This book presents a comprehensive and up to date account of the chemotherapy of parasitic diseases, both human and veterinary. The book starts with an overview of parasitic diseases. The body of the book is divided into two parts: antihelminthic drugs, and antiprotozoal drugs. Both parts start with chapters highlighting the 'biochemical targets' available for chemotherapeutic interference. Individual chapters deal with one chemical class of compounds and describe their origin, structure-activity relationship, mode of action, and methods of synthesis and their status both in clinical and veterinary practice. The book will be useful to a wide spectrum of readers: students embarking on a research career in parasitic chemotherapy, clinicians (and veterinarians) and clinical pharmacologists desiring detailed information about the drugs currently in use, and pharmaceutical technologists wanting to update their knowledge of the methods of manufacture.

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.

Proteins are the cell's workers, their messengers and overseers. In these roles, proteins specifically bind small molecules, nucleic acid and other protein partners. Cellular systems are closely regulated and biologically significant changes in populations of particular protein complexes correspond to very small variations of their thermodynamics or kinetics of reaction. Interfering with the interactions of proteins is the dominant strategy in the development of new pharmaceuticals. Protein Ligand Interactions: Methods and Applications, Second Edition provides a complete introduction to common and emerging procedures for characterizing the interactions of individual proteins. From the initial discovery of natural substrates or potential drug leads, to the detailed quantitative understanding of the mechanism of interaction, all stages of the research process are covered with a focus on those techniques that are, or are anticipated to become, widely accessible and performable with mainstream commercial instrumentation. Written in the highly successful Methods in Molecular Biology series format, chapters contain introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and accessible, Protein Ligand Interactions: Methods and Applications, Second Edition serves as an ideal guide for researchers new to the field of biophysical characterization of protein interactions - whether they are beginning graduate students or experts in allied areas of molecular cell biology, microbiology, pharmacology, medicinal chemistry or structural biology.

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 book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

A comprehensive overview of the current research on inflammation and immunopharmacology, with particular attention to the use of anti-inflammatory drugs, this book discusses future trends in this area of pharmacological research. It addresses an audience with basic knowledge in the inflammatory process, immune system and pharmacology. The book meets the needs of graduate students, junior and senior researchers and is useful as a source of the most current information for those already working in these fields.

This book covers nanotechnology based approaches for improving the therapeutic efficacy of natural products. It critically explores lipid nanoarchitectonics, inorganic particles and nanoemulsion based tools for delivering them. With its chapters from eminent experts working in this discipline, it is ideal for researchers and professionals working in the area.

The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

This third edition volume expands on the previous editions both by presenting more detailed protocols for the techniques described in the first and second editions of High Throughput Screening: Methods and Protocols and by covering important new procedures. The first chapter of this book provides an overview of important assay development techniques, while the rest of the chapters detail how to develop and execute screens at whatever throughput the user needs. Some chapter examples are: structure-based virtual screening, high throughput screening using mass spectrometry, identification of state-dependent blockers for voltage gated calcium channels, bioluminescence resonance energy transfer platform to monitor protein-protein interactions in live cells, high throughput flow cytometry, and application of imaging-based assays in microplate formats for high content screening. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting edge and thorough, High Throughput Screening: Methods and Protocols, Third Edition, is a valuable resource for anyone who is interested in HTS research.

3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul's research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Alternative medicine: Herbal drugs and their critical appraisal - Part II.- Virus population dynamics, fitness variations and the control of viral disease: an update.- Applications of yeast in drug discovery.- Sympathetic nervous system and experimental diabetes: role of adrenal medullary hormones.- From outer to inner space: Traveling along a scientific career from astrochemistry to drug research.- Index Vol. 57.- Index of titles, Vol. 1-57.- Author and paper index, Vol. 1-57.

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.

This authoritative volume focuses on emerging technologies in cancer nano medicine, characterized by their multi-functionality and potential to address simultaneously diverse issues of clinical relevance in the treatment of cancer. The book consists of sixteen chapters divided into six sections: 1) Biological Barriers in Cancer; 2) Tumor Targeting; 3) Targeting the Immune System; 4) Gene Therapy; 5) Nano theranostics and 6) Translational Aspects of Nano-Oncologicals. The volume starts with an introduction describing the biological barriers associated with cancer therapy and highlighting ways to overcome such barriers through the use of nanotechnology. This is followed by an analysis of the two major targeting strategies currently under investigation in cancer therapy: namely, the targeting of cancer cells and the targeting of the immune system. In the first case, the book presents liposomal and polymer-based therapies, including photodynamic approaches. In the second case, it analyzes in detail the possibility of either improving the efficiency of the immune system toward preventing cancer progression (cancer immunomodulation) or generating responses against specific cancer antigens (cancer vaccines).

Beyond these targeting options, "Nano-Oncologicals: New Targeting and Delivery Approaches" presents the most recent technological advances in the area of nucleic acid-based therapies, along with those in the area of theranostics, where the design of multifunctional nano carriers becomes vital. Following the study of the most promising nanotechnologies around the development of nano-oncologicals, the book ends with an overview of regulatory and toxicological issues, which are critical in their translational pathway, and the presentation of a nucleic acid-based therapy case-study. This book is an important resource for scientists interested in the design and development of anticancer nanotechnologies and also to those aiming to push their technology through clinical development.

