Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation.

Allosteric Modulation of G Protein-Coupled Receptors reviews fundamental information on G protein-coupled receptors (GPCRs) and allosteric modulation, presenting original research in the area and collectively providing a comprehensive description of key issues in GPCR allosteric modulation. The book provides background on core concepts of molecular pharmacology while also introducing the most important advances and studies in the area. It also discusses key methodologies. This is an essential book for researchers and advanced students engaged in pharmacology, toxicology and pharmaceutical sciences training and research. Many of the GPCR-targeted drugs released in the past decade have specifically worked via allosteric mechanisms. Unlike direct orthosteric-acting compounds that occupy a similar receptor site to that of endogenous ligands, allosteric modulators alter GPCR-dependent signaling at a site apart from the endogenous ligand. Recent methodological and analytical advances have greatly improved our ability to understand the signaling mechanisms of GPCRs. We now know that allostery is a common regulatory mechanism for all GPCRs and not - as we once believed - unique to a few receptor subfamilies.

Tailor-Made Polysaccharides in Drug Delivery provides extensive details on all the vital precepts, basics and fundamental aspects of tailored polysaccharides in the pharmaceutical and biotechnological industry for understanding and developing high quality products. The book offers a comprehensive resource to understand the potential of the materials in forming new drug delivery methods. It will be useful to pharmaceutical scientists, chemical engineers, and regulatory scientists and students actively involved in pharmaceutical product and process development of tailored-made polysaccharides in drug delivery applications. The utilization of natural polymeric excipients in numerous healthcare applications demand the replacement of the synthetic polymers with the natural ones due to their biocompatibility, biodegradability, economic extraction and readily availability. The reality behind the rise in importance of these natural materials is that these sources are renewable if grown in a sustainable means and they can tender incessant supply of raw materials. Amongst these natural polymers, polysaccharides are considered as excellent excipients because of its non-toxic, stable, biodegradable properties. Several research innovations have been made on applications of polysaccharides in drug delivery.

"This fascinating and most timely critical medical anthropology study successfully binds two still emergent areas of contemporary anthropological research in the global world: the nature and significant impact of multinational pharmaceutical manufacturers on human social life everywhere, and the contribution of corporations to the fast-paced degradation of our life support system, planet Earth. . . . Focusing on a pharmaceutically-impacted town on the colonized island of Puerto Rico, Dietrich ably demonstrates the value of ethnography carried out in small places in framing the large issues facing humanity." -Merrill Singer, University of Connecticut The production of pharmaceuticals is among the most profitable industries on the planet. Drug companies produce chemical substances that can save, extend, or substantially improve the quality of human life.However, even as the companies present themselves publicly as health and environmental stewards, their factories are a significant source of air and water pollution--toxic to people and the environment. In Puerto Rico, the pharmaceutical industry is the backbone of the island's economy: in one small town alone, there are over a dozen drug factories representing five multinationals, the highest concentration per capita of such factories in the world. It is a place where the enforcement of environmental regulations and the public trust they ensure are often violated in the name of economic development. The Drug Company Next Door unites the concerns of critical medical anthropology with those of political ecology, investigating the multi-faceted role of pharmaceutical corporations as polluters, economic providers, and social actors. Rather than simply demonizing the drug companies, the volume explores the dynamics involved in their interactions with the local community and discusses the strategies used by both individuals and community groups to deal with the consequences of pollution. The Drug Company Next Door puts a human face on a growing set of problems for communities around the world. Accessible and engaging, the book encourages readers to think critically about the role of corporations in everyday life, health, and culture.

Antioxidants Effects in Health: The Bright and the Dark Side examines the role that antioxidants play in a variety of health and disease situations. The book discusses antioxidants' historical evolution, their oxidative stress, and contains a detailed approach of 1) endogenous antioxidants, including endogenous sources, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; 2) synthetic antioxidants, including sources, chemistry, bioavailability, legal status, mechanisms of action, beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies; and 3) natural antioxidants, including sources, chemistry, bioavailability, mechanisms of action, possible prooxidant activity; beneficial and detrimental effects on health, in vitro evidence, animal studies and clinical studies. Throughout the boo, the relationship of antioxidants with different beneficial and detrimental effects are examined, and the current controversies and future perspectives are addressed and explored. Antioxidants Effects in Health: The Bright and the Dark Side evaluates the current scientific evidence on antioxidant topics, focusing on endogenous antioxidants, naturally occurring antioxidants and synthetic antioxidants. It will be a helpful resource for pharmaceutical scientists, health professionals, those studying natural chemistry, phytochemistry, pharmacognosy, natural product synthesis, and experts in formulation of herbal and natural pharmaceuticals.

