Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd "living fossil" (Limulus). It is used to detect remnants of the most primitive and destructive forms of life (prokaryotes) as contaminants of complex modern systems (mammalian and Pharma). Recent challenges in the field include those associated with the application of traditional methods to new types of molecules and manufacturing processes. The advent of "at will" production of biologics in lieu of harvesting animal proteins has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are widely acknowledged, the realization of the differences in the means of production and changes in the manner of control of potential impurities and contaminants in regard to the new versus the old are less widely appreciated. Endotoxin as an ancient, dynamic interface between lifeforms, provides a singular perspective from which to view the parallel development of ancient and modern organisms as well as the progress of man in deciphering the complexity of their interactions in his efforts to overcome disease.

The first and only book on Spray-freeze-drying" which is a relatively recent drying technique, that provides the signature advantages of spray-drying and freeze-drying, while overcoming the limitations of both. Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Contains 200+ illustrations and tabulations Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics, and flavors.

This new volume, Natural Polymers for Pharmaceutical Applications, Volume 1: Plant-Derived Polymers, presents some of the latest research on the applications of natural polymers in drug delivery and therapeutics for healthcare benefits. Polymers and their applications from several plants are discussed in depth, including tamarind gum, gum Arabic, natural carbohydrate polymer gum tragacanth, pectin, guar gum and its derivatives, locust bean gum, sterculia gum, okra gum, and others. The use of the polymers derived from plants as potential pharmaceutical excipients is expanding day by day because of their stability in the biological system, drug-releasing capability, drug-targeting abilities, as well as their bioavailability.

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.

As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn't always work well. Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy. The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence. Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid. The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA. The book includes a Foreword by Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Woman's Hospital.

"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.

Particularly in healthcare fields, there is growing movement away from traditional lecture style course towards active learning and team-based activities to improve learning and build higher level thinking through application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Also unique to this text is the integration of case studies based upon modern pharmaceutical products which are designed to reinforce importance pharmaceutical concepts and teach essential skills in literature review and patent searching. Case studies covering all topics covered in the text have been developed by the authors that allow application of the content in the flipped-classroom pharmaceutical course.

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.

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.

The book presents an innovative technology based on injection of a very weak current to trace the quantity of a drug carried immediately after the administration. The book makes the reader familiar with the technology, from the conception through the design of the instrument, up to the preliminary clinical applications. In the first chapter, the method of transdermal drug delivery and the use of impedance spectroscopy in the dermatological field are presented. The second chapter describes a screening measurement campaign aimed at proving the feasibility of the assessment method and identifying the bandwidth of interest. The prototyping, validation and characterization of an instrument to measure the amount of drug delivered (DUSM: Drug Under Skin Meter) are presented in chapter three. In the fourth chapter three experimental campaigns, based on the electrical analysis of the biological tissue behavior due to the drug delivery, are reported: (i) laboratory emulation on eggplants, (ii) ex-vivo tests on pig ears, and finally (iii) in-vivo tests on human volunteers. In the fifth chapter a behavioral model, based on Finite Elements and Partial Differential Equation, of an impedance-based measurement system for assessing the drug released under the skin, during transdermal delivering, is proposed. The last chapter is dedicated to present a campaign in order to prove the suitability for insulin therapy applications. This book is intended for biomedical engineers, biomedical engineering students, operators working in the field of biomedical instrumentation, biotechnologists, and technicians of transdermal vehiculation.

This book contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system. CAPA violations along with ineffective complaint investigations continue to be the number one cited violation of device warning letters for the past four years, leading the US Food and Drug Administration or FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities. A review of FDA warning letters issued to pharmaceutical companies reveals that most of these warning letters resulted from recurring failures, ineffective investigations found, and missing or inappropriate corrective and preventive actions. Companies often make the mistake of fixing problems in their processes by revising procedures or more commonly by 'retraining' employees that may or may not have caused the problem. This is typically event-focused. Companies then will make the false assumption that the errors have been eradicated. In many cases they will also consider the steps taken as their Preventive Action. The reality is that the causes of the failure were never actually determined; therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach. It is a process and has to be understood throughout organizations. This book addresses all of the above issues, in a pragmatic, down- to-earth manner.

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.

Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.

Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.

The definitive compendium of bioassay procedures and applications

A virtual encyclopedia of key bioassay protocols, this up-to-date, essential resource reviews the methods and applications of bioassays that quantify drug activity and evaluate the validity of pharmacological models.

Demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules, the book covers the evaluation and screening of drug compounds in a wide spectrum of therapeutic categories.

Throughout, the authors use various models to link experimental observations with findings that clarify the effect of drug compounds on cellular biology and measure the pharmacological activity of chemical substances. This provides an important technological platform for successful drug research and clinical therapy, making "Pharmaceutical Bioassays" an ideal sourcebook for pharmacologists, pharmaceutical and medical researchers, analytical chemists, toxicologists, and students.

Just as a fundamental knowledge of pharmaceutical bioassays is vital to understanding how bioactive agents and new drugs are defined, discovered, and developed, so too is this indispensable reference, which:

Offers a complete reference on pharmaceutical bioassays and their specific applications in the assessment of therapies for cancer, Alzheimer's, diabetes, epilepsy, inflammation, antimalarials, pharmacogenomics, and other major therapeutic areas

Covers bioassays that measure toxicity, including those for chemical toxicity and hepatoxicity--a particularly significant consideration in the development of safe and tolerable medications

Highlights clinically relevant methods, ideas, and techniques to support any pharmaceutical researcher

Suggests guidelines and systems to enhance communication between pharmacologists, chemists, and biologists

Provides an informative analysis of pharmaceutical bioassay technologies and lab applications

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.

Prodrug Design: Perspectives, Approaches and Applications in Medicinal Chemistry provides a focused overview of this critical area of drug discovery, as that continuous process strives not only to discover new drug compounds but also to modify the existing ones. This valuable primer supports this mission of drug development and its goal of reducing undesired effects and improving therapeutic effectiveness of drug compounds. Providing a unique compilation of data, insightful case studies, and review of existing literature in the area, the book will promote innovation in medicinal and pharmaceutical chemistry research, exploring the limitations of existing drugs and their improvement. Prodrug Design reviews marketed compounds, the safety of promoieties, and a detailed classification of prodrugs organized by therapeutic area for easy reference.

Recent research in science establishes a direct relation between human gut and skin. Several species of live microbes inhabit the human skin and intestines which far outnumbers the mammalian cells in the human body. Research interest of Nextgen scientists is focused on beneficially harnessing this microbial population to address skin disorders like acne, rosacea, eczema, premature aging, and skin cancer which are established to be a result of skin-microbiome dysbiosis. This volume highlights evidence-based endeavours of the scientific community in this sector. Currently there is no concrete literature which gives a detailed vision on the relationship between gut microbiota and skin related disorders. This volume is an attempt to put together available data in the area and demonstrate usefulness of probiotics as a new therapeutic option for management of these skin diseases which currently show poor prognosis, high cost of treatment and compromised quality of life of the patient.

Medicinal Plants: Chemistry, Biology and Omics reviews the phytochemistry, chemotaxonomy, molecular biology, and phylogeny of selected medicinal plant tribes and genera, and their relevance to drug efficacy. Medicinal plants provide a myriad of pharmaceutically active components, which have been commonly used in traditional Chinese medicine and worldwide for thousands of years. Increasing interest in plant-based medicinal resources has led to additional discoveries of many novel compounds, in various angiosperm and gymnosperm species, and investigations on their chemotaxonomy, molecular phylogeny and pharmacology. Chapters in this book explore the interrelationship within traditional Chinese medicinal plant groups and between Chinese species and species outside of China. Chapters also discuss the incongruence between chemotaxonomy and molecular phylogeny, concluding with chapters on systems biology and "-omics" technologies (genomics, transcriptomics, proteomics, and metabolomics), and how they will play an increasingly important role in future pharmaceutical research.

Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Ocimum species has been used as a traditional remedy for various ailments such as arthritis, bronchitis, cold, conjunctivitis, diarrhea, dysentery, and flatulence, as well as for healing wounds and lowering blood glucose level. These are characterized by variations in their morphology such as the shape, size and pigmentation of leaves, which cause differences in chemical composition and affect the commercial value of this genus. This book describes phytochemical investigations of Ocimum species using LC-MS/MS instruments to study qualitative and quantitative variations of phytochemicals in different Ocimum species. Features: Collection of Ayurvedic features and scientific analytical and pharmacological evidence of most important medicinal plants of genus Ocimum. Chemical signatures for the identification of Ocimum species. Easy-to-use analytical procedure for quality control of plants of Ocimum species and its herbal products.