This book is a comprehensive review of thrombin, especially as regulatory protease. The ready availability of highly purified thrombin has stimulated rapid advances in the cell biology of this important macromolecule. The text focuses on research findings from the discovery of thrombin by Andrew Buchanan in 1842 to the present. A substantial amount of this work was conducted by the author and his colleagues. His work on the purification of thrombin was seminal to much subsequent work on thrombin. This volume provides a framework for future studies now made possible by the discovery of the importance of exosites in the physiology of thrombin function. The current work describes the process of the development of an oral inhibitor of thrombin used in the prevention of thrombosis. Key Features Reviews the history of Thrombin (Fibrin Ferment) Documents the relation of protein engineering and chemical modification in the study of thrombin Summarizes the interaction of thrombin with fibrinogen and fibrin Outlines the role of exosites in thrombin function Describes the development of an oral inhibitor for thrombin

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book's balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

1. Provides hands on information on the current regulatory regulations working in the field of nutraceutical and dietary supplements 2. Gives explicit information regarding the recent evidenced-based knowledge on different stages of clinical trials of nutraceuticals and dietary supplements on various diseases. 3. Includes case studies in different disease conditions for better understanding of nutraceuticals and dietary supplements. 4. Discusses exclusive comparison with generic products which would establish a wide platform for acceptance of highly economical and ostentatious nutraceuticals.

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

This work presents an up-to-date account of some of the fundamental aspects of liquid-liquid extraction technology together with an account of extraction processes in a number of important industries. The work is divided into two parts. Volume 1 is concerned with the thermodynamics of phase equilibria; mass transfer in liquid-liquid systems, including the complicating role of interfacial turbulence; behavior of liquid-liquid dispersions; and the selection and design of countercurrent contactors for particular applications. Volume 2 gives an account of the process chemistry and associated extraction operations in a number of industries of current interest. New extraction techniques have been developed in recent years for specific applications and these are illustrated with reference to the hydrometallurgical, nuclear, pharmaceutical and food industries.

There is a great deal of contemporary interest in this topic and given this context, it is surprising that there are few texts around that cover this area. I think the proposal is perfectly placed to address this gap in the available literature in terms of an accessible ‘one-stop shop’ which researchers and scientists value as a broad overview of the contemporary literature and evidence-base. This book will interest practitioners and researchers in the food science and nutrition fields, and possibly others with an interest in the interaction between diet and health. There have been considerable advances in scientific techniques in the last few decades and these have been used to examine the composition and applications of traditional cures. Modern science has also seen the investigation of herbs, spices, and botanicals beyond their traditional usage. The evidence-based approach that the Editors propose is relatively rare for this type of topic. I think the market is already established for a book of this kind, it’s simply that there isn’t currently a book available to tap this market. I would believe this book would fulfill that role admirably.

The microneedle field has been expanding exponentially with innovative designs and various applications, thus capturing the interest of academic industry and regulatory sectors. Microneedles: The Future of Drug Delivery equips readers with a comprehensive understanding of microneedles; from percutaneous absorption to microneedles production, characterization, applications in drug delivery and diagnosis, to practical perspectives on the development, manufacturing, regulatory issues, and commercialization of microneedles. This book is written by a single author and thus provides complex information in a simple, elegant and cohesive style. The book is intended for graduate students, researchers, scientists and engineers working in the pharmaceutical, medical, cosmeceutical, and biotechnology industry.

The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.

Nanomaterials is an encouraging field for scientists and researchers due to its numerous applications in different fields such as medicine, energy, pharmaceutical, environmental science, agricultural food science and technology. Researchers are shifting towards the synthesis of nanoparticles using various plant systems.

This up-to-date reference book discusses the synthesis, production, and application of various microbial enzymes and metabolites for health. Microorganisms like bacteria (lactic acid bacteria, Bacillus species), yeasts, and filamentous fungi have been globally exploited for their biotechnological applications. This book discusses ways to use them commercially. Chapters include the production of fibrinolytic enzymes, microbial lipases, bacteriocin production by lactic acid bacteria, and bioactives produced. It also covers microbial synthesis of alkaloids, terpenoids, and steroids. The book is useful for researchers, academicians, and industry experts in microbiology and biotechnology.

This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an underlying cohort or target population of interest. This enables various extended designs to be introduced and analysed with a similar approach: extreme sampling on the outcome (extreme case-control design) or on the exposure (exposure-enriched, exposure-density, countermatched), designs that re-use prior controls and augmentation sampling designs. Further extensions exploit aggregate data for efficient cluster sampling, accommodate time-varying exposures and combine matched and unmatched controls. Self-controlled designs, including case-crossover, self-controlled case series and exposure-crossover, are also presented. The test-negative design for vaccine studies and the use of negative controls for bias assessment are introduced and discussed. This book is intended for graduate students in biostatistics, epidemiology and related disciplines, or for health researchers and data analysts interested in extending their knowledge of study design and data analysis skills. This book Bridges the gap between epidemiology and the more mathematically oriented biostatistics books. Assembles the wealth of epidemiological knowledge about observational study designs that is scattered over several decades of scientific publications. Illustrates the performance of methods in real research applications. Provides guidelines for implementation in standard software packages (Stata, R). Includes numerous exercises, covering simple mathematical proofs, consideration of proposed or published designs, and practical data analysis.

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

A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).

