Epothilones have received unusual attention over the past ten years. They are novel antitumor drugs which very much like their predecessor paclitaxel (Taxol) act via microtubule stabilization. In comparison to paclitaxel and a number of alternative drugs with a similar mode of bioaction (e.g. laulimalide, eleutherobin, peluroside, discodermolide) the epothilones have significant advantages, above all very high activity in the nanomolar range and low susceptibility towards multidrug resistance. Epothilone B and several derivatives thereof are in phase I-III clinical trials; one of them (ixabepilone, BMS) is already on the market, others are supposed to appear on the market in the near future. All naturally occurring epothilones have been isolated from Sorangium cellulosum; their antitumor action is traced back to the stabilization of microtubules. In consequence, the formation of the mitototic spindle is prohibited and the cell undergoes apoptosis.

Organ Specific Drug Delivery and Targeting to the Lungs provides up to date information on the multidisciplinary field of particle engineering and drug delivery to the lungs, including advancements of nanotechnology. The text presents a unique, pragmatic focus with case studies, that help translate scientific understanding to practical implementation. In addition to highlighting the successful case studies, it also offers practical advice on watchouts, limitations, and 'bookend' boundaries involved in the stages of testing and development. Additional Features Include: Provides an account of particle engineering, discovery, biology, development, and delivery in relation with the advancements of nanotechnology, unlike any previous book. Brings together the leading experts and researchers in the field to critically assess and discuss various topics influencing drug delivery. Highlights the interplay of different scientific disciplines and the balance of requirements that are critical to molecule and product design. With the strategic focus on what matters during new product development, this book provides a guide to understanding and navigating new drug discovery and development for lung targets.

Core-Shell Nanostructures for Drug Delivery and Theranostics: Challenges, Strategies and Prospects for Novel Carrier Systems contains valuable chapters that deal with the fundamentals of nanotechnology for drug delivery, recent developments and research in core-shell nanoparticles for drug-delivery and theranostic applications, and the potential and applications of core-shell nanofiber. This book is a highly valuable resource for scientists interested in the design and development of innovative drug delivery systems, researchers and graduate/postdoctoral students engaged in biomaterials for drug delivery, and R&D managers in the biomaterials and pharmaceutical industry.

Chemical Sciences in Early Drug Discovery: Medicinal Chemistry 2.0 describes how new technologies and approaches can be used to improve the probability of success in fulfilling the perennial goal of finding and developing new drugs. Drawing on the author's extensive experience consulting and teaching in medicinal chemistry, the book outlines ways in which medicinal chemistry is widening its reach to meet modern demands, and how modern technologies and approaches are facilitating this growth into new fields. Supported by examples throughout, the book is a practical resource for organic-medicinal chemists, biological chemists and pharmacologists involved in drug discovery.

Key Features: 1. Describes the development of the randomized, controlled trial as the gold standard of proof. 2. Unravels the meaning of "randomized," "double-blind" and "p-values" in a simplified manner for students and clinicians. 3. Contains timeless information on how medical evidence can be understood.

Plant-based medicines and aromatics are increasingly in demand throughout the health sector globally, which involves their use not only for the treatment of diseases, but also as potential therapeutics standards for maintaining good health. Unlike modern medicine, herbal medicines derived from plants have several major advantages, including general absence of serious adverse side effects, long-lasting curative impact, and overall cost-effectiveness. Medicinal plants have become threatened due to their minuscule population size, narrow distribution area, habitat specificity, and destructive way of harvesting, only a few studies have been undertaken on their conservation, ecology and pharmacognosy.

This book explores efficient syntheses of indole alkaloids based on gold-catalyzed cascade cyclizations, presenting two strategies for total synthesis of these natural products based on gold-catalyzed reactions of conjugated diyne or ynamide. The book first describes the total and formal synthesis of dictyodendrins A-F based on direct construction of the pyrrolo[2,3-c]carbazole core using the gold-catalyzed annulation of azido-diynes and protected pyrrole. This synthetic strategy features late-stage functionalization of the pyrrolo[2,3-c]carbazole scaffold at several positions and allows diverse access to dictyodendrins and their derivatives. Secondly, the book discusses the formal synthesis of vindorosine based on the pyrrolo[2,3-d]carbazole construction using the gold-catalyzed cascade cyclization of ynamide. Importantly, the reaction using a chiral gold complex provides the optically active pyrrolo[2,3-d]carbazole. This strategy facilitates the rapid construction of the pyrrolocarbazole core structure of aspidosperma and related alkaloids, including vindorosine. These methodologies can accelerate the medicinal application of pyrrolocarbazole-type alkaloids and related compounds.

