Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account.

The recent introduction of nanomedicines in the drug therapy arena is revolutionizing the management of severe diseases. The key advance in the field is the optimization of the biological fate of drug molecules, thus improving the therapeutic effect while keeping to a very minimum the associated toxicity. Volume one of this book series, Nanoplatforms in Drug Delivery, established the basic aspects in the development of drug-loaded nanoplatforms, the so-called nanomedicines or nanodrugs, focusing on representative materials and strategies used in their formulation. Taking advantage of the advanced conceptualizations on nanomedicine engineering that were described in volume one, volume two, Nano-Engineering Strategies and Nanomedicines against Severe Diseases, analyzes in depth special features related to the formulation of nanoplatforms for oral, dental, topical and transdermal, pulmonary and nasal, ocular and otic, vaginal, and brain drug delivery and targeting. Particular aspects of nanomedicine engineering and in vivo fate associated with the routing of drug administration are given special attention. In addition, an up-to-date view is presented on the use of nanomedicines against severe diseases, such as cancer, cardiovascular diseases, neurodegenerative disorders, infectious diseases, chronic inflammatory diseases, and metabolic diseases. The chapters analyze the key factors that need to be controlled to achieve the optimum therapeutic effect. Attention is further given to gene delivery and the recent concept of nanotheranosis.

With chapters from highly skilled, experienced, and renowned scientists and researchers from around the globe, Dendrimers for Drug Delivery provides an abundance of information on dendrimers and their applications in the field of drug delivery. The volume begins with an introduction to dendrimers, summarizing dendrimer applications and the striking features of dendrimers. It goes on to present the details of usual properties, structure, classification, and methods of synthesis, with relevant examples. The toxicity of dendrimers is also discussed. The chapter authors provide an exhaustive amount of information about dendrimers and their biomedical applications, including biocompatibility and toxicity aspects, a very useful feature. This informative volume will be valuable resource that will help readers to create products derived from dendrimers and navigate through the regulatory, manufacturing, and quality control hurdles. It will be an important resource for researchers, scientists, upper-level students, and industry professionals.

This collection provides detailed information on current advances in analytical methods and strategies employed for monitoring and discovering a wide range of novel psychoactive substances (NPS) in clinical and forensic laboratories. The main classes of NPS in terms of prevalence include synthetic cannabinoids, synthetic cathinones, synthetic opioids, and designer or synthetic benzodiazepines, and this book explores selecting the appropriate sample matrix and analytical testing approaches for laboratories faced with NPS drug testing, such as in blood, urine, saliva, and hair. Written for the Methods in Pharmacology and Toxicology series, chapters in this volume feature the kind of detailed implementation advice from the experts that leads to successful results in the lab. Authoritative and practical, Methods for Novel Psychoactive Substance Analysis serves as an ideal guide for forensic and clinical toxicologists, pharmacologists and chemists in academic and research settings, as well as for private laboratories seeking to increase our ability to test for these substances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:-536869121 1107305727 33554432 0 415 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:11.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; mso-bidi-font-size:11.0pt; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• the indirect developments from FDA/EU/Japan regulators and industry
• the role of QA department, and internal and external suppliers
• the integration of computer systems validation into single overall approach for wider system
• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
• managing outsource partners and handling legacy systems
• topical issues uncovered by regulatory authorities including US FDA

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Accounts in Drug Discovery describes recent case studies in medicinal chemistry with a particular emphasis on how the inevitable problems that arise during any project can be surmounted or overcome. The Editors cover a wide range of therapeutic areas and medicinal chemistry strategies, including lead optimization starting from high throughput screening "hits" as well as rational, structure-based design. The chapters include "follow-ons" and "next generation" compounds that aim to improve upon first generation agents. This volume surveys the range of challenges commonly faced by medicinal chemistry researchers, including the optimization of metabolism and pharmacokinetics, toxicology, pharmaceutics and pharmacology, including proof of concept in the clinic for novel biological targets. The case studies include medicinal chemistry stories on recently approved and marketed drugs, but also chronicle "near-misses", i.e., exemplary compounds that may have proceeded well into the clinic but for various reasons did not result in a successful registration. As the vast majority of projects fail prior to registration, much can be learned from such narratives. By sharing a wide range of drug discovery experiences and information across the community of medicinal chemists in both industry and academia, we believe that these accounts will provide insights into the art of medicinal chemistry as it is currently practiced and will help to serve the needs of active medicinal chemists.

