Although batch processing has existed for a long time, designing these processes and unit operations has been considered an onerous task that required computational efforts. Design of these processes is made more complex because of the time dependent nature of the process and the allowable flexibility. More often than not, every unit encounters optimal control problems. Therefore, traditional design books have not covered batch processing in detail. Filling this void, Batch Processing: Modeling and Design describes various unit operations in batch and bio-processing as well as design methods for these units. Topics include: Batch distillation operating modes and configurations Batch absorption operations based on the solubility difference Batch adsorption based on differential affinity of various soluble molecules to solid absorbents Batch chromatography for measuring a wide variety of thermodynamic, kinetic, and physico-chemical properties Batch crystallization where a phase is used to find the supersaturation at which point material crystallizes Batch drying that stresses the phase diagram of water to describe this operation Batch filtration using a porous medium or screen to separate solids from liquids Batch centrifugation where centrifugal force is used for separation Batch processes are widely used in pharmaceutical, food, and specialty chemicals where high value, low volume products are manufactured. Recent developments in bio-based manufacturing also favor batch processes because feed variations can be easily handled in batch processes. Further, the emerging area of nanomaterials manufacturing currently uses batch processes as they are low volume, high energy intensive processes. With examples, case studies, and more than 100 homework problems, this book describes the unit operations in batch and bioprocessing and gives students a thorough grounding in the numerical methods necessary to solve these design problems.

Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research. Interpreting lessons learned from the clinical trials of first generation drugs, the book evaluates the technology as a whole and offers new directions and avenues of research and development.

Divided into five parts, the book begins with a thorough introduction to the mechanism of antisense drug action including the RNase H mechanism, small RNA silencing pathways, and the potential therapeutics of splice switching oligonucleotides. Leading researchers demonstrate the basics of oligonucleotide therapeutics in part two by delineating medicinal chemistry, pharmacokinetics, and delivery routes such as liposomal formulations for nucleic acid delivery. Part three details hybridization based drugs and considers the dramatic advances represented by 2' methoxyethyl chimeric antisense inhibitors and duplex RNA drugs. Other chemical classes of drugs and mechanisms of action are described in part four with further discussions on improving the second generation antisense drugs. The final part delves deeply into therapeutic applications. Contributing authors examine the potential of antisense drugs for the alleviation of cardiovascular diseases, metabolic diseases, inflammatory diseases, cancer, neurological disorders, and immune modulation.

Presenting a highly detailed, lucid discussion of the remarkable advances in the field, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition provides theplatform for researchers to continue to aggressively pursue the great opportunity represented by this exciting technology.

This fully updated new edition presents organic reaction mechanism questions, carefully selected from the primary chemical literature, to understand how reactants are transformed into products. The author explains step-by-step solutions to all problems with appropriate contextual comments explaining the rationale and reasoning underlying each step, and identifying the underlying principles involved in each question. In the process the reader gains a better understanding of the fundamental principles of organic chemistry and how to become proficient in using the Lewis acid/Lewis base concept to complete organic reactions without resorting to memorization. Features : The questions are graded in difficulty with Part A containing questions aimed at students taking the sophomore-level organic chemistry class, while part B contains questions of somewhat greater difficulty suitable for students taking an honors course in organic chemistry or a beginning graduate course. Detailed answers are provided to all questions so students can check their answers and important points are highlighted in each answer. Special emphasis has been placed on the selection of questions to ensure that each question illustrates one or more fundamental principles of organic chemistry. Interspersed throughout the book are minireviews that cover the material pertaining to a particular topic. The specific literature references corresponding to each question are included and students can look up those references for more contextual information. Includes a large number of carefully-selected mechanism questions and step-by-step solutions, including explanatory comments

This is the first book that comprehensively and systematically describes the new technology of hydrophilic interaction liquid chromatography (HILIC). Hydrophilic interaction chromatography is a separation technique suitable for polar and hydrophilic compounds and orthogonal to reversed phase liquid chromatography. From small organic molecules to proteins, the text explores the many applications of HILIC in the analytical field. Winner of the President's Award for Excellence, the author explains how HILIC can significantly improve analytical throughput by shortening sample preparation procedure, which is one of the bottlenecks for drug discovery and development in the pharmaceutical industry.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Reviews phyto-actives and their targeted action in the management of various cancers Looks at the use of phytochemical-based nano-cosmeceuticals for beautification Explores emerging concepts of vitamins and nanocarriers as nutraceuticals Discusses the advantages of bioactive-loaded nanomedicines over conventional phytotherapies

