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.

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.

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

This book closes a current gap by providing the scientific basis for consumer exposure assessment in the context of regulatory risk assessment. Risk is defined as the likelihood of an event occurring and the severity of its effects. The margin between the dose that leads to toxic effects and the actual dose of a chemical is identified by estimating population exposure. The objective of this book is to provide an introduction into the scientific principles of consumer exposure assessment, and to describe the methods used to estimate doses of chemicals, the statistics applied and computer tools needed. This is presented through the backgrounds of the special fields in exposure analysis, such as exposure via food and by the use of consumer products, toys, clothing and other items. As a general concept, human exposure is also understood to include exposure via the environment and from the work setting. In this context, the specific features of consumer exposure are pointed out and put into the context of regulation, in particular food safety, chemicals safety (REACh) and consumer product safety. The book is structured into three parts: The first part deals with the general concepts of consumer exposure as part of the overall risk analysis framework of risk characterization, risk assessment and risk communication. It describes the three basic features of exposure assessment (i) the exposure scenario (ii) the exposure model and (iii) the exposure parameters, addressing external and internal exposure. Also, the statistical presentation of data to characterize populations, in connection with variability, uncertainty and quality of information and the presentation of exposure evaluation results is described. The second part deals with the specific issues of exposure assessment, exposure via food consumption, exposure from use of consumer products, household products, toys, cosmetic products, textiles, pesticides and others. This part also covers methods for acquisition of data for exposure estimations, including the relevant information from regulations needed to perform an accurate exposure assessment. The third part portrays a prospect for further needs in the development and improvement of consumer exposure assessment, as well as international activities and descriptions of the work of institutions that are involved in exposure assessment on the regulatory and scientific level. And conversely, it creates the rationale for the exposure assessment details necessary to satisfy regulatory needs such as derivation of upper limits and risk management issues.

"Hills is probably the best person I can think of to write this book. He has the deepest background combined with considerable experience in solving problems with food." —R. G. Bryant, University of Virginia.

Food scientists have many excellent tools at their disposal with which to study food at both the micro- and macrostructural levels. But, when it comes to analyzing dynamic structural changes in food during processing and storage, none can compare with magnetic resonance imaging (MRI). Still a very young approach, MRI food imaging has contributed greatly to recent advances in food science, and promises to yield much more valuable information in the years ahead. Written by a leading pioneer in the field, Magnetic Resonance Imaging in Food Science covers the latest in MRI food imaging theory and practice.

Written primarily for food scientists and engineers, the book offers a practical, unified approach to the subject. Material is organized in three main parts corresponding to the distances of scale probed by MRI studies—namely, the macroscopic, microscopic, and macromolecular. Throughout, the emphasis is on ways in which studies of food undergoing processes can be modeled using the equations of heat, mass, and momentum transport, and how those models can be used in process design optimization programs.

Magnetic Resonance Imaging in Food Science provides researchers with the most up-to-date, detailed coverage of:

• Traditional and cutting-edge MRI food imaging techniques and technologies, including STRAFI, gradient-echo imaging, and functional imaging
• Whole plant functional imaging, flow imaging and rheology, and other specialized MRI applications
• The roles of food microstructure and molecular relaxation mechanisms in controlling moisture and heat transport
• Techniques for modeling structural changes during food processing.

Magnetic Resonance Imaging in Food Science is an important working resource for all researchers engaged in the never-ending struggle to produce safer, higher-quality foods more efficiently.

Presents cutting-edge research in biomedical engineering from materials, devices, imaging, and information perspectives All chapters are results of collaborative research in engineering and life sciences Useful resource for researchers, students, and general readers in biomedical engineering

Nanotechnology has the potential to change every part of our lives. Today, nanotechnology-based products are used in many areas, and one of the most important areas is drug delivery. Nanoparticulate drug delivery systems not only provide controlled delivery of drugs and improved drug solubility but also improve drug efficiency and reduce side effects via targeting mechanisms. However, compared with conventional drug delivery systems, few nanoparticle-based products are on the market and almost all are nontargeted or only passively targeted systems. In addition, obtaining targeted nanoparticle systems is quite complex and requires several evaluation mechanisms. This book discusses the production, characterization, regulation, and currently marketed targeted nanoparticle systems in a broad framework. It provides an overview of targeted nanoparticles' (i) in vitro characterization, such as particle size, stability, ligand density, and type; (ii) in vivo behavior for different targeting areas, such as tumor, brain, and vagina; and (iii) current advances in this field, including clinical trials and regulation processes.

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

Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.

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.

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 detailed book explores techniques commonly used for research into drug repurposing, a well-known strategy to find alternative indications for drugs which have already undergone toxicology and pharma-kinetic studies but have failed later stages during the development, via computational methods. Thereby, it addresses the intense challenges of identifying the appropriate type of algorithm and relevant technical information for computational repurposing. Written for the highly successful Methods in Molecular Biology series, the authors of each chapter use their experience in the field to describe the implementation and successful use of a specific repurposing method thus providing lab-ready instruction. Authoritative and practical, Computational Methods for Drug Repurposing serves as an ideal guide to researchers interested in this vital area of drug development.

This comprehensive book brings together experts from both the marine science and pharmacy disciplines to relay important aspects on the pharmaceutical and nutraceutical values of 175 species of bony and cartilaginous fishes as well as the uses of fish processing byproducts and wastes.Presented in an easy-to-read style, the volume provides precise identification of freshwater and marine fishes possessing pharmaceutical and nutraceutical compounds along with over 180 photographs. Aspects covered include biology, ecology, diagnostic features, and pharmaceutical and nutraceutical compounds along with their activities for each of the fish included. The book details the bioactive compounds, including fish muscle proteins, peptides, collagen and gelatin, fish oil, etc., from such species, as well as the bioactive peptides that are derived from various fish muscle proteins, which have various biological activities, including cardio protective, antihypertensive, anticancer, anti-diabetic, antibacterial, anticoagulant, anti-inflammatory, and antioxidant activities. Also discussed are the nutritional benefits of fish consumption, which are largely due to the presence of proteins, unsaturated essential fatty acids, minerals, and vitamins. The waste products obtained during fish processing are also a potential source of bioactive peptides that can be used as a source of nitrogen and amino acids, which have immunomodulatory, antibacterial, antitrombotic, and antihypertensive properties. This volume provides the information needed to tap into these vast pharmaceutical and nutraceutical benefits. Pharmaceuticals and Nutraceuticals from Fish and Fish Wastes will be of great use for students and researchers of disciplines such as pharmaceutical sciences, marine/fisheries sciences, marine microbiology, and marine biotechnology. It will also be a standard reference for libraries of colleges and universities and a guide for pharmaceutical companies involved in the development of new drugs from fishes and their wastes.

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a "one of a kind" contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

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.

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.