This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)-including its regulations and registration procedures-and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall, this book offers guidance for Western companies aspiring to expand into China's pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues.

This series was founded in 1959, and its focus has shifted from medicinal chemistry to a much wider scope. It now encompasses all fields concerned with the development of therapeutic drugs and the elucidation of their mechanisms of action, reflecting the increasingly complex nature of modern drugs research. Invited authors write reviews on the following fields: biology, chemistry, biochemistry, physiology, immunology, pharmacy, toxicology, pharmacology, and clinical aspects. The books are linked by indexes in each volume, forming an almost encyclopaedic work.

This book highlights the advances in essential oil research, from the plant physiology perspective to large-scale production, including bioanalytical methods and industrial applications. The book is divided into 4 sections. The first one is focused on essential oil composition and why plants produce these compounds that have been used by humans since ancient times. Part 2 presents an update on the use of essential oils in various areas, including food and pharma industries as well as agriculture. In part 3 readers will find new trends in bioanalytical methods. Lastly, part 4 presents a number of approaches to increase essential oil production, such as in vitro and hairy root culture, metabolic engineering and biotechnology. Altogether, this volume offers a comprehensive look at what researchers have been doing over the last years to better understand these compounds and how to explore them for the benefit of the society.

This edited book comprises of eight chapters dealing on various aspects of pharmaceutical technology for delivery of natural products. Book chapters deal with the solubility and bioavailability enhancement technologies for natural products. Emphasis has also been given on the significance of delivery strategies for improving the therapeutic efficacy of paclitaxel, galantamine and tea constituents.

Fluorine chemistry is an expanding area of research that is attracting international interest, due to the impact of fluorine in drug discovery and in clinical and molecular imaging (e.g. PET, MRI). Many researchers and academics are entering this area of research, while scientists in industrial and clinical environments are also indirectly exposed to fluorine chemistry through the use of fluorinated compounds for imaging.This book provides an overview of the impact that fluorine has made in the life sciences. In the first section, the emphasis is on how fluorine substitution of amino acids, peptides, nucleobases and carbohydrates can provide invaluable information at a molecular level. The following chapters provide answers to the key questions posed on the importance of fluorine in drug discovery and clinical applications. For examples, the reader will discover how fluorine has found its place as a key element improving drug efficacy, with reference to some of the best-selling drugs on the market. Finally, a thorough review on the design, synthesis and use of 18F-radiotracers for positron emission tomography is provided, and this is complemented with a discussion on how 19F NMR has advanced molecular and clinical imaging.

This book reviews the current strategies and challenges for the treatment of bacterial, fungal, parasitic and viral infectious diseases in developing countries. Contributing authors present expert analysis on the transmission, epidemiology, bacteriology, pathogenesis and treatment of Neglected Tropical Bacterial Diseases such as Leprosy, Buruli ulcer, and Trachoma. Particular attention is also given to current antifungal agents, their spectrum of activity, mode of action, limitations, and current challenges in antifungal therapy. The authors explore the medicinal chemistry efforts that gave rise to currently launched drugs and new anti-HIV agents, and they also highlight the latest vaccine and drug developments in the clinical management of the Ebola Virus Disease, ignited by the 2014-2016 outbreak. This work has an interdisciplinary appeal and will engage scholars and professionals in the burden of communicable diseases.

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

This second edition details some of the recent trends in HCS/HCA/HCI. New and updated chapters guide readers through methods that utilize reagents and kits that have been developed to measure cells and subpopulation classifications, control measures, overviews of the data handling issues associated with HCS/HCA/HCI, and methods to implement more complex phenotypic models. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, High Content Screening and Analysis-The Ideal Format for Phenotypic Screening: A Powerful Approach to Systems Cell Biology and Drug Discovery, Second Edition aims to ensure successful results in the further study of this vital field.

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.

This second edition book explores breakthrough technologies in the field of drug target identification and validation. The volume emphasizes particularly revolutionary technologies, such as CRISPR-related screening, "big data," and in silico approaches, as well as in vivo applications of CRISPR and best uses of animal models in drug development. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Fully updated and authoritative, Target Identification and Validation in Drug Discovery: Methods and Protocols, Second Edition is an ideal guide for molecular and cellular biologists, pharmacologists, pathologists, bioinformaticians, clinical researchers, or investigators, as well as experts in other fields that need a quick overview of these state-of-the-art technologies.

This book addresses the highly relevant and complex subject of research on drugs from natural products, discussing the current hot topics in the field. It also provides a detailed overview of the strategies used to research and develop these drugs. Respected experts explore issues involved in the production chain and when looking for new medicinal agents, including aspects such as therapeutic potential, functional foods, ethnopharmacology, metabolomics, virtual screening and regulatory scenarios. Further, the book describes strategic methods of isolation and characterization of active principles, biological assays, biotechnology of plants, synthesis, clinical trials and the use of tools to identity active principles.