This book comprehensively reviews the state-of-the-art strategies developed for protein-protein interaction (PPI) inhibitors, and highlights the success stories in new drug discovery and development. Consisting of two parts with twelve chapters, it demonstrates the design strategies and case studies of small molecule PPI inhibitors. The first part discusses various discovery strategies for small molecule PPI inhibitors, such as high throughput screening, hot spot-based design, computational approaches, and fragment-based design. The second part presents recent advances in small molecule inhibitors, focusing on clinical candidates and new PPI targets. This book has broad appeal and is of significant interest to the pharmaceutical science and medicinal chemistry communities.

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.

Beer is made up of various bioactive substances containing antioxidants and specific ingredients with potentially beneficial effects on the human body if consumed in moderation. In the production process, the addition of hops, cereals, and malt leads to an increased content of naturally occurring antioxidant compounds in beer, mainly phenolic compounds. This book presents information on the history, compositional analysis, and brewing process of craft beers. It covers aspects of fruit fortification to different craft brewed beers and how it will enhance the nutritional composition, antioxidant properties, color and sensory attributes of beers. The alcohol industry continues to grow quickly worldwide, this book provides relevant research literature about the recent studies and experimentation about beers which will be helpful to students, researchers, industrialists, producers, and many others. The incorporation of fruits for the fortification of beers is a topic of interest resulting in the need for more innovative and effective methods and steps in the production of newer variants of beers.

The book provides a reference for years to come, written by world-renowned expert investigators studying sex differences, the role of sex hormones, the systems biology of sex, and the genetic contribution of sex chromosomes to metabolic homeostasis and diseases. In this volume, leaders of the pharmaceutical industry present their views on sex-specific drug discovery. Many of the authors presented at the Keystone Symposium on "Sex and gender factors affecting metabolic homeostasis, diabetes and obesity" to be held in March 2017 in Lake Tahoe, CA. This book will generate new knowledge and ideas on the importance of gender biology and medicine from a molecular standpoint to the population level and to provide the methods to study them. It is intended to be a catalyst leading to gender-specific treatments of metabolic diseases. There are fundamental aspects of metabolic homeostasis that are regulated differently in males and females, and influence both the development of diabetes and obesity and the response to pharmacological intervention. Still, most preclinical researchers avoid studying female rodents due to the added complexity of research plans. The consequence is a generation of data that risks being relevant to only half of the population. This is a timely moment to publish a book on sex differences in diseases as NIH leadership has asked scientists to consider sex as a biological variable in preclinical research, to ensure that women get the same benefit of medical research as men.

Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry ist das einzige Buch seiner Art, das sich an die schnell wachsende Gemeinschaft der PBPK-Anwender richtet und in klaren, pragnanten Worten die Grundlagen darstellt. Durch die Verbindung von Theorie und Praxis wird in diesem Werk das unglaubliche Potenzial der PBPK-Modellierung fur die Verbesserung der Entdeckung und Entwicklung von Arzneimitteln betrachtet. In der neuen Ausgabe wird der Schwerpunkt starker auf Anwendungen und relevante Fallstudien gelegt. Ausserdem gibt es eine begleitende Website mit Datensatzen, die viele der wichtigsten Entwicklungen im Bereich der PBPK-Modellierung und -Simulation seit der Veroeffentlichung der ersten Ausgabe im Jahr 2012 abbilden.

"Controlled Release in Oral Drug Delivery" provides focus on specific topics, complementing other books in the initial CRS series. Each chapter sets the context for the inventions described and describe the latitude that the inventions allow. In order to provide some similar look to each chapter, the coverage includes the historical overview, candidate drugs, factors influencing design and development, formulation and manufacturing and delivery system design. This volume was written along three main sections: the relevant anatomy and physiology, a discussion on candidates for oral drug delivery and the major three groups of controlled release systems: diffusion control (swelling and inert matrices); environmental control (pH sensitive coatings, time control, enzymatic control, pressure control) and finally lipidic systems.