Dendrimers, hyperbranched macromolecules, emerged just few decades ago but show promising potential as drug delivery nanocarriers, theranostic agents and gene vectors; in the pharmaceutical research and innovation area as well as in other healthcare applications. Although tremendous advancements have been made in dendrimer chemistry and their applications since their emergence, the synthesis, development and design of pure and safe dendrimer-based products have been a major challenge in this area. This book, edited by well-known researchers in the area of nanomaterials and drug-based drug delivery applications, exhaustively covers the nanotechnological aspects, concepts, properties, characterisation, application, biofate and regulatory aspects of dendrimers. It includes sixteen vivid chapters by renowned formulators, researchers and academicians from all over the world, highlighting their specialised areas of interest in the fields of chemistry, biology, pharmacy and nanomedicine. Features: * Highlights dendrimers' advancements in nanomedicine in the development of safe healthcare and biotechnological products * Covers physicochemical aspects, biofate, drug delivery aspects and gene therapy using dendrimers * Covers biomedical application of dendrimers in the field of biological sciences * Gives examples of dendrimer-guest interaction chemistry Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives provides the comprehensive overview of the latest research efforts in designing, optimising, development and scale-up of dendrimer-mediated delivery systems. It analyses the key challenges of synthesis, design, molecular modelling, fundamental concepts, drug delivery aspects, analytical tools and biological fate as well as regulatory consideration to the practical use of dendrimer application. Dr. Neelesh Kumar Mehra Assistant Professor of Pharmaceutics in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He has authored more than sixty peer-reviewed publications in highly reputed international journals, as well as book chapters and contributions on two patents. Dr. Mehra has 11 years of rich research and teaching experience in the formulation and development of complex, innovative biopharmaceutical products including micro- and nanotechnologies for regulated markets. Dr. Keerti Jain Assistant Professor of Pharmaceutics in the Department of Pharmaceutics, NIPER, Raebareli, India. For more than 10 years, she has been actively engaged in formulation and development of nanomedicines. Dr. Jain has supervised masters and doctoral pharmaceutics students in their research works which have been published in high quality, good impact factor journals. She has also authored more than 60 international manuscripts in peer reviewed high impact journals. In 2019, she was awarded the prestigious ICMR-Amir Shakuntala Award.

This "Second Edition" brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
REVISION OF A BESTSELLER - provides updates on the quality control regulations for APIs that have been added or amended since the first edition to ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries
NEW CHAPTERS - on safety, efficacy, and environmental/regulatory requirements keeps readers up-to-date with the latest in the field
EXPERT ANALYSIS - of the recent movement of API manufacturing from the US and Europe to countries such as India and China keeps pharmaceutical professionals and drug manufacturers aware of current and potential changes in regulations
DETAILED DISCCUSIONS - of both US and international regulatory requirements and the FDA's intensified foreign inspection program enables readers to adequately prepare for and pass inspections

The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models; discusses problems related to frailty models, such as tests for homogeneity; and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using the statistical packages of R, SAS, and Stata. The appendix provides the technical mathematical results used throughout. Written in nontechnical terms accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real-world data application and interpretation of the results. By applying several models to the same data, it allows for the comparison of their advantages and limitations under varying model assumptions. The book also employs simulations to analyze the finite sample size performance of the models.

Highlighting 15 selected chiral structures, which represent candidate or marketed drugs, and their chemical syntheses, the authors acquaint the reader with the fascinating achievements of synthetic and medicinal chemistry.

The book starts with an introduction treating the discovery and development of a new drug entity. Each of the 15 subsequent chapters presents one of the target structures and begins with a description of its biological profile as well as any known molecular mechanisms of action, underlining the importance of its structural and stereochemical features. This section is followed by detailed discussions of synthetic approaches to the chiral target structure, highlighting creative ideas, the scaling-up of laboratory methods and their replacement by efficient modern technologies for large-scale production. Nearly 60 synthetic reactions, most of them stereoselective, catalytic or biocatalytic, as well as chiral separating methodologies are included in the book.

Vitomir Sunjic and Michael J. Parnham provide an invaluable source of information for scientists in academia and the pharmaceutical industry who are actively engaged in the interdisciplinary development of new drugs, as well as for advanced students in chemistry and related fields.

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Consumer interest in diet and nutritional supplements is increasing dramatically. Patients and members of the public are seeking advice from health professionals, nutritionists and food scientists. This book is designed to meet the needs of those professionals who are called upon to advise patients and the general public. It provides also a valuable text for those who are researchers or decision makers in the food and pharmaceutical industries. The text presents a thorough account of this topical subject and enables the reader to appreciate the functions of nutrients in health and common disease states, to understand the current debates over the roles of nutrients and supplements in the diet, and to answer those questions frequently asked by patients and consumers.

