This consolidated reference book addresses the various aspects of nano biomaterials used in ophthalmic drug delivery, including their characterization, interactions with ophthalmic system and applications in treatments of the ophthalmic diseases and disorders. In the last decade, a significant growth in polymer sciences, nanotechnology and biotechnology has resulted in the development of new nano- and bioengineered nano-bio-materials. These are extensively explored as drug delivery carriers as well as for implantable devices and scaffolds. At the interface between nanomaterials and biological systems, the organic and synthetic worlds merge into a new science concerned with the safe use of nanotechnology and nano material design for biological applications. For this field to evolve, there is a need to understand the dynamic forces and molecular components that shape these interactions. While it is impossible to describe with certainty all the bio physicochemical interactions at play at the interface, we are at a point where the pockets of assembled knowledge are providing a conceptual framework to guide this exploration, and review the impact on future product development. The book is intended as a valuable resource for academics and pharmaceutical scientists working in the field of polymers, polymers materials for drug delivery, drug delivery systems and ophthalmic drug delivery systems, in addition to medical and health care professionals in these areas.

This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

Antisense-based drugs are part of a growing number of pharmaceutical and biotech programs to treat diseases including cancer, diabetes, and ALS. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide from the safety assessment to clinical experience with antisense oligonucleotides. Examines principles and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides Reviews fundamentals and provides guidelines for scientists in drug design and discovery to increase efficiency, assessment, and success of drug candidates Helps readers understand antisense molecules and their targets, biochemistry and toxicity mechanisms, roles in disease, and applications for safety and therapeutics Includes interdisciplinary perspectives, from both academia and research, on a hot topic that combines pharmacology, toxicology, biology, and medicinal chemistry to advance our understanding and application of therapeutics

This book describes 200 bio-polymers, including the most recent and advanced nanotechnology applications. The applications of various bio-medical and other future potential uses are covered and examined in depth. Systematic discussion of current leading natural polymers is also included.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors.

This book addresses the issues relating to a wide variety of ocular diseases from which millions of people suffer. Long-term challenges include visual impairment and ocular blindness. Certain ocular diseases are quite rare, whereas others, such as cataracts, age-related macular degeneration (AMD), and glaucoma, are very common, especially in the aging population. A rapid expansion of new technologies in ocular drug delivery and new drug candidates, including biologics, to treat these challenging diseases in the retina and posterior segments of the eye have recently emerged. These approaches are necessary because the eye has many unique barriers to drug delivery. Thus, this timely reference Drug Delivery for the Retina and Posterior Segment Disease compiles and analyzes recent advances in the research and development of drug delivery systems for retina and posterior segment diseases of the eye, with an emphasis on the use of implantable devices, iontophoresis as well as micro- and nanoparticles.

The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.

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

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul's research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.

Key features include: Details the role of plants for the treatment and management of cancer and diabetes Discusses the role of phytocompounds as ligands for cancer and diabetic targets Reviews plants and the potential of phytochemicals as antidiabetic and anticancer drugs Explores the green biosynthesis of nanoparticles and their treatment efficiency

This SpringerBrief provides an overview of ultrasonic emulsification and an update on recent advances in developing stable emulsions for the creation of novel drugs and functional foods, with a focus on bioactive delivery in these products. Emulsification is the process of combining two or more immiscible liquids to form a semi-stable mixture. These two liquids generally consist of an organic (oil) phase and an aqueous (water) phase that is stabilized by the addition of an emulsifier. Most common emulsions are of the oil-in-water (O/W) type, but can also be of water-in-oil (W/O) or even multiple emulsion types (i.e. double emulsions) in the form of water-in-oil-in-water (W/O/W) or oil-in-water-in-oil (O/W/O) phases. The formation of an emulsion requires input of energy to distribute the disperse phase in the continuous phase in small-sized droplets that are able to resist instability. There is great interest in the use of ultrasound to produce emulsions, as it is able to do so relatively efficiently and effectively compared to existing techniques such as rotor stator, high-pressure homogenization and microfluidization. The interaction of ultrasound with the hydrocolloids and biopolymers that are often used to stabilize emulsions can offer advantages such as improved stability or greater control of formed droplet size distributions.