Chitosan in Biomedical Applications provides a thorough insight into the complete chitosan chemistry, collection, chemical modifications, characterization and applications of chitosan in biomedical applications and healthcare fields. Chitosan, a biopolymer of natural origin, has been explored for its variety of applications in biomedical research, medical diagnostic aids and material science. It is the second most abundant natural biopolymer after cellulose, and considered as an excellent excipient because of its non-toxic, stable, biodegradable properties. Several research innovations have been made on applications of chitosan in biomedical applications. The book explores key topics, such as molecular weight, degree of deacetylation, and molecular geometry, along with an emphasis on recent advances in the field written by academic, industry, and clinical researchers. Chitosan in Biomedical Applications will be of interest to those in biomedical fields including the biomaterials and tissue engineering community investigating and developing biomaterials for biomedical applications, particularly graduate students, young faculty and others exploring chitosan-based materials.

Delivery Technologies for Immuno-Oncology: Volume 1: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy examines the challenges of delivering immuno-oncology therapies. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. Nanotechnology-based targeted delivery strategies could improve the delivery efficiency of IO agents as well as provide additional avenues for novel therapeutic and vaccination strategies. Additionally, a number of locally-administered immunogenic scaffolds and therapeutic strategies, such as the use of STING agonist, could benefit from rationally designed biomaterials and delivery approaches. Delivery Technologies for Immuno-Oncology: Volume 1: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

Chitosan in Drug Delivery provides thorough insights into chitosan chemistry, collection, chemical modifications, characterization and applications in the pharmaceutical industry and healthcare fields. The book explores molecular weight, degree of deacetylation and molecular geometry, emphasizing recent advances in the field as written by academic, industry and regulatory scientists. It will be a useful resource for pharmaceutical scientists, including industrial pharmacists, analytical scientists, postgraduate students, health care professionals and regulatory scientists actively involved in pharmaceutical product and process development in natural polymers containing drug delivery.

Nanoparticle therapeutics: Production Technologies, Types of Nanoparticles, and Regulatory Aspects employs unique principles for applications in cell-based therapeutics, diagnostics and mechanistics for the study of organ physiology, disease etiology and drug screening of advanced nanoparticles and nanomaterials. The book focuses on the extrapolation of bioengineering tools in the domain of nanotechnology and nanoparticles therapeutics, fabrication, characterization and drug delivery aspects. It acquaints scientists and researchers on the experiential and experimental aspects of nanoparticles and nanotechnology to equip their rational application in various fields, especially in differential diagnoses and in the treatment of diverse diseased states. This complete resource provides a holistic understanding of the principle behind formation, characterization, applications, regulations and toxicity of nanoparticles employing myriad principles of nanotechnology. Investigators, pharmaceutical researchers, and advanced students working on technology advancement in the areas of designing targeted therapies, nanoscale imaging systems and diagnostic modalities in human diseases where nanoparticles can be used as a critical tool for technology advancement in drug delivery systems will find this book useful.

Systemic Drug Delivery Strategies: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy, Volume 2 examines the challenges of delivering immuno-oncology therapies, focusing specifically on the multiple technologies of affective drug delivery strategies. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. This volume of Delivery Strategies and Engineering Technologies in Cancer Immunotherapy discusses methods of targeting tumors, CRISPR technology, and vaccine delivery among many other delivery strategies. Systemic Drug Delivery Strategies: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy, Volume 2 creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists.

