General compendium of HDAC inhibitors with deep emphasis on toxicity issues of synthetic HDAC inhibitors Various groups of natural HDAC inhibitors, their representatives and premier sources Cyclic tetrapeptides of natural origin and their importance as cancer chemotherapeutic agents Hydroxamates and depsipeptides from natural sources and their promising role in cancer therapy Natural Flavonoids, their HDAC inhibitory tendency and marvellous anticancer activity Non-flavonoid natural HDAC inhibitors and their pleasing cytotoxic effects towards cancer models Combined therapy involving natural flavonoids with other anticancer molecules for synergistic and additive benefits against cancer models Non-flavonoid HDAC inhibitors and conventional drugs in collaborative mode against aggressive malignancies Nanotechnology based delivery of natural HDAC inhibitors for greater therapeutic efficacy over traditional combinatorial therapy

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.

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.

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.

This book covers various aspects of cancer chemoprevention, including an overview of chemoprevention in the process of tumorigenesis; the roles of various phytochemicals, functional foods, and dietary interventions in disease prevention; and techniques such as cancer stem cell targeting, nano-formulations, and so forth. The nutrigenomic and epigenetic effects of natural products at the molecular and genetic levels are also covered alongside their potential for additive and synergistic effect, as well as overcoming drug resistance. The key selling features of the book are as follows: Discusses holistic and comprehensive areas of chemoprevention Includes diverse techniques, such as cancer stem cell targeting, nano-formulations, and nanotechnology-based drug delivery systems Introduces various mechanisms involved in prevention of the diseases, including targeting cancer stem cells Reviews various aspects which can reduce the toxicity and cost of treatment of diseases by alternative medicine Explores various sources, mechanisms, and ways to develop cancer chemopreventive agents with minimal toxicity compared to traditional cancer therapy drugs This book is focused on researchers and graduate students in drug delivery and formulation, nanobiotechnology, cancer chemoprevention, prevention, and therapeutics.

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 examines the fundamental concepts of multimodality small-animal molecular imaging technologies and their numerous applications in biomedical research. Driven primarily by the widespread availability of various small-animal models of human diseases replicating accurately biological and biochemical processes in vivo, this is a relatively new yet rapidly expanding field that has excellent potential to become a powerful tool in biomedical research and drug development. In addition to being a powerful clinical tool, a number of imaging modalities including but not limited to CT, MRI, SPECT and PET are also used in small laboratory animal research to visualize and track certain molecular processes associated with diseases such as cancer, heart disease and neurological disorders in living small animal models of disease. In vivo small-animal imaging is playing a pivotal role in the scientific research paradigm enabling to understand human molecular biology and pathophysiology using, for instance, genetically engineered mice with spontaneous diseases that closely mimic human diseases.

This book casts new light on the field of oral drug absorption. It outlines both the concept of the past and the novel concept of Finite Absorption Time (FAT). In addition, the authors explore the correlated need for re-definition of bioavailability, bioequivalence providing a plethora of experimental data. Accordingly, this book is intended for academics/students or scientists working in pharmaceutical industries, regulatory agencies, and contract research organizations. It can be used for teaching purposes in under- and post-graduate courses dealing with biopharmaceutics, pharmacokinetics and biomedical engineering.

The identification of the role of tumor stroma-the tissue in the surroundings of cancer cells-in cancer development, progression, and metastasis has revolutionized the fields of cancer biology as well as cancer therapeutics. This book provides a comprehensive overview of this rapidly-evolving field including tumor stroma biology, therapeutic targets, molecular imaging, and advanced tumor stroma in vitro models. The book will serve as a handbook for graduate students, postgraduate researchers, pharmaceutical scientists, and biomedical engineers.

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

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.

Overview of the development of gene therapy Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing Presents CRISPR gene therapy recent trends and applications Discusses siRNA, mRNA, and DNA plasmids

