This book considers the rapid microbiological techniques that are now increasingly used in industry as alternatives to more conventional methods. Although many of the pioneering studies in this field have taken place in clinical laboratories, the materials listed and organisms sought for foods, beverages and pharmaceuticals are much more varied. In this volume, leading experts from research and industry review the wide variety of approaches that are needed in an industrial setting. The methods described include electrometric techniques, ATP assay, and immunological methods for a wide range of organisms from salmonellas to viruses, each chapter drawing on the authors direct experience in industry to give a highly practical guide. The book should prove invaluable to those in the food, beverage and pharmaceutical industries, or in research and training, who require an up-to-date survey of the use of rapid microbiological methods.

In my professional career as a pharmaceutical scientist, I have been involved with severalaspectsofthe drugdevelopmentprocessfrompre-INDto commercialization and, somehow, I usually found myself coming back to a stability-related issue. The stability area seemed to draw my utmost interest because in my day-to-day work, my opportunities involved more than one product, and none of the issues were the same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment, an understandingof regulations, a knowledgeof science, a graspof compliance, and an appreciation of common practices. Sinceearly2000, Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I struggled to ?nd good, concise, practical resources, one of which I could just hand to a new scientist who wishes to gain a greater understanding of stability sciences. In addition, I encountered the same questions posted over and over on different stability best practices discussion forums. As a book lover, I also have a good collection of technical books. Unfor- nately, most of the stability related volumes are outdated. Many of these materials are theoretical and do not contain much practical information. I understand that the pharmaceutical industry during this period is quite volatile, and guidelines are changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac- tical industryto accommodatethese changes;however, thefundamentalinformation continues to remain quite the same, just as current Good Manufacturing Practices (cGMP) continue to be the standard industry practice. Therefore, I hoped to ass- ble a practical handbook to ?ll this v

The treatment of children with medicinal products is an important scientific area. It is recognized that many medicines that are used extensively in pediatric patients are either unlicensed or off-label. This textbook will help pediatric health professionals select the most appropriate medication to effectively treat children and ensure minimal side effects.

In developing countries, access to affordable medicines for the treatment of diseases such as AIDS and malaria remains a matter of life or death. In Africa, for instance, more than one million children die each year from malaria alone, a figure which could soon be far higher with the extension of patent rules for pharmaceuticals. Previously, access to essential medicines was made possible by the supply of much cheaper generics, manufactured largely by India; from 2005, however, the availability of these drugs is threatened as new WTO rules take effect. Halting the spread of malaria and HIV/AIDS is one of the eight Millennium Goals adopted at the UN Millennium Summit, which makes this a timely and topical book. Informed analysis is provided by internationally renowned contributors who look at the post-2005 world and discuss how action may be taken to ensure that intellectual property regimes are interpreted and implemented in a manner supportive to the right to protect public health and, in particular, to promote access to medicines for all.

Finding current, detailed information on the analysis of drug-related compounds is challenging at best. While almost everyone engaged in the study of these compounds has accumulated a vast variety of data over time, a single-source, comprehensive review of that data would be an invaluable resource to have. Instrumental Data for Drug Analysis (IDDA), Third Edition is that resource, presenting the latest information on these compounds in a thorough, straightforward format. What's new in the Third Edition: Presents FT-Raman Spectra tables Includes information and analysis relating to 125 new drugs, including Zoloft, Claritin, Ambien, and the latest generation of narcotics Organizes information on each drug in a simple, streamlined format

This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.

In the next couple of years the human genome will be fully sequenced. This will provide us with the sequence and overall function of all human genes as well as the complete genome for many micro-organisms. Subsequently it is hoped, by means of powerful bioinformatic tools, to determine the gene variants that contribute to various multifactorial diseases and genes that exist in certain infectious agents but not humans. As a consequence, this will allow us to define the most appropriate levels for drug intervention. It can be expected that the number of potential drug targets will increase, possibly by a factor of 10 or more. Nevertheless, sequencing the human genome or, for that matter, the genome of other species will only be the starting point for the understanding of their biological function. Structural genomics is a likely follow-up, combined with new techniques to validate the therapeutic relevance of such newly discovered targets. Accordingly, it can be expected that in the near future we will witness a substantial increase in novel putative targets for drugs. To address these new targets effectively, we require new approaches and innovative tools. At present, two alternative, yet complementary, techniques are employed: experimental high-throughput screening (HTS) of large compound libraries, increasingly provided by combinatorial chemistry, and computational methods for virtual screening and de novo design. As kind of status report on the maturity of virtual screening as a technique in drug design, the first workshop on new approaches in drug design and discovery was held in March 1999, at Schloss Rauischholzhausen, near Marburg in Germany. More than 80 scientists gathered and discussed their experience with the different techniques. The speakers were invited to summarize their contributions together with their impressions on the present applicability of their approach. Several of the speakers followed this request which is summarized in this publication."

