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This consolidated reference book addresses the various aspects of nano biomaterials used in ophthalmic drug delivery, including their characterization, interactions with ophthalmic system and applications in treatments of the ophthalmic diseases and disorders. In the last decade, a significant growth in polymer sciences, nanotechnology and biotechnology has resulted in the development of new nano- and bioengineered nano-bio-materials. These are extensively explored as drug delivery carriers as well as for implantable devices and scaffolds. At the interface between nanomaterials and biological systems, the organic and synthetic worlds merge into a new science concerned with the safe use of nanotechnology and nano- material design for biological applications. For this field to evolve, there is a need to understand the dynamic forces and molecular components that shape these interactions. While it is impossible to describe with certainty all the bio- physicochemical interactions at play at the interface, we are at a point where the pockets of assembled knowledge are providing a conceptual framework to guide this exploration, and review the impact on future product development. The book is intended as a valuable resource for academics and pharmaceutical scientists working in the field of polymers, polymers materials for drug delivery, drug delivery systems and ophthalmic drug delivery systems, in addition to medical and health care professionals in these areas.
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality."
Susan Quinn's extraordinary story takes the reader into the closed world of experimental "human trials" in which new drugs are developed. Both the portrait of a dedicated scientist and the archetypal story of all medical research, Human Trials is the emotion-laden, roller-coaster trip from the lab bench to the medicine cabinet, in which scientists risk their reputations, venture capitalists their millions, and patients their very lives. A Merloyd Lawrence Book
The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.
Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs. Nanopharmaceutics is one of the disciplines that will benefit the most from this technology.Nanotechnology will have a revolutionary impact on cancer diagnosis and therapy due to the exceptional characteristics of nanopharmaceutics.This book provides an overview of some tools, methods, and materials of nanotechnology that offer potential applications in pharmaceutics, followed by a series of examples showing applications that are already in development. It may very well inspire researchers to develop a new generation of pharmaceutics with inventive non-traditional approach and employ nanoscale science for the benefit of the patient.
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug Administration (FDA) to modernize regulations of pharmaceutical manufacturing and drug quality has helped position NIR spectroscopy as an effective tool for pharmaceutical testing. Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy: Second Edition reflects these developments and brings readers an up-to-date summary of how this technique is being applied to pharmaceutical manufacturing. Topics include: The origins and principles of NIR spectroscopy, including early instrumentation, spectroscopic theory, and light-particle interaction The physics of each instrument type, the strengths and weaknesses of each, and the manufacturers that produce them The possible advantages of using NIR methods for monitoring or controlling blending, as well as practical concerns for mixing processes NIR spectroscopy as applied to traditional granulation, drug layering, and film coating of beads or granules Pharmaceutical assays, including qualitative analysis, quantitative analysis, determination of actives in tablets and capsules, and considerations for intact dosage form analysis Steps involved in the validation and acceptance of an NIR spectroscopy method, including quality assurance, qualification and verification of instruments, and the International Conference on Harmonization (ICH) guidelines Medical applications, including those related to blood glucose measurements, tissue and major organ analysis, fetal analysis, and cancer research Providing comprehensive coverage of NIR spectroscopy, from theory, mathematics, application, and mechanics of NIR analysis, the book supplies ample references to facilitate further research into this burgeoning field.
"The chapters are organized well, and the preface explains how the concept of food is changing over time and how marine organisms are considered as healthy food." -P.N. Sudha, DKM College for Women, Tamil Nadu, India The relationship between food and health has been a growing concern in modern society, and the importance of information on their connection has elevated accordingly. People are becoming prone to diseases due to the deterioration of the environment. Despite a growing interest in preventative medicine in the healthcare sector, few medications can be called preventative drugs. Foods may exhibit completely different functions in a living body, depending on whether their components are simple substances providing energy and nutrition, or valid "functional entities." This book covers all aspects of healthcare solutions through marine-derived materials, with twenty-six chapters exploring an array of topics pertaining to human health in everyday life. Beginning with an introduction to food functionality and disease presentation, Chapters Two to Nine discuss chitin, chitosan, and the production and application of chitosan oligosaccharides regarding anti-cancer, anti-aging, and antioxidant activity. Furthermore, utilization of these cationic polysaccharides in artificial skin development, the prevention of alcohol consumption, dentistry, systemic diseases prevention and Alzheimer dementia are discussed in subsequent chapters. In Chapters Ten and Thirteen, I discuss obesity, osteoporosis, sexual dysfunction and sleep disorders using fisheries products. Additionally, Chapters Fourteen to Eighteen detail the use of marine algae to treat diabetics, allergy, asthma, AIDS and hair loss, as well as the use of fisheries products for hypertension and athlete's foot. Chapters Twenty-Two through Twenty-Six then shed light on the anti-aging effects of fish, the abundance of taurine in shellfish, antifreeze protein, food shortages through fish breeding, and cosmeceutical product development using marine organisms.