The disability-adjusted life year (DALY) is a generic measure of health effect that can be used in cost-effectiveness analysis as an alternative to the quality-adjusted life year (QALY). Infectious diseases are one of the major to cause significant losses of DALY and QALY. Human infectious diseases are disorders that are triggered by the micro-organisms such as bacteria, fungi, viruses, or parasites. The majority of such diseases are contagious and create a public health menace. There are several reasons why infectious diseases are deadly diseases, and one of the primary reasons is the drug resistance developed over time. Drug resistance-associated mutations are linked to increasing drug efflux, modifications of the drugs, or their targets. Every year, new drugs are being approved by FDA to treat infectious diseases. Nonetheless, the infectious diseases will undoubtedly persist as permanent and main threats to humanity for now and in the future. A total of four books are covered under the series of Infectious drug diseases. - Malarial drug delivery systems - Tubercular drug delivery systems - Viral drug delivery systems - Infectious disease drug delivery systems Infectious diseases are the world’s greatest killers that present one of the most significant health and security challenges. Humans have lived with emerging and re-emerging pathogens since before the documented history of civilization. The only determining fact today is - If the situation is “worse� or “better� than in past. The answer is probably “worse�, may be due significant increase in human population, increased cross-continent mobility, imbalanced (stressed) life style, irregular food habits leading to compromised innate immunity and over or under practiced hygiene routine. When the incidence of such a disease in people increases over 20 years or threatens to increase, it is called an “emerging� disease, and a growing number have made watch lists and headlines in nearly every country -like highly pathogenic H5N1 avian influenza, severe acute respiratory syndrome (SARS), Ebola virus, food- and waterborne illnesses, and a range of antimicrobial-resistant bacterial diseases TB. This book addresses current and new therapy developments in treating such infectious diseases, updates on finding new drugs, identification of innovative diagnostic methods, understanding of disease research models and clinical trials performances of new treatment modalities. Audiences from a broad range of groups, from researchers, academicians, and public health bodies to regulatory experts, can benefit from the compiled information to learn more about patient needs and current research advances in the field of infectious diseases and related research.

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

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.

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 draws on medical sociology and science and technology studies to develop a novel conceptual framework for understanding innovation processes, using the case study of deep brain stimulation in paediatric neurology. It addresses key questions, including: How are promising and potentially disruptive new health technologies integrated into busy resource-constrained clinical contexts? What activities are involved in establishing a new clinical service? How do social and cultural forces shape these services, and importantly, how are understandings of 'health' and 'illness' reconfigured in the process? The book explores how the ideals of patient-centred medicine influence innovation in the clinic, and it introduces the concept of patient-centred proto-platforms. It argues that patient-centred innovation can constitute an expansion of medical power, as the clinical gaze is directed not only towards the body but also towards the patient as a social being. This will be an innovative and insightful read for academics and advanced students, as well as health service researchers with an interest in technology adoption processes.

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.

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.

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

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

Many polymers derived from various marine sources and microorganisms possess some important biological properties such as biocompatibility, biodegradability, and bioadhesivity that make them attractive as pharmaceutical excipients in various pharmaceutical dosage forms. Moreover, these polymers can be modified physically and/or chemically to improve their biomaterial properties. In this volume, Natural Polymers for Pharmaceutical Applications, Volume 2: Marine- and Microbiologically Derived Polymers, looks at how these polymers have been explored and exploited for pharmaceutical uses, such as in tablets, microparticles, nanoparticles, ophthalmic preparations, gels, emulsions, suspensions, etc. Some commonly used marine- and microbiologically derived polymers used as pharmaceutical excipients include alginates, agar-agar, gellan gum, carrageenan; chitosan, xanthan gum, and others. The book focuses on important recent advances from experts around the world on marine-derived polysaccharides and pharmaceutical applications of alginates, agar-agar, gellan gum, carrageenan, chitosan derivatives, xanthan gum.

In recent years, many animal-derived polymers have emerged as an attractive category of naturally derived polymers because of their advantageous physicochemical, chemical, and biological properties. The important biological properties of these natural polymers derived from animals are biocompatibility and biodegradation. These polymers are generally composed of repeated units of amino acids. Moreover, these polymers can be modified physically and/or chemically to improve their biomaterial properties. Natural Polymers for Pharmaceutical Applications, Volume 3: Animal-Derived Polymers looks at how these polymers can be exploited as pharmaceutical excipients in various pharmaceutical dosage forms, like microparticles, nanoparticles, ophthalmic preparations, gels, implants, etc. The commonly used animal-derived polymers used as pharmaceutical excipients are hyaluronic acid (hyaluronan), albumin, collagen, gelatin, chondroitin, etc.

This first-of-its-kind handbook offers crucial information on the safety of drugs taken during pregnancy. It covers an exhaustive list of common and less common drugs and provides for each drug the FDA letter categorization and newly approved "Pregnancy and Lactation Labeling Rule (PLLR)" systems for rating drug risks in pregnancy, imposed by the U.S. Food and Drug Administration (FDA). Drugs in Pregnancy: A Handbook for Pharmacists and Physicians covers the pregnancy ramifications of using anti-infective, cardiovascular, hematologic, dermatologic drugs and drugs affecting the endocrine, central, autonomic, gastrointestinal, musculoskeletal systems in addition to herbs, vitamins and dietary supplements. To enable the reader to develop well-informed knowledge about a drug safety profile during pregnancy, three sections of data have been provided for each drug: FDA Category, Risk Summary, and Further Reading.

Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.