This book explains theoretical and technological aspects of amorphous drug formulations. It is intended for all those wishing to increase their knowledge in the field of amorphous pharmaceuticals. Conversion of crystalline material into the amorphous state, as described in this book, is a way to overcome limited water solubility of drug formulations, in this way enhancing the chemical activity and bioavailability inside the body. Written by experts from various fields and backgrounds, the book introduces to fundamental physical aspects (explaining differences between the ordered and the disordered solid states, the enhancement of solubility resulting from drugs amorphization, physical instability and how it can be overcome) as well as preparation and formulation procedures to produce and stabilize amorphous pharmaceuticals. Readers will thus gain a well-funded understanding and find a multi-faceted discussion of the properties and advantages of amorphous drugs and of the challenges in producing and stabilizing them. The book is an ideal source of information for researchers and students as well as professionals engaged in research and development of amorphous pharmaceutical products.

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key "aging" markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

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 explores the possible development of neurokinin-3 receptor (NK3R) antagonists with reduced environmental impact. Pharmaceuticals are used to cure diseases and to alleviate symptoms in humans and animals. However, the stable, bioactive substances excreted by patients have unfavorable effects on non-target species. To overcome these disadvantages of these highly stable, potent substances, drug design to turn off bioactivity after release into the environment is needed. The book describes the development of eco-friendly NK3R antagonists by introducing a labile functional moiety and substituting a scaffold. This resulted in a novel NK3R antagonist that oxidized into its inactive form when exposed to air. Further, the book presents an efficient and easily achievable synthetic method of creating triazolopiperazine scaffolds, as well as a structure-activity relationship study involving scaffold hopping for decomposable motifs, which led to a novel photodegradable NK3R antagonist. Demonstrating that it is possible to develop compounds that convert into their inactive forms under environmental conditions, this book is useful for anyone interested in therapeutic agents with reduced environmental impact.

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 book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs. Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized. Addresses economic and practical considerations, unlike many other technical books. Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies. Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

Thanks to their unique properties, chitosan and chitosan-based materials have numerous applications in the field of biomedicine, especially in drug delivery. This book examines biomedical applications of functional chitosan, exploring the various functions and applications in the development of chitosan-based biomaterials. It also describes the chemical structure of chitosan and discusses the relationship between their structure and functions, providing a theoretical basis for the design of biomaterials. Lastly, it reviews chemically modified and composite materials of chitin and chitosan derivatives for biomedical applications, such as tissue engineering, nanomedicine, drug delivery, and gene delivery.

This detailed volume presents a series of protocols dealing with different aspects of inclusion body (IB) processing, from cloning procedures to purification of refolded product. Commencing with chapters on upstream processing, looking into different expression strategies for IB production, the book continues with downstream applications, highlighting early protein purification and subsequent analytics, as well as success stories of IB-based processes. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Inclusion Bodies: Methods and Protocols serves as an ideal resource for facilitating diverse aspects of IB processing.

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.

Demonstrates the conditions under which a 2D-LC method should be considered as an alternative to a 1D-LC method. Establishes a sound fundamental basis of the principles of the technique, followed by guidelines for method optimization. Provides a single source for technical knowledge advances and practical guidance described in recent literature. Assists with the initial decision to develop a 2D-LC method. Guides the reader in developing a high-quality method that meets the needs of their application.

This book covers a wide range of topics concerning human tear based science, starting from basics such as the normal composition of tears and moving up to novel disease detection platforms. The entire approach is pioneering, as tears are beginning to be recognized as the most invaluable non-invasive tool in diagnostics. Interestingly, the concept is not restricted to ocular diseases: In recent years, tear diagnostics is increasingly being tapped even for cancer detection. Hopefully, non-invasive tear diagnostics will eventually replace today's invasive disease detection and monitoring techniques. Previous literature on tear diagnostics has been restricted to scientific journal articles, most of which dealt with a single tear constituent, such as a protein. This book offers a far more comprehensive and handy 'reference guide,' presenting both basic and advanced information and data. Accordingly, it will be useful for researchers in academia and the pharmaceutical industry, as well as healthcare professionals and diagnostic kit developers.

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

Numerous phenomenal advances have been made towards understanding the role of neurotransmitters in the pathophysiology of neurological disorders, and these have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of such disorders. This book provides a comprehensive and detailed explanation of brain neurotransmitters and their receptors and associated channels. It includes a basic introduction, and also discusses the functions and recent advances and their pharmacology, highlighting the role of various computer aided drug design (CADD) strategies for the development of therapeutic ligands to modulate these receptors/ion channels. Written in an easy-to-read style, it is intended for neuroscience and pharmaceutical students and researchers working in the area of brain neurotransmitters.

Leading researchers are specially invited to provide a complete understanding of a key topic within the multidisciplinary fields of physiology, biochemistry and pharmacology. In a form immediately useful to scientists, this periodical aims to filter, highlight and review the latest developments in these rapidly advancing fields.

