts, Targeted Delivery of Small and Macromolecular Drugs summarizes current progress with a focus on the novel ideas being explored to overcome these challenges.
Focuses on the Targeted Drug Delivery Technologies that
? Active targeting
Targeted Delivery of Small and Macromolecular Drugs demonstrates why targeted delivery is one of the most exciting contributions pharmaceutical sciences can make to drug therapy.
The pharmaceutical industry has become acutely aware of the importance of the solid state, but pharmaceutical scientists often lack specific training in topics related to solid-state structure and crystallography. This book provides needed support in this topical area. Taking an intuitive and informal approach to solid-state structure and crystallographic concepts, this book is written for anyone who needs a clear understanding of modern crystallography, with specific reference to small-molecule pharmaceutical solids. The author describes molecular crystals and crystal structures, symmetry, space groups, single-crystal and powder X-ray diffraction techniques and the analysis and interpretation of crystallographic data. Useful technical details are presented where necessary and case studies from the pharmaceutical literature put theory into a practical context. Written by an internationally leading figure abd with its focus on molecular crystals, this book is equally applicable to anyone studying or working in solid-state chemistry and structure determination.
"...a useful addition to the bookshelf of every natural material specialist..." -Pharmazie in unserer Zeit, 2010 (review in German) Organized in a classical alphabetical format, this two-volume reference covers 1000 carefully screened natural product structures. For each compound or compund class, a basic chemical characterization is given, followed by a description of the biological source and a discussion of their pharmaceutical potential as lead molecules for new drugs. The letter takes into account the documented uses of many of these compounds in Asian traditional medicine. By way of its clearly structured articles, and with the aid of classification tables in the appendix, this dictionary is easy to use and provides quick and reliable information for researchers as well for scholars and student. Compounds have been selected from the following chemical classes: - Alkaloids - Phenolics - Antibiotics - Polyketides - Carbohydrates - Proteins - Chalcones - Steroids - Coumarins - Terpenoids - Flavonoids - Xanthonoids - Peptides
'Cannabinoids' is a broad term covering a group of natural products from Cannabis sativa, one of which locks on to specific receptors - protein molecules on the surface of cells - known as cannabinoid receptors. Over the past decades scientists have found that cannabinoid receptors and their endogenous ligands, the endocannabinoids, are involved in a vast array of physiological functions, including helping to control brain activity, energy metabolism, heart function, the immune system and even reproduction. In Cannabinoids, Vincenzo Di Marzo has assembled contributions from international experts to provide the definitive guide to what continues to be a rapidly developing research field. After an introductory historical chapter, the book continues by looking at the biochemical, genetic and molecular elements of cannabinoids, followed by chapters covering their role in health and disease. The final chapter outlines the need for a new nomenclature to reflect the complex and multi-disciplinary nature of this area.
Pharmaceutical manufacturing was one of the first industries to recognize the importance of green chemistry, with pioneering work including green chemistry metrics and alternative solvents and reagents. Today, other topical factors also have to be taken into consideration, such as rapidly depleting resources, high energy costs and new legislation. This book addresses current challenges in modern green chemical technologies and sustainability thinking. It encompasses a broad range of topics covered by the CHEM21 project - Europe's largest public-private partnership project which aims to develop a toolbox of sustainable technologies for green chemical intermediate manufacture. Divided into two sections, the book first gives an overview of the key green chemistry tools, guidance and considerations aimed at developing greener processes, before moving on to look at cutting-edge synthetic methodologies. Featuring innovative research, this book is an invaluable reference for chemists across academia and industry wanting to further their knowledge and understanding of this important topic.
Covering the whole area of process chemistry in the pharmaceutical
industry, this monograph provides the essential knowledge on the
basic chemistry needed for future development and key industrial
techniques, as well as morphology, engineering and regulatory
Antibacterial agents act against bacterial infection either by killing the bacterium or by arresting its growth. They do this by targeting bacterial DNA and its associated processes, attacking bacterial metabolic processes including protein synthesis, or interfering with bacterial cell wall synthesis and function."Antibacterial Agents" is an essential guide to this important class of chemotherapeutic drugs. Compounds are organised according to their target, which helps the reader understand the mechanism of action of these drugs and how resistance can arise. The book uses an integrated "lab-to-clinic" approach which covers drug discovery, source or synthesis, mode of action, mechanisms of resistance, clinical aspects (including links to current guidelines, significant drug interactions, cautions and contraindications), prodrugs and future improvements.Agents covered include: agents targeting DNA - quinolone, rifamycin, and nitroimidazole antibacterial agentsagents targeting metabolic processes - sulfonamide antibacterial agents and trimethoprimagents targeting protein synthesis - aminoglycoside, macrolide and tetracycline antibiotics, chloramphenicol, and oxazolidinonesagents targeting cell wall synthesis - β-Lactam and glycopeptide antibiotics, cycloserine, isonaizid, and daptomycin
"Antibacterial Agents" will find a place on the bookshelves of students of pharmacy, pharmacology, pharmaceutical sciences, drug design/discovery, and medicinal chemistry, and as a bench reference for pharmacists and pharmaceutical researchers in academia and industry.
Medicines play an important role in the treatment and prevention of disease in humans and animals, but residues from these medicines can be released into the environment through a number of routes during their manufacture, use and disposal. It is only recently that the potential environmental impacts of this exposure to pharmaceuticals are being considered. The book explores where pharmaceutical residues can be found, e.g. in surface waters, drinking water, sediments and the marine environment; the sources of these residues, from manufacture through to disposal of unused medicines; how these residues break down; and how this all impacts on wildlife and human health. In reviewing the current position and examining further possible impacts, this book is an important reference for researchers working in the pharmaceutical industry, as well as for environmentalists, policy makers and students on pharmacy and environmental science courses wanting to better understand the impacts of pharmaceuticals on the environment.
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. "Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations "provides a practical description of nonclinical drug development regulations and requirements in the major market regions.
It includes: ICH - the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseNational regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and AustraliaRepeated dose toxicity studiesCarcinogenicity; Genotoxicity; Developmental and reproductive toxicology; ImmunotoxicologyBiotechnology-derived pharmaceuticalsVaccine developmentPhototoxicity and photocarcinogenicityDegradants, impurities, excipients and metabolites
Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.""
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