Interest in chemical entities capable of blocking or modifying cell metabolism ultimately goes back to the discovery of the structure of DNA in the 1950s. Understanding of the biochemical processes involved in cell metabolism rapidly led to the idea that compounds could be designed which might interfere with these processes, and thus could be used in the treatment of the diseases caused by viral infection. Since then, several classes of drugs have been discovered which depend for their effect on modification of the proper functioning of nucleic acids and, with the introduction of acyclovir for the treatment of Herpes infections, nucleoside analogues have become the cornerstone of antiviral chemotherapy. The success of the early nucleoside agents, the toxicity and metabolic instability of many nucleoside analogues, and the effects of viral pathogens on public health are driving the design, synthesis and evaluation of new nucleoside analogues, with much attention turning to nucleosides containing non natural' sugar analogues. This book focuses on the development of these agents, and draws together all the available material in an easily consulted form, which at the same time guides the reader into the research literature on the subject. Written primarily for the medicinal chemist, coverage includes both synthetic strategies and outline guidance on the main trends in biological activity. Particular attention is drawn to the comparison of synthetic routes to compounds with their natural analogues. Finally, the important antiviral activities of the compounds are treated, including anti-retrovirus, anti-hepadnavirus and anti-herpes virus properties. Written mainly for medicinal chemists inthe pharmaceutical industry and synthetic organic chemists in academe, this book will also be attractive to researchers in institutions focusing on cellular metabolism. Advanced students of organic chemistry will find the clear discussion of the synthetic strategies adopted in the development of these compounds a useful introduction to this exciting and challenging area.
This volume contains the proceedings of the Eighth International Symposium on Cyclodextrins, held in Budapest, Hungary, March 31-April 2, 1996. The 147 papers collected here are milestones in the exponentially increasing cyclodextrin literature, and represent a summary of the last two years' achievement in this field, with applications in such diverse disciplines as pharmaceuticals, food, cosmetics, textiles, plastics, and chromatography. Some highlights: lipophilicity profiles of cyclodextrins by computer molecular graphics; recent toxicological studies on cyclodextrins; Buckminsterfullerene/cyclodextrin complexes; hydroxypropyl-beta-cyclodextrin; pharmacokinetics and toxicology; peracylated cyclodextrins as drug carriers; cyclodextrins in nasal drug delivery; textile fibre surface modification by a reactive cyclodextrin; cyclodextrin-containing fabric care products; drug targeting by cyclodextrin-dimers for photodynamic cancer therapy; cyclodextrins in ophthalmologic drugs; new cyclodextrin derivatives and their potentials. Audience: This book will be of interest to researchers whose work involves pharmaceuticals, food chemicals and flavours, food additives, chromatographic methods, and biotechnology, as well as fundamental cyclodextrin research.
Volume 47 of "Progress in Drug Research" contains eight reviews and the various indexes which facilitate its use and establish the connection with the previous volumes. The articles in this volume deal with inotropic steroids, with chemokines and their involvement in a wide range of inflam- matory diseases, with the subclassification and nomenclature of ul- and Uz-adrenoceptors, with Chinese traditional medicine, with drug targets in the molecular pathogenesis of asthma, with cytokines and their therapeutic application in immunosuppression and immunostimulation, with alter- native medicine and with the potential use of calcium blockers in psy- chiatry. These reviews and the quotations of original articles provide the reader with valuable information on several new developments in the world-wide search for new and better medicines. In 1959, when the Editor started this series of monographs, it was his intention to help disseminate informa- tion on the vast and fast growing domain of drug research. Already at that time,it was not possible to follow the major individual publications in this field, and the reader was thereby provided with a tool to keep abreast of the latest developments and trends. This goal remained unchanged over the last 37 years, and I believe that the reviews in PDR are useful to the non-specialist who can obtain an overview of a particular field of drug research in a relatively short time.
Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca- demic environments, forcing pharmaceutical scientists to explore a domain previ- ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad- ministration have been examined for proteins, no real, generally applicable alter- native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.
Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many PET centres participate in networks that warrant the quality of their research. PET allows one to follow the effect of a drug on a variety of patients' metabolic parameters. In addition, PET may be used to follow the fate in vivo of a compound, allowing visualisation of its binding to specific receptors and a direct study of the mechanism of drug action in normal and pathological situations. The book shows the fields in which PET offers new and unique information for the development of drugs (conception, toxicity, pharmacokinetics and metabolism, clinical research, and relations between clinical and biological effects) and evaluates fields in which PET may shorten the development time of drugs. Audience: Professionals in the pharmaceutical industry in all areas of drug discovery and pharmacology, pre-clinical testing, pharmacokinetics and metabolism, clinical evaluation, registration and regulatory affairs. Government health authority representatives who assess data and documentation on new drug development and radiopharmaceuticals. Academic experts concerned with any of these areas.
Nearly three thousand papers and patents are dedicated to the actual or potential uses of cyclodextrins in pharmacy and pharmaceutical formulations. This is the first book written for pharmacists and pharmaceutical technologists which not only critically summarizes the enormous amount of literature available, but which can be used as a handbook when looking for solutions to practical problems. The fundamentals -- chemistry of cyclodextrins and their derivatives -- their physical and chemical properties are condensed to the most relevant items in Chapters 1 and 2. Chapter 3 deals with the adsorption, metabolism and toxicological properties of cyclodextrins. Chapter 4 explains the formulation, structure, composition and advantageous effects of the cyclodextrin inclusion complexes. Chapter 5 describes the methods for preparation and characterization of drug/cyclodextrin complexes. Chapters 6 and 7 are dedicated to the pharmacokinetics, biopharmaceutical and technological aspects of drug/CD complexes. Chapter 8 treats the application and effects of cyclodextrins in various drug formulations. The Appendix comprises a collection of recipes for any type of drug formulation. This book is aimed at those who use cyclodextrins in drug formulations, to improve the properties of existing drug formulations, or who want to prepare quite new formulations.
During the past decade there have been many changes in the perfumery industry which are not so much due to the discovery and application of new raw materials, but rather to the astronomic increase in the cost of labour required to produce them. This is reflected more particularly in the flower industry, where the cost of collecting the blossoms delivered to the factories has gone up year after year, so much so that most flowers with the possible exception of Mimosa, have reached a cost price which has compelled the perfumer to either reduce his purchases of absolutes and concretes, or alternatively to substitute them from a cheaper source, or even to discontinue their use. This development raises an important and almost insoluble problem for the perfumer, who is faced with the necessity of trying to keep unchanged the bouquet of his fragrances, and moreover, to ensure no loss of strength and diffusiveness. Of course, this problem applies more especially to the adjustment of formulae for established perfumes, because in every new creation the present high cost of raw materials receives imperative con sideration before the formula is approved."
This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.
This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg (R)), Brentuximab vedotin (Adcetris (R)), and ado-trastuzumab emtansine (Kadcyla (R)), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.
The book that highlights mass spectrometry and its application in characterizing proteins and peptides in drug discovery
An instrumental analytical method for quantifying the mass and characterization of various samples from small molecules to large proteins, mass spectrometry (MS) has become one of the most widely used techniques for studying proteins and peptides over the last decade. Bringing together the work of experts in academia and industry, "Protein and Peptide Mass Spectrometry in Drug" Discovery highlights current analytical approaches, industry practices, and modern strategies for the characterization of both peptides and proteins in drug discovery.
Illustrating the critical role MS technology plays in characterizing target proteins and protein products, the methods used, ion mobility, and the use of microwave radiation to speed proteolysis, the book also covers important emerging applications for neuroproteomics and antigenic peptides. Placing an emphasis on the pharmaceutical industry, the book stresses practice and applications, presenting real-world examples covering the most recent advances in mass spectrometry, and providing an invaluable resource for pharmaceutical scientists in industry and academia, analytical and bioanalytical chemists, and researchers in protein science and proteomics.