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity. The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods. A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Until now, the area of drug metabolism and pharmacokinetics has been lacking in texts written for the Medicinal Chemist. This outstanding book, aimed at postgraduate medicinal chemists and those working in industry, fills this gap in the literature. Written by medicinal chemists and ADMET scientists with a combined experience of around 300 years, this aid to discovering drugs addresses the absorption, distribution, metabolism, excretion and toxicity (ADMET) issues associated with drugs. The book starts by describing drug targets and their structural motifs before moving on to explain ADMET for the medicinal chemist. It is the functional groups which most profoundly influence the drug molecules of which they form a part. They characterise the pharmacology, are essential to the activity, and alter the ADMET characteristics of each drug. Their effects follow a pattern, thus allowing medicinal chemists to predict and overcome potential challenges. For this reason, the Editors have taken the unique approach of dividing the remainder of the book into chapters which each focus on a different functional group. They describe drugs containing the functional group under consideration, explain why the group is there, and outline its physicochemical properties before going on to detail the ADMET issues. Where possible, prodrugs and bioisosteres, which may give alternative ADMET outcomes, are described. The chapters cross refer where similar matters are covered but individual chapters can be used in a stand alone manner. The book ends with a discussion of future targets and chemistry needs.

Site-specific drug delivery and targeting is attracting much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Bringing together leading field experts, Targeted Delivery of Small and Macromolecular Drugs summarizes current progress with a focus on the novel ideas being explored to overcome these challenges.

Focuses on the Targeted Drug Delivery Technologies that Utilize
both Systemic and Local Routes of Administration
Leading experts discuss some of the most promising strategies for drug targeting. They also cover targeted drug delivery platforms and technologies at various stages of clinical and preclinical development, including:

? Active targeting
? Nucleic acid delivery and targeting
? Intracellular/Organelle-Specific Strategies
? Prodrug Strategies
? Organ or Tissue-Specific drug delivery
? Drug-Polymer Conjugates and Micelles
? Stimuli-Responsive systems

Targeted Delivery of Small and Macromolecular Drugs demonstrates why targeted delivery is one of the most exciting contributions pharmaceutical sciences can make to drug therapy.

This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.

This book outlines the production of chitooligossacharides and their derivatives and discusses their main biological activities, biomedical applications and their role in disease prevention. Chitooligosaccharides are products of chitosan or chitin degradation, prepared by enzymatic or chemical hydrolysis of chitosan, and they consist mainly of N-acetyl glucosamine and glucosamine bonded with a glycosidic bond. Compared to chitin and chitosan, chitooligossacharides offer advantages for large-scale and commercial applications due to their solubility in water and lower molecular weight. Written by leading experts, this book is divided into four parts. The first part provides a general introduction to chitooligossacharides. The second part focuses on the bioproduction of chitooligossacharides through enzymatic synthesis and also covers physical and chemical methods of synthesis. The third part explores the major biological activities of chitooligosaccharides, including antioxidant, antimicrobial, anti-allergic, anti-inflammatory, anti-cancer and neuroprotective activities, and discusses the disease preventing mechanisms of chitooligosaccharides. In this section, readers will also find about the latest in vivo studies which support the use of chitooligosaccharides in the prevention and control of disease. The final part highlights important biomedical applications of chitooligosaccharides, including in tissue engineering, drug delivery and wound healing applications. It also includes the volume editor's perspective on the health and safety risks of chitooligosaccharides. Given its scope, this book is useful not only for researches in the field but also for students interested in biomaterials, pharmaceuticals, marine biotechnology, nutraceuticals and food science.

This key volume of the Target Organ Toxicology Series provides a fresh and modern approach to the subject of skin toxicology from the perspective of how the skin forms a barrier that protects the body from the external environment and how chemicals and drugs interact with the barrier properties of the skin. Any defects or perturbations to this barrier may result in damage to the skin or may alter absorption. With contributions from over 40 international experts in the field of skin biology, the book presents the central role of the skin barrier to health and disease reviewing; The skin's anatomy and physiology, with focus on the stratum corneum as a barrier to foreign substances. Dermal absorption, cutaneous metabolism, and epidermal transporters. Altered barriers, racial skin types, aged skin, photoaged skin, cosmetics and skin sensitization. Modern approaches to drug delivery across the skin barrier, including liposomes, microneedle technology, active and passive transdermal delivery. Examples and case studies of chemical toxicity after topical exposures ranging from arsenic, metal working fluids, bromine, jet fuel, sulfur mustard and including the emerging area of nanomaterial penetration. Toxicology of the Skin is essential reading for drug delivery pharmacologist, formulation scientists, dermatologists, toxicologists, molecular biologists, engineers, surgeons, students and anyone interested in skin irritation and skin absorption.