This book deals with the recent advances in DNA-Encoded Library (DEL) technology that has emerged as an alternative to high throughput screening (HTS) over the last decade and has been heralded as a "disruptive" technology for drug discovery. The book aims to provide a comprehensive overview of all of the major components of the DEL process from conception to bench execution and clinical investigations. The contributions from experts in the field combine different perspectives from academia and industry. The book will be of interest to researchers in the drug discovery field as well as to graduate students and scholars who are interested in this rapidly improving technology.

A collection of information on the use of color additives in the food, cosmetic and medical industries. This Third Edition documents important recent developments such as newly listed products, delisted products, modernized specifications and improved analytical technology, new manufacturers and suppliers. A general background of color additives is given including their history, regulation, areas of use and purity requirements.

This volume takes an in-depth look at the potential pharmacological applications of 11 important antidiabetic plants, examining their antihyperglycemic, hypoglycemic, and anti-lipidemic properties along with current genome editing research perspectives. Plant natural products, or phytoconstituents, are promising candidates for antidiabetic pharmacological actions. The phytoconstituents, such as i' avonoids, terpenoids, saponins, carotenoids, alkaloids and glycosides, play vital roles in the current and future potent antidiabetic drug development programs Each chapter reviews a particular plant with antidiabetic properties, explaining the therapeutic aspects, its active antidiabetic compounds, and relevant genome editing technology. The specific plants discussed include Azadirachta indica (commonly known as neem, nimtree or Indian lilac), Gymnema sylvestre (commonly called gymnema, Australian cowplant, and Periploca of the woods), Syzygium cumini (commonly known as Malabar plum, Java plum, black plum, jamun or jambolana), Ceylon cinnamon (or true cinnamon, as opposed to cassia cinnamon), insulin plant (or Costus pictus), Trigonella foenum-graecum (better known as fenugreek), Mulberry, Nigella sativa L. (black caraway, also known as black cumin, nigella, kalojeera, kalonji or kalanji), Aegle marmelos (L.) (commonly known as bael (or bili or bhel), also Bengal quince, golden apple, Japanese bitter orange, stone apple or wood apple), Ficus benghalensis (the banyan, banyan fig and Indian banyan), and of course, garlic (Allium sativum). Antidiabetic Plants for Drug Discovery: Pharmacology, Secondary Metabolite Profiling, and Ingredients with Insulin Mimetic Activity will serve as a valuable source of information for students, drug researchers, medical practitioners, diabetic patients, and many others in the effort to gain understand of how these plant drug molecules can help fight diabetes.

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.

The purpose of this book is to highlight some of latest developments and applications of CRISPR, RNA, and DNA to treat diseases ranging from cancers to cardiovascular and degenerative disorders. It also features innovations of the delivery methods for nucleic acids ranging from nanodevices made from DNA and pseudo amino acids to viral vectors. This is an ideal book for academics, clinicians, and students interested in gene therapy.

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 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.

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).

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.

This collection explores detailed experimental protocols necessary for setting up a variety of in vitro cytochrome P450 (CYP) assays that are vital in selecting drug candidates in a drug discovery pipeline. Major factors affecting drug metabolism include CYP expression levels, kinetic parameters for individual CYP enzymes, CYP inhibition and induction, time-dependent inhibition (TDI), CYP stability, non-CYP stability, UDP-glucuronosyltransferases (UGT) stability, excretion mechanisms, and drug-drug interactions (DDI), all addressed in this volume. Written for the Methods in Pharmacology and Toxicology series, chapters include helpful background information on the in vitro assay, a list of all the materials, reagents, and equipment necessary to carry out the assay, a step-by-step protocol, notes containing common and unexpected experimental problems in the assay, as well as references containing important supplementary reading. Authoritative and practical, Cytochrome P450: In Vitro Methods and Protocols serves as a key guide for researchers in the area of discovery and development of new medicines.

This volume provides an overview of the biochemical characterization, structure-function studies, proteomics, bioinformatics, molecular biology, transcriptomics and genomics of various spider species. The book also covers our current knowledge of venom components, toxins and their modes of action. The first section of Spider Venom includes contributions regarding the wide diversity of spider venom components and depicts some of their biological effects (antimicrobial, ion channel modulators, insecticides, this includes peptide and non-peptide toxins), and emphasizes spiders of public health importance. The second section covers transcriptomes, proteomes (and peptidomics), bioinformatics and molecular dynamics. The last section describes antimicrobial, insecticidal toxins, envenomation and the medical potential of spider venoms. Spider venoms are a great and extensive source of bioactive compounds, and as such form a boundless and bountiful area awaiting discovery. It is by virtue of dedicated scientists that new toxins are discovered and that new insights arise, leading the way towards the investigation of their pharmacological effects, and hopefully, as a consequence, arriving at the discovery of venom components as new drug candidates.

Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/ or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.� Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of combination product regulations, guidance, considerations and best practices. This handbook: • Brings clarity of understanding for combination products guidance and regulations • Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market • Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

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.

This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol (R), and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.

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.

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.

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.

Quantitative Molecular Pharmacology and Informatics in Drug Discovery combines pharmacology, genetics and statistics to provide a complete guide to the modern drug discovery process. The book discusses the pharmacology of drug testing and provides a detailed description of the statistical methods used to analyze the resulting data. Application of genetic and genomic tools for identification of biological targets is reviewed in the context of drug discovery projects.
Covering both the theoretical principles upon which the techniques are based and the practicalities of drug discovery, this informative guide:

• outlines in step-by-step detail the advantages and disadvantages of each technology and approach and links these to the type of chemical target being sought after in the drug discovery process; and,
• provides excellent demonstrations of how to use powerful pharmacological and statistical tools to optimize high-throughput screening assays.

The applications of nanoparticulate drug delivery have gained significant attention in cancer diagnosis and treatment. Owing to their unique features and design, nanomedicines have made remarkable progress in eliminating dreadful tumors. Research in cancer nanomedicine spans multitudes of drug-delivery systems that include high tumor-targeting ability, sensitivity toward tumor microenvironments, and improved efficacy. Various nanocarriers have been developed and approved for anti-tumor drug targeting. These nanocarriers, such as liposomes, micelles, nanotubes, dendrimers, and peptides, offer several advantages including high selectivity, multifunctionality, specificity, biocompatibility, and precise control of drug release. This book provides complete information about each aspect of nanomaterials and nanotherapeutics, including synthesis, analysis, disease diagnosis, mechanistic insight, targeted drug delivery, and clinical implications in a concise and informative way. It presents simple and reader-friendly representations of the mechanisms of action of nanomaterials on cellular targets and highlights the challenges in targeted drug delivery with ongoing chemotherapeutic drugs.

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

Drug-drug interactions (DDIs) occur when a patient is exposed simultaneously to multiple pharmaceuticals, which can result in variations in drug response of the co-administered drugs. Using illustrative case studies and examples, Drug-Drug Interactions for Therapeutic Biologics focuses on the theoretical and practical aspects of DDIs assessments for therapeutic biologics in drug development. The book addresses the complex nature of biologic drug development and DDIs, which are very different from more traditional small molecule drugs, to help readers solve problems of preclinical pharmacology, toxicology, and model-based approaches for biologic drug development and the risk of drug-drug interactions.