Proceedings of the First International Workshop on Lantibiotics, April 15-18, 1991, Physikzentrum Bad Honnef, F.R.G.

This book describes the latest developments in technologies that can be used to obtain the 3-D structures including the high profile structural genomics approaches being utilised worldwide. The use of 3-D protein structures in new, Fragment-based, approaches to drug discovery are described in some detail. This book includes experimental approaches using X-ray crystallography and NMR for Fragment-based screening as well as other biophysical methods for studying protein/ligand interactions. In addition, developments in computational chemistry methodology are covered together with an assessment of practical applications.

Key Points: 1. Discusses the role of microbial enzymes in functional food and nutraceutical production 2. Covers a range of enzymes like proteases, pullulanases, lipases 3. Explores various microbial sourcess and processing techniques 4. Reviews application of enzymes in synthesis of chiral drug intermediates 5. Examines molecular techniques on improving microbial enzymes properties and ability

A suitable drug delivery system is an essential element in achieving efficient therapeutic responses of drug molecules. With this desirability in mind, the book unites different techniques through which extremely small-sized particles can be utilized as a successful carrier for curing chronic as well as life-threatening diseased conditions. This is a highly informative and prudently organized book, providing scientific insight for readers with an interest in nanotechnology. Beginning with an overview of nanocarriers, the book impetuses on to explore other essential ways through which these carriers can be employed for drug delivery to varieties of administrative routes. This book discusses the functional and significant features of nanotechnology in terms of Lymphatic and other drug targeting deliveries. The book is presenting depth acquaintance for various vesicular and particulate nano-drug delivery carriers, utilized successfully in Pharmaceutical as well as in Cosmeceutical industries along with brief information on their related toxicities. In addition, the work also explores the potential applications of nanocarriers in biotechnology sciences for the prompt and safe delivery of nucleic acid, protein, and peptide-based drugs. An exclusive section in the book illuminates the prominence and competent applicability of nanotechnology in the treatment of oral cancer. The persistence of this book is to provide basic to advanced information for different novel carriers which are under scale-up consideration for the extensive commercialization. The book also includes recent discoveries and the latest patents of such nanocarriers. The cutting-edge evidence of these nanocarriers available in this book is beneficial to students, research scholars, and fellows for promoting their advanced research.

Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: "Descriptions of and comments on new guidelines and standards "Technological advances - such as the new breed of sanitizing gas generators "Updates that reflect current thinking and new information Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.

Until now, the area of drug metabolism and pharmacokinetics has been lacking in texts written for the Medicinal Chemist. This outstanding book, aimed at postgraduate medicinal chemists and those working in industry, fills this gap in the literature. Written by medicinal chemists and ADMET scientists with a combined experience of around 300 years, this aid to discovering drugs addresses the absorption, distribution, metabolism, excretion and toxicity (ADMET) issues associated with drugs. The book starts by describing drug targets and their structural motifs before moving on to explain ADMET for the medicinal chemist. It is the functional groups which most profoundly influence the drug molecules of which they form a part. They characterise the pharmacology, are essential to the activity, and alter the ADMET characteristics of each drug. Their effects follow a pattern, thus allowing medicinal chemists to predict and overcome potential challenges. For this reason, the Editors have taken the unique approach of dividing the remainder of the book into chapters which each focus on a different functional group. They describe drugs containing the functional group under consideration, explain why the group is there, and outline its physicochemical properties before going on to detail the ADMET issues. Where possible, prodrugs and bioisosteres, which may give alternative ADMET outcomes, are described. The chapters cross refer where similar matters are covered but individual chapters can be used in a stand alone manner. The book ends with a discussion of future targets and chemistry needs.

This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs. It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapy strategies.

Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. This is not a "cookbook" of easy-to-follow recipes. It is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

Numerous herbal plants are used as an important source of life saving drugs for the world's population. Herbal plants are the natural source of several medicines, mainly due to their secondary metabolites, and have long been in use as medicine in the crude extract form. They are also used to isolate the bioactive compounds in modern medicine and herbal medicine systems. They play an important role in the development, synthesis, and formulation of new drugs. Includes chapters on relevant topics contributed by experts of the subjects to make available a comprehensive treatise with in-depth analysis. Audience - those specifically in herbal plant-based drug formulation - presents biotechnological techniques to obtain the desirable products from some specific herbal plants.