Immunology has emerged as a key component of the curricula of graduate and postgraduate courses in biotechnology, microbiology, biochemistry, bioinformatics, and other interdisciplinary fields of biology, including zoology, veterinary science, and medicine. As a basic introductory textbook on one of the fastest-moving and most challenging areas of immunological science, this book contains the most recent information about immunologic mechanisms and their importance, along with various molecular techniques employed in immunology. The short and concise text helps make the structures, processes, and interactions of the immune system easily comprehensible. The book includes chapters on immunoinformatics as well as the immune system of the brain, rarely found in any of the immunology books published so far. Many diverse and interesting aspects of the advances in immunology have also been covered, including tumor immunology and immunodeficiency disorders. The easy-to-understand concepts presented in the textbook make it an ideal companion for learners preparing for competitive and other examinations. Undergraduate, postgraduate, and PhD students, people from the industry and academia, and research scholars will immensely benefit from it.

This brief describes studies conducted by the authors on mid-size drugs utilizing peptides and peptidomimetics, and on the development of anti-HIV agents. Peptides are important biological molecules and have various physiological actions. Peptide-based drug discovery may help bring about the development of useful medicines that are highly safe and show potent pharmacological effects in small doses. Recently, it has been shown that there is an important drug-like space in the mid-sized region between low- and high-molecular-weight compounds. Thus, mid-size drugs such as peptide compounds are being focused on. To date, several peptidomimetics that mimic primary, secondary, and tertiary structures of peptides have been developed to maintain and improve biological activities and actions of peptides. In this book, the features and advantages of mid-size drugs are described in detail. In addition, the merits of utilizing peptidomimetics in the development of mid-size drugs are referred to. Understanding such peptide-derived mid-size drugs will lead to a comprehensive expansion of medicinal chemistry.

This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key "aging" markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

This fully updated new edition presents organic reaction mechanism questions, carefully selected from the primary chemical literature, to understand how reactants are transformed into products. The author explains step-by-step solutions to all problems with appropriate contextual comments explaining the rationale and reasoning underlying each step, and identifying the underlying principles involved in each question. In the process the reader gains a better understanding of the fundamental principles of organic chemistry and how to become proficient in using the Lewis acid/Lewis base concept to complete organic reactions without resorting to memorization. Features : The questions are graded in difficulty with Part A containing questions aimed at students taking the sophomore-level organic chemistry class, while part B contains questions of somewhat greater difficulty suitable for students taking an honors course in organic chemistry or a beginning graduate course. Detailed answers are provided to all questions so students can check their answers and important points are highlighted in each answer. Special emphasis has been placed on the selection of questions to ensure that each question illustrates one or more fundamental principles of organic chemistry. Interspersed throughout the book are minireviews that cover the material pertaining to a particular topic. The specific literature references corresponding to each question are included and students can look up those references for more contextual information. Includes a large number of carefully-selected mechanism questions and step-by-step solutions, including explanatory comments

Tackling translational medicine with a focus on the drug discovery development-interface, this book integrates approaches and tactics from multiple disciplines, rather than just the pharmaceutical aspect of the field. The authors of each chapter address the paradox between the molecular understanding of diseases, drug discovery, and drug development. Laying out the detailed trends from various fields, different chapters are dedicated to target engagement, toxicological safety assessments, and the compelling relationship of optimizing early clinical studies with design strategies. The book also highlights the importance of balancing the three pillars: sufficient efficacy, acceptable safety and appropriate pharmacokinetics, all of which are crucial to successful efforts in discovery and development. With discussions regarding the combined approaches of molecular research, personalized medicine, pre-clinical and clinical development, as well as targeted therapies-this compendium is a flexible fit, perfect for professionals in the pharmaceutical industry and related academic fields.

This work presents a systematic review of traditional herbal medicine and their active compounds, as well as their mechanism of action in the prevention and treatment of diabetes and obesity. The side effects and safety of herbal-derived anti-diabetic and anti-obesity phytochemicals are detailed in depth, and the text has a strong focus on current and future trends in anti-diabetic medicinal plants. This unique and comprehensive text is the only current book on the market focusing exclusively on medicinal plants used to combat obesity and diabetes. An introductory chapter focuses on diabetes and obesity and introduces the major causes and main treatments of this increasing epidemic in modern society. Readers are then introduced to medicinal plants, including details on their therapeutic aspects, plus side effects and safety. Following chapters focus on anti-diabetic and anti-obesity medicinal plants, as well as phytogenic natural products in the treatment of each. The text closes by focusing on present and future trends and challenges in these medicinal plants. Anti-diabetes and Anti-obesity Medicinal Plants and Phytochemicals: Safety, Efficacy, and Action Mechanisms is a much-needed and truly original work, finally presenting in one place all the necessary information on medicinal plants used in conjunction with obesity and diabetes prevention.