The Textbook of Ion Channels is a set of three volumes that provides 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 II starts with ion channel taxonomy and features coverage of major ion channel families and describes the physiological role, structural components, gating mechanisms and biophysics, permeation and selectivity, regulation, pharmacology and roles in disease mechanisms. Channels in this volume include voltage-activated sodium, calcium and potassium channels, inward-rectifier and two-pore domain potassium channels, calcium-activated potassium channels, cyclic-nucleotide gated channels, pacemaker ion channels, chloride channels, the ligand-gated receptors activated by acetylcholine, glutamate, 5-HT3, GABA and glycine, acid-sensing channels, P2X receptors, TRP channels, store-operated channels, pressure-activated piezo channels, ryanodine receptors and proton channels. 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.

The Textbook of Ion Channels is a set of three volumes that provides 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 III includes coverage of key ion channel regulators and their mechanisms, the role of ion channels working in concert in selected physiological systems, and examples of ion channel mutations and dysfunction in a selection of diseases. Chapters on ion channel regulation include splice variants, calcium-calmodulin regulation, regulation by G-proteins, and lipids. A selection of ion channels in physiological systems includes ion channels of the heart, ion channels in immune cells and their role in pancreatic beta cells and regulation of insulin secretion, and the role of channels in sperm and eggs. While disease mechanisms are integrated into the chapters of Volume II, Volume III offers special consideration of ion channels in epilepsy, cystic fibrosis, and pain syndromes. 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.

Counterfeit drugs continue to infiltrate the drug market in the United States, causing illness and death. This book addresses this issue and examines the recent trends in drug counterfeiting over the past 5-10 years. The text shows perspectives from crime lab and toxicology lab personnel and academic researchers, and includes topics such as a history of cases and issues with counterfeit drugs, trends observed in forensic labs, instrumental methods and approaches used in detecting counterfeit medicines, and policy approaches for controlling counterfeit drugs. There is a focus on ways to reduce counterfeit drugs in the market, to help improve the health and safety of people all over the world. Features : Focuses on recent (5-10) year trends in counterfeit drugs and analysis. Shows perspectives from crime lab and toxicology lab personnel and academic researchers. Focuses on drugs seized by law enforcement and approaches to reducing counterfeit medicine in the market. Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue. Emphasizes the global impact of illegal medicines.

Worldwide interest in Ayurveda is on the rise, ever since the World Health Organization adopted the Alma Ata Declaration in 1978. Ayurveda is increasingly being adopted and many phytotherapy schools in Europe and the Americas teach Ayurveda as a wellness system. Considering the prominent position that Aṣṭ�ṅgahṛdaya occupies in Ayurveda, a scientific synopsis of this masterpiece is now presented before the world of Ayurveda. In eight comprehensive chapters, Aṣṭ�ṅgahṛdaya: A Scientific Synopsis of the Classic Ayurveda Text presents a lucid summary of the teachings of V�gbhaṭa. Ayurvedic view of the human body, basic principles of Ayurveda, surgical armamentarium, diagnosis and treatment of diseases, herbs and other medicinal substances used in the preparation of various dosage forms, ayurvedic pharmaceutialcs, ayurvedic approach to food fortification, salient features of Aṣṭ�ṅgahṛdaya and a roadmap for the future are among the topics discussed. Key Features: Presents the ayurvedic view of conception and the human body. Discusses aspects of ayurvedic pharmaceuticals. Examines diagnosis of diseases, lines of treatment, prognosis of diseases, signs of imminent death, management of mishaps and treatment of new diseases. The voluminous information pertaining to the subjects of the various chapters is presented in the form of many tables for ready reference and quick survey. This book provides a helping hand to those interested in rediscovering the teachings of V�gbhaṭa and is a great resource for researchers of medicine, traditional and alternative medicine, pharmacology and drug discovery.

An outstanding resource which enables readers to better understand the conditions that led to these Nobel Prize amazing discoveries To an extent the roots of organic chemistry have been forgotten or lost and this set of volumes bridges the gap Unique set of volumes, no other book publication in the field competes and only press releases announcing the prizes from recent years exist "More than any other branch of chemistry, organic chemists look to history, so the readers will certainly enjoy this compilation " Appeals to a diverse audience including upcoming as well as modern practicing chemists, and provides the historical context of these discoveries

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.

This is the first resource to provide researchers in academia and industry with an urgently needed update on drug intervention against trypanosomatides. As such, it
covers every aspect of the topic from basic research findings, via current treatments to translational approaches in drug development and includes both human and livestock diseases. The outstanding editor and contributor team reads like a Who's Who of the field, thus guaranteeing the outstanding quality of this ready reference.

A comprehensive review of the challenges that exist in patient accessibility to advanced therapy medicinal products (ATMPs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialisation. Specfically, we investigated how COVID-19 has impacted the RMs industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-markers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines. Features : Regenerative medicine (RM) is an emerging interdisciplinary field aiming to replace or regenerate human cells, tissues, or organs in order to restore normal functions. Regenerative medicine holds the promise of revolutionising treatment in the 21st century. RMs bring new hope for some previously untreatable diseases, as well as holding promise for the treatment of common chronic diseases. Rapid advancements in biotechnology and improved understanding of disease pathophysiology have attracted tremendous interests in the development of RMs. Discusses the high cost of RMs which may challenge the sustainability of healthcare insurers (public and private).

This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.