Dendrimer-Based Nanotherapeutics delivers a comprehensive resource on the use of dendrimer-based drug delivery. Advances in the application of nanotechnology in medicine have given rise to multifunctional smart nanocarriers that can be engineered with tunable physicochemical characteristics to deliver one or more therapeutic agent(s) safely and selectively to cancer cells, including intracellular organelle-specific targeting. This book compiles the contribution of dendrimers in the field of nanotechnology to aid researchers in exploring dendrimers in the field of drug delivery and related applications. This book covers the history of the area to the most recent research. The starting chapter covers detailed information about basic properties about dendrimers i.e. properties, nomenclature, synthesis methods, types, characterization of dendrimers, safety and toxicity issues of dendrimers. Further chapters discuss the most recent advancements in the field of dendrimer i.e. dendrimer-drug conjugates, PEGylated dendrimer, dendrimer surface engineering, dendrimer hybrids, dendrimers as solubility enhancement, in targeting and delivery of drugs, as photodynamic therapy, in tissue engineering, as imaging contrast agents, as antimicrobial agents, advances in targeted dendrimers for cancer therapy and future considerations of dendrimers. Dendrimer-Based Nanotherapeutics will help the readers to understand the most recent progress in the field of dendrimer-based research, suitable for pharmaceutical scientists, advanced students, and those working in related healthcare fields.

Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy examines the challenges of delivering immuno-oncology therapies, focusing specifically on the development of solutions for drug delivery and its clinical outcomes. Immuno-oncology (IO) is a growing field of medicine at the interface of immunology and cancer biology leading to development of novel therapeutic approaches, such as chimeric antigen receptor T-cell (CAR-T) and immune checkpoint blockade antibodies, that are clinically approved approaches for cancer therapy. Although currently approved IO approaches have shown tremendous promise for select types of cancers, broad application of IO strategies could even further improve the clinical success, especially for diseases such as pancreatic cancer, brain tumors where the success of IO so far has been limited. This volume of Delivery Strategies and Engineering Technologies in Cancer Immunotherapy discusses biomaterial, microfluidic, and biodegradable devices, engineered microbes, personalized medicine, clinical approval process, and many other IO technologies. Engineering Technologies and Clinical Translation: Volume 3: Delivery Strategies and Engineering Technologies in Cancer Immunotherapy creates a comprehensive treaty that engages the scientific and medical community who are involved in the challenges of immunology, cancer biology, and therapeutics with possible solutions from the nanotechnology and drug delivery side.

Direct Nose-to-Brain Drug Delivery provides the reader with precise knowledge about the strategies and approaches for enhanced nose-to-brain drug delivery. It highlights the development of novel nanocarrier-based drug delivery systems for targeted drug delivery to the brain microenvironments with a focus on the technological advances in the development of the novel drug delivery devices for intranasal administration, including special emphasis on brain targeting through nose. This book explores the various quantification parameters to assess the brain targeting efficiency following intranasal administration and includes an overview on the toxicity aspects of the various materials used to develop the direct nose-to-brain drug delivery vehicles and of the regulatory aspects including patents and current clinical status of the potential neurotherapeutics for the effective management of neuro-ailments. Technological advances in new drug delivery systems with diverse applications in pharmaceutical, biomedical, biomaterials, and biotechnological fields are also explained. This book is a crucial source that will assist the veteran scientists, industrial technologists, and clinical research professionals to develop new drug delivery systems and novel drug administration devices for the treatment of neuro-ailments.

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce.

At present, human society is facing a health care crisis that is affecting patients worldwide. In the United States, it is generally believed that the major problem is lack of affordable access to health care (i.e. health insurance). This book takes an unprecedented approach to address this issue by proposing that the major problem is not lack of affordable access to health care per se, but lack of access to better, safer, and more affordable medicines. The latter problem is present not only in the United States and the developing world but also in countries with socialized health care systems, such as Europe and the rest of the industrialized world. This book provides a comparative analysis of the health care systems throughout the world and also examines the biotechnology and pharmaceutical industries.