A significant improvement in the safety of modern vaccines has been the development of subunit vaccines, as these are composed of very well-defined and highly pure components, often recombinant proteins. However, since protein-based antigens in general are weakly immunogenic by themselves, co-administration of adjuvants is required to induce potent and persistent specific immune responses. In recent years, there has been substantial progress in the discovery of new efficient adjuvants for subunit vaccines that are often classified into delivery systems and immunopotentiating compounds that constitute pathogen-associated molecular patterns, such as the toll-like receptor ligands. The combination of delivery systems and immunopotentiators has appeared to represent extraordinarily good adjuvants due to concomitant enhanced antigen delivery and potent stimulation of innate immunity. Many of these adjuvants are of a particulate nature and mimic the structure and/or composition of microbes in a reductionist fashion. Examples are liposomes, polymeric nanoparticles, emulsions and virus-like particles. However, there are a substantial number of pharmaceutical challenges associated with the subunit vaccine development process due to the complex nature of the antigen-adjuvant combinations. These challenges will be presented and discussed in this book. The objective of the book is to compile the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. The books goal is to provide a comprehensive overview of the scientific and regulatory challenges facing scientists who research and develop subunit vaccines. The scope of the book is wide. It is written in a manner that will enlighten newcomers to the field (e.g., PhD students or experienced scientist switching fields) yet provide an in-depth knowledge that would benefit a skilled worker in the field. "

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.

Interconnecting the fundamentals of supercritical fluid (SCF) technologies, their current and anticipated utility in drug delivery, and process engineering advances from related methodological domains and pharmaceutical applications, this volume unlocks the potential of supercritical fluids to further the development of improved pharmaceutical products-from drug powders for respiratory delivery to drug delivery systems for controlled release.

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.

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.

Provides instructions on small-scale soap production methods. A practical introduction, with many illustrations, based on the author's experiences in Ghana.

The book targets new advances in areas of treatment and drug delivery sciences for tuberculosis. It covers advances in drug therapy and drug targeting that focus on innovative trend defining technologies and drug delivery platforms in the understanding of host-pathogens relationship for providing better therapy. A wide variety of novel and nano-formulations using promising technologies are being explored to deliver the drug via different administration routes. This book It addresses the gap between new approaches and old treatment modalities and how they are superior in pharmacological performance when tested in in-vitro and in-vivo. Audience from wide range group like from researchers to regulatory bodies can benefit from the compiled information to find out patient needs and current research advances in the field of tuberculosis research.

The marine environment has been, and continues to be, a fruitful source of novel chemical compounds that are not found in terrestrial and freshwater organisms. Many of these substances show potential biomedical applications, which could lead to development of new pharmaceutical products. Research on the utilization of natural products from marine organisms is growing by leaps and bounds; one important reason why being that, investigators, through new diving technologies, are becoming able to explore at greater depths. Studies of these marine natural products include investigations of neuronal membrane-active toxins, ion channel blockers, antitumor and antiviral agents, and anti-inflammatory molecules. This volume is the sixth in the ongoing series.

Progress in Drug Research is a prestigious book series (founded in 1959) which provides extensive expert-written reviews on a wide spectrum of highly topical areas in current pharmaceutical and pharmalogical research. Each volume contains fully cross-referencing indexes which link the volumes together, forming a virtually encyclopaedic work. The series thus serves as an important, time-saving source of information for researchers concerned with drug research and all those who need to keep abreast of the many recent developments in the quest for new and better medicines.

Volume 50 in the series includes:

P.N. Kaul: Drug discovery: Past, present and future

M. Rohmer: Isoprenoid biosynthesis via the mevalonate -- independent route, a novel target for antibacterial drugs

G. Edwards and A.H. Weston: Endothelium, -derived hyperpolarizing factor -- a critical appraisal

R.W. Rockhold: Glutamatic involvement in psychomotor stimulant action

J.M. Colacino and K.A. Staschke: The identification and development of antiviral agents for the treatment of chronic hepatitis B virus infection

T.D. Johnson: Polyamines and cerebral ischemia

This handbook is unique in its comprehensive coverage of the subject and focus on practical applications in diverse fields. It includes methods for sample preparation, the role of certified reference materials, calibration methods and statistical evaluation of the results. Problems concerning inorganic and bioinorganic speciation analysis, as well as special aspects such as trace analysis of noble metals, radionuclides and volatile organic compounds are also discussed. A significant part of the content presents applications of methods and procedures in medicine (metabolomics and therapeutic drug monitoring); pharmacy (the analysis of contaminants in drugs); studies of environmental samples; food samples and forensic analytics - essential examples that will also facilitate problem solving in related areas.

This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs.

Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage formsRefillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devicesIntravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of deliveryPhysical methods including iontophoresis for drug deliveryRational selection of routes of administration and delivery systemsNoninvasive and continuous drug monitoring Regulatory path to drug product developmentClinical endpoints for drug product developmentEmerging and existing drugs and drug targets

"Drug Product Development for the Back of the Eye" is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. "

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 Handbook of Pharmaceutical Controlled Release Technology reviews the design, fabrication, methodology, administration, and classifications of various drug delivery systems, including matrices, and membrane controlled reservoir, bioerodible, and pendant chain systems. Contains cutting-edge research on the controlled delivery of biomolecules! Discussing the advantages and limitations of controlled release systems, the Handbook of Pharmaceutical Controlled Release Technology -covers oral, transdermal, parenteral, and implantable delivery of drugs -discusses modification methods to achieve desired release kinetics -highlights constraints of system design for practical clinical application -analyzes diffusion equations and mathematical modeling -considers environmental acceptance and tissue compatibility of biopolymeric systems for biologically active agents -evaluates polymers as drug delivery carriers -describes peptide, protein, micro-, and nanoparticulate release systems -examines the cost, comfort, disease control, side effects, and patient compliance of numerous delivery systems and devices -and more!

Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design.
Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication.
Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis
discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability
analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology
examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods
highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry
demonstrates uses of unnatural mutagenesis and combinatorial chemistry
explores mass spectrometry, protein sequence, and carbohydrate analysis
illustrates bioassays and other new functional analysis methods
surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR)
addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells
reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering
and more
Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemists; cell and molecular biologists; biochemists; and upper-level undergraduate and graduate students in these disciplines.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors.

Early anthropological evidence for plant use as medicine is 60,000 years old as reported from the Neanderthal grave in Iraq. The importance of plants as medicine is further supported by archeological evidence from Asia and the Middle East. Today, around 1.4 billion people in South Asia alone have no access to modern health care, and rely instead on traditional medicine to alleviate various symptoms. On a global basis, approximately 50 to 80 thousand plant species are used either natively or as pharmaceutical derivatives for life-threatening conditions that include diabetes, hypertension and cancers. As the demand for plant-based medicine rises, there is an unmet need to investigate the quality, safety and efficacy of these herbals by the "scientific methods". Current research on drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, analytical, and molecular techniques. For instance, high throughput robotic screens have been developed by industry; it is now possible to carry out 50,000 tests per day in the search for compounds which act on a key enzyme or a subset of receptors. This and other bioassays thus offer hope that one may eventually identify compounds for treating a variety of diseases or conditions. However, drug development from natural products is not without its problems. Frequent challenges encountered include the procurement of raw materials, the selection and implementation of appropriate high-throughput bioassays, and the scaling-up of preparative procedures. Research scientists should therefore arm themselves with the right tools and knowledge in order to harness the vast potentials of plant-based therapeutics. The main objective of Plant and Human Health is to serve as a comprehensive guide for this endeavor. Volume 1 highlights how humans from specific areas or cultures use indigenous plants. Despite technological developments, herbal drugs still occupy a preferential place in a majority of the population in the third world and have slowly taken roots as alternative medicine in the West. The integration of modern science with traditional uses of herbal drugs is important for our understanding of this ethnobotanical relationship. Volume 2 deals with the phytochemical and molecular characterization of herbal medicine. Specifically, it will focus on the secondary metabolic compounds which afford protection against diseases. Lastly, Volume 3 focuses on the physiological mechanisms by which the active ingredients of medicinal plants serve to improve human health. Together this three-volume collection intends to bridge the gap for herbalists, traditional and modern medical practitioners, and students and researchers in botany and horticulture.

This book illustrates the importance of the Natural Biometabolites, which offer a rich reservoir of candidate compounds for drug discovery in the battle against cancer. Recent research and development efforts concerning anti-cancer drugs derived from natural products have led to the identification of numerous candidate molecules that inhibit cancer cell proliferation and metastasis using a variety of mechanisms. Given its scope, the book offers a valuable resource for cancer biologists and general oncologists alike, while also benefitting research professionals in Science, Nursing, Medicine, Biochemistry, Genetics and Bioscience who wish to understand the fundamentals of prognosis and prediction in tumorigenesis. Moreover, the book provides an essential platform for understanding drug resistance mechanisms and combatting the growing menace of multidrug resistance.

This book focuses on the different compounds (polyphenols, sterols, alkaloids terpenes) that arise from the secondary metabolism of plants and fungi and their importance for research and industry. These compounds have been the backbone and inspiration of various industries like the food, pharmaceutical and others to produce synthetic counterparts. Furthermore, many of these compounds are still widely used to carry out specific functions in all these industries. This book offers a compilation of different texts from world leading scientists in the areas of chemistry, biochemistry, plant science, biotechnology which compile information on each group of secondary metabolism compounds, and their most important applications in the food, pharmaceutical, cosmetic and textile industry. By showcasing the best uses of these compounds, the chemistry behind their production in plants and fungi, this book is a valuable resource and a "go to" artifact for various audiences. The new approach this book offers, by linking research and the application of these compounds, makes it interesting as an inspiration for new research or as a hallmark of what has been done in the secondary metabolism of plants and fungi in recent years. Although this book may be technical, it is also enjoyable as an integral reading experience due to a structured and integrated flow, from the origins of secondary metabolism in organisms, to the discovery of their effects, their high intensity research in recent years and translation into various industries. Beyond learning more on their chemistry, synthesis, metabolic pathway, readers will understand their importance to different research and industry.