In this volume the authors promote, endorse and stimulate research in the vibrant field of biological inorganic chemistry. They provide an overview of metallodrugs which have been rationally designed to target specific biomolecules in the human body with a view to generating targeted drugs or prodrugs with widespread biomedical applications. The volume focuses on recent trends and advances in relation to targeted metallodrugs as anti-cancer, anti-microbial and anti-viral agents with an emphasis on their design, development and mode of action. It also include recent advances in the use of nanoparticles and nanoclusters as important chaperones to deliver metallodrugs to their sites of action.

The six years that have passed since the publication of the first edition have brought significant advances in both biofilm research and biofilm engineering, which have matured to the extent that biofilm-based technologies are now being designed and implemented. As a result, many chapters have been updated and expanded with the addition of sections reflecting changes in the status quo in biofilm research and engineering. Emphasizing process analysis, engineering systems, biofilm applications, and mathematical modeling, Fundamentals of Biofilm Research, Second Edition provides the tools to unify and advance biofilm research as a whole. Retaining the goals of the first edition, this second edition serves as: A compendium of knowledge about biofilms and biofilm processes A set of instructions for designing and conducting biofilm experiments A set of instructions for making and using various tools useful in biofilm research A set of computational procedures useful in interpreting results of biofilm research A set of instructions for using the model of stratified biofilms for data interpretation, analysis, and biofilm activity prediction

There is a clear need for innovative technologies to improve the delivery of therapeutic and diagnostic agents in the body. Recent breakthroughs in nanomedicine are now making it possible to deliver drugs and therapeutic proteins to local areas of disease or tumors to maximize clinical benefit while limiting unwanted side effects. Nanomedicine in Drug Delivery gives an overview of aspects of nanomedicine to help readers design and develop novel drug delivery systems and devices that build on nanoscale technologies. Featuring contributions by leading researchers from around the world, the book examines: The integration of nanoparticles with therapeutic agents The synthesis and characterization of nanoencapsulated drug particles Targeted pulmonary nanomedicine delivery using inhalation aerosols The use of biological systems-bacteria, cells, viruses, and virus-like particles-as carriers to deliver nanoparticles Nanodermatology and the role of nanotechnology in the diagnosis and treatment of skin disease Nanoparticles for the delivery of small molecules, such as for gene and vaccine delivery The use of nanotechnologies to modulate and modify wound healing Nanoparticles in bioimaging, including magnetic resonance, computed tomography, and molecular imaging Nanoparticles to enhance the efficiency of existing anticancer drugs The development of nanoparticle formulations Nanoparticles for ocular drug delivery Nanoparticle toxicity, including routes of exposure and mechanisms of toxicity The use of animal and cellular models in nanoparticles safety studies With its practical focus on the design, synthesis, and application of nanomedicine in drug delivery, this book is a valuable resource for clinical researchers and anyone working to tackle the challenges of delivering drugs in a more targeted and efficient manner. It explores a wide range of promising approaches for the diagnosis and treatment of diseases using cutting-edge nanotechnologies.

The Textbook of Ion Channels is a set of three volumes providing a wide-ranging reference source on ion channels for students, instructors, and researchers. Ion channels are membrane proteins that control the electrical properties of neurons and cardiac cells, mediate the detection and response to sensory stimuli like light, sound, odor, and taste, and regulate the response to physical stimuli like temperature and pressure. In non-excitable tissues, ion channels are instrumental for the regulation of basic salt balance that is critical for homeostasis. Ion channels are located at the surface membrane of cells, giving them the unique ability to communicate with the environment, as well as the membrane of intracellular organelles, allowing them to regulate internal homeostasis. Ion channels are fundamentally important for human health and diseases, and are important targets for pharmaceuticals in mental illness, heart disease, anesthesia, pain and other clinical applications. The modern methods used in their study are powerful and diverse, ranging from single ion-channel measurement techniques to models of ion channel diseases in animals, and human clinical trials for ion channel drugs. Volume I, Part 1 covers fundamental topics such as the basic principles of ion permeation and selectivity, voltage-dependent, ligand-dependent and mechano-dependent ion channel activation mechanisms, the mechanisms for ion channel desensitization and inactivation and basic ion channel pharmacology and inhibition. Volume I, Part 2 aims to offer a practical guide of cardinal methods for researching ion channels, including heterologous expression and voltage-clamp and patch-clamp electrophysiology, isolation of native currents using patch-clamp, modelling ion channel gating, structures and its dynamics, crystallography and cryo- electron microscopy, fluorescence and paramagnetic resonance spectroscopy methods and genetics approaches in model organisms. All three volumes give the reader an introduction to fundamental concepts needed to understand the mechanism of ion channels, a guide to the technical aspects of ion channel research, offer a modern guide to the properties of major ion channel families, and include coverage of key examples of regulatory, physiological, and disease roles for ion channels.