The first comprehensive book on the biology and ecology of pharmaceutical cnidarians, answering a need for more knowledge about the identification, biology, natural products and bioactivities of these living resources. Contributed by scientists of both marine biology and pharmacy disciplines. Identifies the correct marine species, shows the ecological parameters of that species, and explores its biological values with particular attention to primary and secondary metabolites or bioactive constituents. A useful supplementary text on Marine Biology and Pharmacology courses. Nearly 200 illustrations are produced in full color, providing a high-quality reference. This book provides the taxonomy, common name, global distribution, habitat, diagnostic features, and pharmaceutical compounds (along with their activities) of 200 species of marine cnidarians along with nearly 200 detailed illustrations in glorious color. The phylum Cnidaria (formerly Coelenterata) is a large, diverse, and ecologically important group of marine invertebrates which make up 40 percent of the biomass of the oceans. Marine invertebrates are the richest source of marine natural products with potential applications in the pharmaceutical and medical sectors, and it has been reported that over 3000 bioactive compounds have been described from this phylum alone, mostly in the last decade.
Natural products and functional/medical foods are now widely acknowledged as having an effect on the microbiome of the intestine, which in turn influences the outcome of certain disease. This book reviews the impact and effects of natural products and functional/medical foods (nutritional programming) on disease management, specifically focusing on diseases related to 1) Inflammation and Immunity, 2) Cancer, COPD and Cachexia, 3) Allergy and 4) Brain Neuro/Immune. Hippocrates said "let medicine be thy food and food be thy medicine". While most of us are familiar with Hippocrates famous words, we admit that in recent times, the disciplines of pharma and nutrition have evolved separately. Today, with the ever growing burden of diseases in modern society, we see a convergence of the two in relation to specific disease prevention and treatment. This re-discovered common ground between the complementary values of pharma and nutrition can be conceptualized in the term pharma-nutrition. Various chapters in the book review the aspects of molecular characteristics of food ingredients towards clinical effectiveness and relevance.
Ethnobotany includes the traditional use of plants in different fields like medicine and agriculture. This book incorporates important studies based on ethnobotany of different geographic zones. The book covers medicinaland aromatic plants, ethnopharmacology, bioactive molecules, plants used in cancer, hypertension, disorders of the central nervous system, and also as antipsoriatic, antibacterial, antioxidant, antiurolithiatic. The book will be useful for a diverse group of readers including plant scientists, pharmacologists, clinicians, herbalists, natural therapy experts, chemists, microbiologists, NGOs and those who are interested in traditional therapies.
Sets the stage for advances in drug discovery using the latest enzyme technology
Reviewing new and emerging applications of enzyme technology in drug discovery, this book highlights some of the most promising areas of pharmaceutical and biotechnology research. It covers enzyme assay technology, utilization of enzymology for prodrug design, and the application of enzymes as therapeutic agents. Expert reviews highlight how our latest understanding of enzymology is used to develop new practical applications in drug discovery and design.
Filled with case studies, "Enzyme Technologies: Pluripotent Players in Discovering Therapeutic Agents" enables readers to better understand the diverse functions of enzymes and master specific applications in drug discovery research. In addition to small molecule drug discovery, the book explores new developments in enzymes as therapeutic agents for genetic disorders.Section A, Enzymes - Essential Workhorses in Pharmaceutical Research, offers support in selecting the best enzyme targets for drug discovery, designing enzyme inhibitors for therapeutic agents, and evaluating selective enzyme inhibitors.Section B, Enzymes - Indispensable Tools for Improving Druggability, sets forth the principles alongside real-world examples of exploiting specific properties of enzymes to design successful prodrugs.Section C, Enzymes - Powerful Weapons for Correcting Nature's Errors, provides new insights on applying enzymes as therapeutic agents or diagnostic tools to treat genetic disorders.
Chapters are contributed by leading experts from around the world. Their contributions are based on a thorough review of the current literature as well as their own research.
Reviewing our latest understanding of the nature of enzymes and their role in drug discovery, this book is recommended for researchers in pharmaceuticals and biotechnology as well as for researchers in enzymology, biochemistry, molecular biology, and medicinal chemistry.
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