Extensively revised and updated, this second edition compares conventional and innovative drug delivery systems. The book covers significant ophthalmic advances and breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery. It examines procedures in pharmacokinetic/pharmacodynamic modeling for the determination of appropriate dosing regimens, covers new developments in animal modeling, and discusses current regulations governing patenting, commercial product release, and human testing. This in-depth reference lays the groundwork for overcoming constraints on the delivery of ophthalmic drugs.

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more. Martin Easter and his panel of experts: Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products. Features

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

This book offers a comprehensive study of biological molecules acquired from marine organisms, which have been exploited for drug discovery with the aim to treat human diseases. Biomolecules have potential impacts on a diverse range of fields, including medical and pharmaceutical science, industrial science, biotechnology, basic research, molecular science, environmental science and climate change, etc. To understand and effectively apply medicinally important biomolecules, multidisciplinary approaches are called for. The ocean remains a rich biological resource, and the vast untapped potential of novel molecules from marine bio-resources has caught the interest of more and more researchers. These novel biological compounds have never been found in terrestrial or other ecosystems, but only in this rich niche. Advances in sampling techniques and technologies, along with increased funding for research and nature conservation, have now encouraged scientists to look deeper in the waters. Aquaculture supports both tremendous seafood production and the bulk production of marine-derived drugs. Furthermore, molecular methods are now being extensively employed to explore the untapped marine microbial diversity. With the help of molecular and biotech tools, the ability of marine organisms to produce new biosynthetic drugs can be greatly enhanced. This book provides an extensive compilation of the latest information on marine resources and their undisputedly vital role in the treatment of diverse ailments.

This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics.

This book covers the recent innovations relating to various bioactive natural products (such as alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, volatile oils, fixed oils, fats and waxes, proteins and peptides, vitamins, marine products, camptothecin, piperines, carvacrol, gedunin, GABA, ginsenosides) and their applications in the pharmaceutical fields related to academic, research and industry.

Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials. The book covers: -Objectives of the clinical study -Control of the study -Conduct of the study -Regulation versus compliance -Factors for success -International harmonization activities -Roles of the investigator, the monitor, and the practicing veterinarian -Setting up GCP trials with particular animal species -SOPs, the generic protocol, and the study report -Contract research farms and multi-site studies -Auditing With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls.

This book presents a multidisciplinary assessment of the state of science in the use of systemic delivery technologies to deliver anti-aging therapeutics now under development. There is a gap between basic aging research and the development of intervention technologies. This major obstacle must be overcome before biogerontological interventions can be put into clinical practice. As biogerontology comes to understand aging as a systemic degenerative process, it is clear that there is a pressing need for technologies that enable cells and tissues in a fully developed adult body to be manipulated systemically to combat aging. The authors review advances in the chemistry and engineering of systemic delivery methods and analyze the strengths and limitations of each. The book is organized into six sections. The first offers an overview of the need for systemic delivery technologies alongside the development of anti-aging therapies and describes approaches that will be required for studying the properties and efficiency of carriers for systemic delivery. Sections II, III and IV describe recent advances in a range of strategies that may enable systemic delivery to help combat aging conditions ranging from cell senescence to decline in immune function and hormonal secretion. Section V discusses practical strategies to engineer and optimize the performance of delivery technologies for applications in systemic delivery, along with their working principles. The final section discusses technical and biological barriers that must be overcome as systemic delivery technologies move from research laboratory to clinical applications aimed at tackling aging and age-associated diseases.Benefiting scholars, students and a broader audience of interested readers, the book includes helpful glossary sections in each chapter, as well as sidebars that highlight important notes, and questions for future research.

Demonstrates how substitution of a variety of ligands can render albumin a versatile targeting tool for selective drug accumulation in various cell populations of the liver
This book discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inhalation delivery, and the development of original formulations that are matched by innovative device design.
Considers the efforts in biotechnology and molecular biology to produce intelligent drug delivery devices by exploiting biological pathways
Containing over 1100 references to facilitate further study, Drug Targeting Technology
updates recent progress in oral and colonic targeting technology using pH- and enzyme-sensitive coating materials and novel polymer systems
shows how the systemic distribution of drugs can be modulated by lipid-based carriers taking alternative routes of transport, particularly lymph flow
details soft drugs that are rapidly metabolized to inactive and nontoxic metabolites and removed efficiently from the body
includes successful designs of virus-like liposomal delivery systems that offer the advantages of viral carriers
supplies examples of how viral delivery systems can be directed to cancer sites
and more
Suggesting harnessing biological processes as the ultimate approach to the delivery or expression of pharmacologically active agents, Drug Targeting Technology is a top-shelf reference for pharmacists, pharmacologists, and pharmaceutical scientists; analytical, surface, physical, and colloid chemists and biochemists; and upper-level undergraduate and graduate students in these disciplines.