Presents the latest developments on the interaction of metal complexes with nucleic acids, the building blocks of life. Bioinorganic chemistry is a highly interdisciplinary area of research and is of great interest to scientists working in the fields of coordination chemistry, biochemistry, supramolecular chemistry, nanotechnology, computational chemistry, and inorganic chemistry in general. Includes the latest research in DNA recognition by supramolecular metal complexes. Describes the applications of this exciting area of research in metal-nucleic acid chemistry.

Colloidal drug delivery systems present a range of therapeutic benefits in the treatment of a number of challenging conditions, allowing researchers to cross barriers that have previously prevented efficient treatment while offering improved and more targeted absorption. Summarizing recent research in the field, Colloids in Drug Delivery assembles the work of 65 of the world's leading colloid scientists who examine the full spectrum of this rapidly emerging science, from pure to applied, most of it drawn from their own experience and research. The book begins by examining the basics of surfactant and polymer surface activity and self-assembly, the various types of structures formed by such compounds, and their use in drug delivery and biotechnology. It examines the development of controlled and targeted delivery systems by utilizing the various properties of colloids before moving on to discuss various applications and fields of research. Topics discussed include: The use of hard, soft, and macromolecular colloidal drug delivery systems formed by surfactants, polymers, proteins, and lipids Recent advances in procolloidal systems, self-emulsifying drug delivery systems, and aerosol applications to pharmaceutical drug delivery Colloidal nanocarriers for imaging applications and the treatment of dental and periodontal diseases Classification and application of colloidal drug delivery systems in tumor targeting The use of colloids for improved nasal, ocular, vaginal, oral, buccal, gastrointestinal, and colon drug delivery Examining topics necessary to the critical evaluation of a drug candidate's potential for delivery, the book also describes the preparation, classification, interfacial activity, surface modifications and influence on particle characteristics, drug delivery, and drug targeting. Each chapter in this expansive volume explains why a particular system is used for the intended application, how it is made, and how it behaves. All those concerned with the research, development, and manufacture of drugs will find this a valuable reference, offering a wealth of research upon which they can build.

Offering step-by-step technical details, Liposome Technology, Third Edition, Three Volume Set provides comprehensive coverage of all aspects of liposome technology, including liposome preparation and analysis, entrapment of drugs and other materials into liposomes, and liposome interaction with the biological environment to be applied in the detection, therapy, or prevention of disease. The text offers critical discussions of the methodologies of each technology discussed so that readers can examine the benefits and limitations and compare it to other methods. This Third Edition features 55 chapters written by leading international experts. Because of the considerable progress in liposome related techniques and their application in therapy since the publication of the Second Edition in 1992, over half of the chapters are new to the edition, and the other chapters have been extensively updated. Liposome Technology, Third Edition, Three Volume Set is an ideal resource for pharmaceutical scientists, researchers, regulatory personnel, FDA personnel, and medicinal chemists working in this discipline.

Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods like electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices.

Research in the field of epilepsy will continue at a rapid pace, with the ultimate hope of curing many intractable epilepsy syndromes. Fully updated, this new edition is organized chronologically, from neonate through adolescence, and the handbook is the culmination of a group effort involving leading physicians and researchers whose contributions constitute a concise and practical reference for health professionals in training. Here the contributors review the recent flood of new information on the pathophysiology, genetics, and treatment of the various epilepsy syndromes and the volume is distilled into an easy-to-use guide. Fully updated text reviewing the latest research the pathophysiology, genetics, and treatment of the various epilepsy syndromes. Thorough, descriptions of the different syndromes commonly encountered in clinical practice across the pediatric range. Extensive resource section provided. Contributors describe why they chose each particular case, what they learned, and how it changed their practice. Access to a companion website, which offers digital graphics and videos on the topic

