Explores the utilization of marine surfactants for biological and biomedical applications Provides depth knowledge on marine surfactant preparations Discusses the development of personal care or cosmeceutical products using marine surfactants Examines various marine derived surfactants for treatment of cancer related diseases Reviews marine surfactants for environmental applications

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

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.

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

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.

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.

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.

Advanced Porous Biomaterials for Drug Delivery Applications probes cutting-edge progress in the application of advanced porous biomaterials in drug delivery fields. These biomaterials offer promise in improving upon the design, cost, and creation of potent novel drug delivery systems. The book focuses on two categories: nature engineered and synthetic advanced porous biomaterials, with a wide range of low-cost porous biomaterial-based systems that have been used for the delivery of diverse drugs through in vitro/in vivo approaches. Details how advanced porous biomaterial-assisted systems improve essential properties in drug delivery applications Explains how advanced porous biomaterials systems are being used and explored to improve overall performances of drug delivery systems in mitigating a variety of diseases Emphasizes major applications in drug delivery such as controlled release, cancer therapy, and targeted delivery, and with focus on oral, topical, and transdermal applications Focuses on both naturally available and synthetic low-cost advanced porous biomaterials and their role in enhancing important parameters in drug delivery applications Accessible to readers with bio and non-bio backgrounds This book is an ideal reference for academics, researchers, and industry professionals in the interdisciplinary fields of biomedicine and biomedical engineering, pharmaceuticals, materials science, and chemistry.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

This book is an excursion into the drug development process, from the initial conception in a chemical or molecular biology lab, via tests in isolated cells and animals, to the stage of clinical trials. The human body is a complex ecosystem where little is conclusively known in terms of its response to medication, for both sick and healthy individuals. The considerable degree of uncertainty inherent in health-related research can lead to approval of controversial medicines, particularly in high-stakes scenarios and medical crises. Real-life examples are drawn on here to explain the decision making processes behind the acceptance of new drugs, disproving misconceptions around medicines by delving into the history and current practice of the drug development process.Originally written in Italian, How Medicines are Born helps patients, students, public health officials physicians, healthcare practitioners and biomedical scientists make informed decisions on the benefits and disadvantages of select medicine based on an understanding of the history of drug development.Published in Italian (2014), M D'Incalci & L Vozza, Come Nascono le Medicine; La scienza imperfetta dei farmaci. Bologna: ZanichelliRelated Link(s)