Examines the health care structure of the United States, Europe, and the third world, both separately and comparativelyOffers primary source insight through in-depth interviews with pharmaceutical and health care industry leaders from around the worldCarefully explains, in clear terms, the intricacies of the health care and pharmaceutical system and how these intricacies have led to the current crisisOffers concrete, comprehensive solutions to the health care crisis

Herbal Biomolecules in Healthcare Applications presents extensive detailed information on all the vital principles, basics and fundamental aspects of multiple herbal biomolecules in the healthcare industry. This book examines important herbal biomolecules including alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, terpenes, fats and waxes, proteins and peptides, and vitamins. These herbal biomacromolecules are responsible for different bioactivities as well as pharmacological potentials. A systematic understanding of the extraction, purification, characterization, applications of these herbal biomolecules and their derivatives in healthcare fields is developed in this comprehensive book. Chapters explore the key topics along with an emphasis on recent research and developments in healthcare fields by leading experts. They include updated literature review of the relevant key topics, good quality illustrations, chemical structures, flow charts, well-organized tables and case studies. Herbal Biomolecules in Healthcare Applications will be useful for researchers working on natural products and biomolecules with bioactivity and nutraceutical properties. Professionals specializing in scientific areas such as biochemistry, pharmacology, analytical chemistry, organic chemistry, clinics, or engineering focused on bioactive natural products will find this book useful.

Multifunctional Theranostic Nanomedicines in Cancer focuses on new trends, applications, and the significance of novel multifunctional nanotheranostics in cancer imaging for diagnosis and treatment. Cancer nanotechnology offers new opportunities for cancer diagnosis and treatment. Multifunctional nanoparticles harboring various functions-including targeting, imaging, and therapy-have been intensively studied with the goal of overcoming the limitations of conventional cancer diagnosis and therapy. Thus theranostic nanomedicines have emerged in recent years to provide an efficient and safer alternative in cancer management. This book covers polymer-based therapies, lipid-based therapies, inorganic particle-based therapies, photo-related therapies, radiotherapies, chemotherapies, and surgeries. Multifunctional Theranostic Nanomedicines in Cancer offers an indispensable guide for researchers in academia, industry, and clinical settings; it is also ideal for postgraduate students; and formulation scientists working on cancer.

Tailor-Made Polysaccharides in Biomedical Applications provides extensive details on all the vital precepts, basics, and fundamental aspects of tailored polysaccharides in the pharmaceutical and biotechnological industries. This information provides readers with the foundation for understanding and developing high-quality products. The utilization of natural polymeric excipients in numerous healthcare applications demands the replacement of the synthetic polymers with natural polymers. Natural polymers are superior in terms of biocompatibility, biodegradability, economic extraction, and ready availability. Natural polymers are especially useful in that they are a renewable source of raw materials, as long as they are grown sustainably. Among these natural polymers, polysaccharides are considered as excellent excipients because they are nontoxic, stable, and biodegradable. Several research innovations have been carried out using polysaccharides in drug delivery applications. This book offers a comprehensive resource to understand the potential of these materials in forming new drug delivery methods. It will be useful to biomedical researchers, chemical engineers, regulatory scientists, and students who are actively involved in developing pharmaceutical products for biomedical applications by using tailor-made polysaccharides.

Phytochemical Profiling of Commercially Important South African Plants comprises a carefully selected group of plant species that are of interest to researchers and industry partners who would like to investigate the commercialization of plant species. The book presents 25 botanicals selected based on commercial relevance. For each of the species, the following topics are covered: botanical description and distribution, phytochemistry (including chemical structures), HPTLC fingerprint analysis, UPLC analysis, and GC analysis (the latter only in the case of essential oil-bearing species). Using standard methodology, high-level chromatographic fingerprints have been developed for better understanding. Different methods are succinctly summarized allowing for the rapid identification of botanical raw materials and formulated consumer products. This book will be extremely valuable to researchers in the field who wish to rapidly identify the constituents and for those who want to prepare formulations of plant material for commercial applications. This work will also be a valuable resource in the field of pharmacognosy.

Global Perspectives on Astaxanthin: From Industrial Production to Food, Health, and Pharmaceutical Applications explores the range of practical applications for this molecule, focusing on nutraceutical, pharmaceutical and cosmeceutical products, along with food and feed. This volume brings together the most relevant research, background and future thinking on astaxanthin, focusing on its health benefits. Chapters cover phytopharmaceuticals, industrial production, feeds, downstream processing, regulations, products, color, pigment, cosmetics, bioactive compounds, relationships to other carotenoids, and skin care. The detailed information on its production, processing, utilization and future applications will be of particular use to academic and industry researchers in pharmaceutical sciences, pharmacology and nutrition.