Building on the success of the previous editions, the Textbook of Drug Design and Discovery, Fifth Edition, has been thoroughly revised and updated to provide a complete source of information on all facets of drug design and discovery for students of chemistry, pharmacy, pharmacology, biochemistry, and medicine. The information is presented in an up-to-date review form with an underlying and fundamental focus on the educational aspects. Beginning with an introduction to drug design and discovery, the first eight chapters cover molecular recognition, ligand-based drug design, and biostructure-based drug design. The authors also discuss drug-like properties and decision making in medicinal chemistry, chemical biology, natural products in drug discovery, and in vivo imaging in drug discovery. The middle six chapters provide an overview of peptide and protein drug design, prodrugs in drug design and development, and enzyme inhibitors. The authors also go through receptors (structure, function, and pharmacology), ion channels (structure and function), and neurotransmitter transporters (structure, function, and drug binding). The following chapters address important neurotransmitter systems, GABA and glutamic acid receptors and transporter ligands, acetylcholine, histamine, dopamine and serotonin, and opioid and cannabinoid receptors. The book concludes with an examination of neglected diseases, anticancer agents, tyrosine kinase receptors, and antibiotics.

This fully updated second edition reflects the significant changes in process chemistry since the first edition and includes more common process issues such as safety, cost, robustness, and environmental impact. Some areas have made notable progress such as process safety, stereochemistry, new reagents and reagent surrogates. Forty years ago there were few process research and development activities in the pharmaceutical industry, partly due to the simplicity of drug molecules. With increasing structural complexity especially the introduction of chiral centers into drug molecules and stricter regulations, process R&D has become one of the critical departments for pharmaceutical companies. This unique volume now in its second edition is designed to provide readers with an unprecedented strategy and approach which will help chemists and graduate students develop chemical processes in an efficient manner Promotes an industrial mindset concerning safety and commercial viability when developing methods The author discusses development strategies with case studies and experimental procedures Focuses on mechanism-guided process development which provides readers with practical strategies and approaches Addresses more common process issues such as safety, cost, robustness, and environmental impact.

The Science and Business of Drug Discovery is written for those who want to learn about the biopharmaceutical industry and its products whatever their level of technical knowledge. Its aim is to demystify the jargon used in drug development, but in a way that avoids over simplification and the resulting loss of key information. Each of the twenty chapters is illustrated with figures and tables which clarify some of the more technical points being made. Also included is a drug discovery case history which draws the relevant material together into a single chapter. In recognizing that it is difficult to navigate through the many external resources dealing with drug development, the book has been written to guide the reader towards the most appropriate information sources, including those listed in the two appendices. The following topics are covered: Different types of drugs: from small molecules to stem cells Background to chemistry of small and large molecules Historical background to drug discovery, pharmacology and biotechnology The drug discovery pipeline: from target discovery to marketed medicine Commercial aspects of drug discovery Challenges to the biopharmaceutical industry and its responses Material of specific interest to technology transfer executives, recruiters and pharmaceutical translators

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

The volume sheds new light on role of gut dysbiosis in cancer and immunological diseases and their clinical manifestations. Contributions in the volume discuss about the gut microbiota as a therapeutic target and the role of probiotics in its management. The volume explores application of probiotics in the treatment of various cancers viz. colorectal, gastric, lung, and breast cancer and immunological diseases. The volume comprises of chapters from expert contributors organized into various important themes which include, introduction, relationship between gut microbiota and disease condition, mechanisms involved, clinical and in vivo status, conclusion and future directions. This is a highly informative and carefully presented book, providing recent and innovative insight for scholars and researchers with an interest in probiotics and its applications in cancer and immunological diseases.

This volume on applied pharmaceutical science and microbiology looks at the latest research on the applications of natural products for drug uses. It focuses on understanding how to apply the principles of novel green chemistry methods in the vital area of pharmaceuticals and covers the important aspects of green microbial technology in the pharmaceutical industry. Chapters include studies on the applications of natural products used in folk and regional medicines, such as for digestive problems, dermatological infections, respiratory diseases, vessel diseases, diarrhea and dysentery, ringworms, boils, fevers (antipyretic), skin and blood diseases, mouth sores, channel discharges, and even cancer. The volume also looks at medical benefit of microbial fermentation for the conservation of nutrients.