Authored by leading experts from academia, users and manufacturers, this book provides an authoritative account of the science and technology involved in multiparticulate drug delivery systems which offer superior clinical and technical advantages over many other specialized approaches in drug delivery. The book will cover market trends, potential benefits and formulation challenges for various types of multiparticulate systems. Drug solubility, dose, chemistry and therapeutic indications as well as excipient suitability coupled with manufacturing methods will be fully covered. Key approaches for taste-masking, delayed release and extended release of multiparticulates systems are of significant interest, especially their in-vivo and in-vitro performance. In addition, the principles of scale-up, QbD, and regulatory aspects of common materials used in this technology will be explained, as well as recent advances in materials and equipment enabling robust, flexible and cost-effective manufacture. Case studies illustrating best practices will also make the book a valuable resource to pharmaceutical scientists in industry and academia.

The book covers theoretical background and methodology as well as all current applications of Quantitative Structure-Activity Relationships (QSAR). Written by an international group of recognized researchers, this edited volume discusses applications of QSAR in multiple disciplines such as chemistry, pharmacy, environmental and agricultural sciences addressing data gaps and modern regulatory requirements. Additionally, the applications of QSAR in food science and nanoscience have been included - two areas which have only recently been able to exploit this versatile tool. This timely addition to the series is aimed at graduate students, academics and industrial scientists interested in the latest advances and applications of QSAR.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

This book provides an overview of the world market of therapeutic enzymes and enzyme inhibitors, rare diseases, orphan drugs, the costs of drug development and therapies, and enzymes in downstream processing of pharmaceuticals. It discusses carbonic anhydrase inhibitors and their multiple drug interactions, carboxylesterase inhibitors for pharmaceutical applications, employment of inhibitors for the treatment of neurodegenerative diseases, use of engineered proteins, bioactive peptides, and fibrinolytic enzymes for thrombolytic therapy, and enzymes important for the design and development of new drugs/drug metabolites such as aldehyde oxidases and cytochrome P450 enzymes and the role the latter play in vascular biology and pathophysiology. The treatment of cancer is explored in connection with enzymatic amino acid deprivation therapies and new drugs that act as chemical degraders of oncogenic proteins. The book also introduces the resistance mechanisms of cancer. Furthermore, it provides an insight into the relationship between pathological conditions of cardiovascular disease and oxidative stress. The text also focuses on the potential use of nanoparticles as carriers for enzymes with medical relevance, computer-aided drug design for the identification of multi-target directed ligands, and the development of improved therapeutics through a glycan-"designer" approach. It concludes with an introduction to the chemoenzymatic synthesis of drugs.

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.

This invaluable reference presents a comprehensive review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake-offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs. Evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport! Written by over 50 international experts and reflecting broad knowledge of both traditional bioadhesive strategies and novel clinical applications, Bioadhesive Drug Delivery Systems discusses mechanical and chemical bonding, polymer-mucus interactions, the effect of surface energy in bioadhesion, polymer hydration, and mucus rheology analyzes biochemical properties of mucus and glycoproteins, cell adhesion molecules, and cellular interaction with two- and three-dimensional surfaces covers microbalances and magnetic force transducers, atomic force microscopy, direct measurements of molecular level adhesions, and methods to measure cell-cell interactions examines bioadhesive carriers, diffusion or penetration enhancers, and lectin-targeted vehicles describes vaginal, nasal, buccal, ocular, and transdermal drug delivery reviews bioadhesive interactions with the mucosal tissues of the eye and mouth, and those in the respiratory, urinary, and gastrointestinal tracts explores issues of product development, clinical testing, and production and more! Amply referenced with over 1400 bibliographic citations, and illustrated with more than 300 drawings, photographs, tables, and display equations, Bioadhesive Drug Delivery Systems serves as a sound basis for innovation in bioadhesive systems and an excellent introduction to the subject. This unique reference is ideal for pharmaceutical scientists and technologist

Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.