There is growing interest in the food, supplements, cosmetics, and pharmaceutical industries in improving the healthiness of their products by incorporating lipophilic bioactive substances like oil-soluble vitamins (A, D and E), omega-3 fatty acids, and nutraceuticals (carotenoids, curcuminoids and flavonoids). However, there are many challenges that need to be overcome due to their poor water-solubility, chemical stability, and bioavailability. For this reason, there is interest in the development of effective encapsulation technologies to increase the efficacy of lipophilic bioactives. This book reviews the encapsulation systems currently available for delivering lipophilic bioactives, including their preparation, functionality, and application range, including nanoemulsions, emulsions, Pickering emulsions, HIPEs, microgels, organogels and liposomes. Chapters 1-2 review the biological activity of delivery systems and lipophilic bioactives. Chapters 3-5 describe the materials and preparation methods used to assemble delivery systems. Chapters 6-17 focus on the formation and application of different kinds of delivery systems. Chapter 18 discusses future trends in the development of bioactive delivery systems. Edited and authored by world renowned scholars, the book provides a state-of-the-art overview of the design, fabrication, and utilization of delivery systems for bioactives that will be useful for academic, government, and industrial scientists in fields such as pharmaceuticals, cosmetics, agriculture, chemical engineering, nutrition, and foods.

Antimicrobial resistance is a major global public health problem. This book focuses on the clinical implications of multi-drug resistant pathogens; tracking AMR and its evolutionary significance; antifungal resistance; and current and alternative treatment strategies for AMR, including antivirulent, antibiofilm and antimicrobial resistance breakers, repurposing of drugs, and probiotic therapy. Advances in antimicrobial stewardship, antibiotic policies from a global perspective and their impacts are also discussed. The book also explores the use of omics approaches to gain insights into antibacterial resistance, and includes chapters on the potential benefits of a 'One Health approach' describing the environmental and zoonotic sources of resistant genes and their effects on the global resistance pool.

This book highlights recent innovative work in nutraceutical delivery systems, focusing on strategies and approaches for delivering maximum health benefits from foods. It presents recent research-oriented work from diverse global perspectives on isolation techniques for nutraceutical components, phytosomes, liposomes, solid dispersions, micelles, self-emulsifying drug delivery systems, microemulsions, solid lipid nanoparticles, polyelectrolyte complexes, oral delivery, polymeric nanoparticles, and more. The book begins with an overview of recent facts and diverse perspectives on the use of nutraceuticals in medicine and proceeds to discuss recent techniques in isolation of nutraceuticals from plants and in solubility enhancement. It looks at innovations and advances in nanoparticles-based nutraceutical delivery, such as in solid lipid nanoparticles (SLNs), fabrication methods of therapeutic nanoparticles, and polymeric nanoparticles-based nutraceutical delivery system. It also discusses vesicular delivery systems and biphasic systems for nutraceutical applications. The book also looks at the challenges in oral delivery and the latest taste-masking techniques.

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.

Unique and timely volume as mRNA is a hot area of research making great strides. Covers the full-scale production systems that are needed to develop vaccines as well as elements of data needed to secure the IND approvals. Introduces a commercial-scale manufacturing process using novel techniques like the PCR, in addition to the traditional plasmid DNA. First book that offers commercial technology for developing and large-scale supply of mRNA products. Renowned author and entrepreneur in the field of drug discovery and production.

This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and marketing. Chapters bring together the theories and applications of various disciplines, allowing readers to learn more about quantitative fields, and to better recognize the differences between them. Because it provides a thorough overview, this will serve as a self-contained resource for readers interested in the pharmaceutical industry, and the quantitative methods that serve as its foundation. Specific disciplines covered include: Biostatistics Pharmacometrics Genomics Bioinformatics Pharmacoepidemiology Commercial analytics Operational analytics Quantitative Methods in Pharmaceutical Research and Development is ideal for undergraduate students interested in learning about real-world applications of quantitative methods, and the potential career options open to them. It will also be of interest to experts working in these areas.

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).

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 edited volume brings together the expertise of numerous specialists on the topic of particles - their physical, chemical, pharmacological and toxicological characteristics - when they are a component of pharmaceutical products and formulations. The book discusses in detail properties such as the composition, size, shape, surface properties and porosity of particles with respect to how they impact the formulations and products in which they are used and the effective delivery of pharmaceutical active ingredients. It considers all dosage forms of pharmaceuticals involving particles, from powders to tablets, creams to ointments, and solutions to dry-powder inhalers, also including the latest nanomedicine products. Further, it discusses examples of particle toxicity, as well as the important subject of pharmaceutical industry regulations, guidelines and legislation. The book is of interest to researchers and practitioners who work on testing and developing pharmaceutical dosage and delivery systems.

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.