Instant Notes in Medicinal Chemistry provides concise coverage for undergraduates studying medicinal chemistry as part of a science, pharmacy or medical course. It is a truly multidisciplinary subject involving such subject specialities as organic chemistry, pharmacology, biochemistry, physiology, microbiology, toxicology, genetics and computer modeling. It concentrates on the fundamental principles of medicinal chemistry and assumes no more than elementary background of chemistry or biology.

This book reviews the current state of ocular drug therapy and future therapeutic opportunities for a wide variety of conditions, including Age-related Macular Degeneration, Diabetic Retinopathy and Macular Edema, Glaucoma, and Inherited Retinal Diseases. Retinal diseases are major contributors to moderate or severe vision impairment in adults aged 50 years and older. The respective patient populations for many of these indications is expected to significantly increase as the world population continues to grow older. An improved understanding of the etiological underpinnings of ocular degenerative diseases over the past decade has significantly bolstered ophthalmic drug discovery. In this volume, contributions from leading experts explore the unique challenges faced for ocular drug discovery and delivery providing the reader with detailed information on ocular pharmacokinetics, in vitro, ex vivo and in vivo models for retinal disease pathology and emerging gene therapy treatments. The book is intended for all researchers and clinicians who wish to increase their knowledge on the latest findings in ocular drug therapy.

This comprehensive text presents a rigorous framework from within which regulators can respond strategically to the claim by the pharmaceutical industry that lower drug prices today lead to a loss for the population's future health due to less innovation. It starts with a critical review of the empirical evidence of the return to consumers on their ongoing investment into high drug prices in order to increase future innovation. The implicit, critical and unrealistic assumption inherent in these studies is identified, namely that the health budget can be expanded to purchase drugs at higher prices without an opportunity cost, for example, the foregone benefits of alternative investments in health care infrastructure. Price effectiveness analysis (PEA), is introduced. PEA informs the question of how the innovative surplus from the new drug should be allocated between the manufacturer and the consumer so as to optimise society's welfare. The method allows the decisions by the regulator and the firm to be analysed jointly by specifying the firm's production and revenue functions in terms of the clinical innovation of a new drug; the incremental effect used in the summary metric of cost effectiveness analysis. An economic value of innovation that takes into account opportunity cost under conditions of economic efficiency in the health system is proposed: the health shadow price. The limitations of the non-strategic methods that currently inform the highly contested new drug subsidy game are presented and the relative strengths of PEA are demonstrated. Health technology assessment quantifies both the clinical innovation of a new drug and its financial impact on the health system. Cost effectiveness analysis tests the relationship between the incremental cost and incremental effect of a new drug for target patients, at a given price. PEA tests the relationship between the price of a new drug and the health of the whole population, now and into the future. It achieves this by taking into account current inefficiency in both resource allocation and the displacement process, and the relationship between price and future innovation.

This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating.
Reveals unique approaches in pharmaceutical solid science not previously published in any other text
Providing current data on crystallization, dissolution from particles and polydisperse populations, powder volumes and densities, comminution, wet granulation, and hard-shell capsules, Advanced Pharmaceutical Solids
describes moisture isotherms with crystalline solids
documents the effects of moisture on solid-state stability
highlights tablet physics and principles
explains sustained release by microencapsulation
presents prediction equations for solubility in binary solvents
discusses particle sizes and diameters
identifies Brunauer, Emmett, and Teller Isotherms
and more
Considering properties of solids, permeamitry and gas absorption methods, amorphates, and purification by pH-change precipitation, Advanced Pharmaceutical Solids is an essential reference for pharmacists; pharmaceutical scientists; medicinal, physical, surface, colloid, and analytical chemists and biochemists; and an effective text for upper-level undergraduate and graduate students in these disciplines.