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Key Features: 1. Presents unconventional waste treatment to increase biotic resource efficiency as against standard crop and forestry residues 2. Focuses on promoting sustainability concept within different kinds of waste biorefinery 3. Discusses various systems like microalgal, poultry and microbial refineries 4. Includes techno-economic analysis for waste streams in biofuel production 5. Covers topics like sewer mining, gas fermentation and food waste management

Explains theory and practical applications of nanomaterials as antiviral agents Reviews upscaling of nanomaterials from laboratory to fabrication stage Illustrates nanocurcumin, silver nanoparticles, and carbon nanoparticles for biomedical applications Highlights role of nanotechnology in effectively combating viral infections and pandemics Includes case studies of specific pharma companies

Key Features- Highlights recent advances in phytomedicine formulation development based on nanotechnology approaches, while also discussing the pharmacological property of Green synthesized ZnO particles focusing on the clinical perspective. Explores development of nanoparticles, synthesis techniques, characterization techniques, tissue engineering applications, biological applications, and multi-functional applications for cancer, inflammatory diseases, Alzheimer's disease and diabetes. Serves as a valuable guide for early career researchers, young scientists, academics and scientists working in various field like pharmaceutical, life sciences, Nano biotechnology about the applications of nanoparticles derived from plant sources.

This work presents a systematic review of traditional herbal medicine and their active compounds, as well as their mechanism of action in the prevention and treatment of diabetes and obesity. The side effects and safety of herbal-derived anti-diabetic and anti-obesity phytochemicals are detailed in depth, and the text has a strong focus on current and future trends in anti-diabetic medicinal plants. This unique and comprehensive text is the only current book on the market focusing exclusively on medicinal plants used to combat obesity and diabetes. An introductory chapter focuses on diabetes and obesity and introduces the major causes and main treatments of this increasing epidemic in modern society. Readers are then introduced to medicinal plants, including details on their therapeutic aspects, plus side effects and safety. Following chapters focus on anti-diabetic and anti-obesity medicinal plants, as well as phytogenic natural products in the treatment of each. The text closes by focusing on present and future trends and challenges in these medicinal plants. Anti-diabetes and Anti-obesity Medicinal Plants and Phytochemicals: Safety, Efficacy, and Action Mechanisms is a much-needed and truly original work, finally presenting in one place all the necessary information on medicinal plants used in conjunction with obesity and diabetes prevention.

Translational medicine addresses the gap between research and the clinical application of new discoveries. To efficiently deliver new drugs to care centers, a preclinical evaluation, both in vitro and in vivo, is required to ensure that the most active and least toxic compounds are selected as well as to predict clinical outcome. Antimicrobial nanomedicines have been shown to have higher specificity in their therapeutic targets and the ability to serve as adjuvants, increasing the effectiveness of pre-existing immune compounds. The design and development of new standardized protocols for evaluating antimicrobial nanomedicines is needed for both the industry and clinical laboratory. These protocols must aim to evaluate laboratory activity and present models of pharmacokinetic-pharmacodynamic and toxicokinetic behavior that predict absorption and distribution. Likewise, these protocols must follow a theranostics approach, be able to detect promising formulations, diagnose the infectious disease, and determine the correct treatment to implement a personalized therapeutic behavior. Given the possibilities that nanotechnology offers, not updating to new screening platforms is inadequate as it prevents the correct application of discoveries, increasing the effect of the valley of death between innovations and their use. This book is structured to discuss the fundamentals taken into account for the design of robust, reproducible and automatable evaluation platforms. These vital platforms should enable the discovery of new medicines with which to face antimicrobial resistance (RAM), one of the great problems of our time.

* Innovative clinical trial design * Regulatory approval * Real world evidence

This book, which is the third volume of Biomedical translational research, focuses on the fundamental role of biomedical research in developing new medicinal products. It emphasizes the importance of understanding biological and pathophysiological mechanisms underlying the disease to discover and develop new biological agents. The book uniquely explores the genomic computational integrative approach for drug repositioning. Further, it discusses the health benefits of nutraceuticals and their application in human diseases. Further, the book comprehensively reviews different computational approaches that employ GWAS data to guide drug repositioning. Finally, it summarizes the major challenges in drug development and the strategies for the rational design of the next generation more effective but less toxic therapeutic agents.

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.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed.This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions. Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Discusses siRNA, mRNA, and plasmid manufacturing. Describes the importance of supplier-sponsor synergies on the path to commercialization. Diverse audience with a large number of individuals in the core technologies and supportive practices.

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.