The proposed book is envisioned for the nascent and entry-level researchers who are interested to work in the field of drug delivery and its applications specifically for macrophage targeting. Macrophages have gained substantial attention as therapeutic targets for drug delivery considering their major role in health and regulation of diseases. Macrophage-targeted therapeutics have now added significant value to the lives and quality of life of patients, without undue adverse effects in multiple disease settings. We anticipate examining and integrating the role of macrophages in the instigation and advancement of various diseases. The major focus of the book is on recent advancements in various targeting strategies using delivery systems or nanocarriers followed by application of these nanocarriers for the treatment of macrophage associated disorders. Macrophage Targeted Delivery Systems is primarily targeted to Pharmaceutical Industry & Academia, Medical & Pharmaceutical Professionals, Undergraduate & Post graduate students and Research Scholars, Ph.D, post docs working in the field of medical and pharmaceutical sciences.

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest - with the most up to date research updates - in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

This book provides a comprehensive overview of FDA (Federal Drug Administration) procedures. It simplifies the complexities involved in getting FDA clearance by using an integrated approach of clinical, engineering, and business aspects. It includes both medical devices and drug development. This involves understanding the structure of the FDA, its purpose, and its initiatives. This book also examines what is needed for designing clinical trials and addressing recalls and failures. It uses case studies to further illustrate the integrated method stressed throughout this work.

This book collects information about the most popular ethnomedicinal plants, which are common in Turkey and around the world. It presents the ethnopharmacological records, in vivo and in vitro studies, side effects, chemical compositions and clinical studies of these medicinal plants. Its special focus is on the novel drug targets for disease and their possible mechanisms of action. It covers botanical descriptions the status of the plants, and food or drug interactions including precautions and warnings about the plants and the available market products. It provides an explanation of recorded and known plant administration dosages. Also, the gap between the traditional practice and scientific/clinical evidences in the use of ethnomedicinal plant is acknowledged. It is well known that traditional knowledge of the use of the medicinal plants in therapy is an important resource for the discovery of novel treatment options and drug targets. The main purpose of this book is to draw attention to ethnomedicinal plant species. Data on the therapeutic potentials of these medicinal plants can now be accessed from a single source. It provides an important resource for future research opportunities for harnessing the full potential of these plants.

This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances.

This book reviews the principles of design and examples of successful implementation of proteinkinase inhibitors (PKI), and offers a comprehensive and authoritative overview of the history and latest developments in the field. Chapters written by experts from industry and academia cover the function, structure and topology of Proteinkinases, molecular modelling, disclose how to achieve high level of selectivity for kinase inhibitors, and exploit kinase inhibitors for cancer treatment. Particular attention is given to Inhibitors of c-Jun N-terminal kinase 3, and to covalent Janus Kinase 3 Inhibitors. A case study on Receptor Tyrosine Kinases EGFR, VEGFR, PDGFR is also presented in this book. Given its breath, this book will appeal to medicinal chemists, students, researchers and professionals alike.

Cosmetics are the most widely applied products to the skin and include creams, lotions, gels and sprays. Their formulation, design and manufacturing ranges from large cosmetic houses to small private companies. This book covers the current science in the formulations of cosmetics applied to the skin. It includes basic formulation, skin science, advanced formulation, and cosmetic product development, including both descriptive and mechanistic content with an emphasis on practical aspects. Key Features: Covers cosmetic products/formulation from theory to practice Includes case studies to illustrate real-life formulation development and problem solving Offers a practical, user-friendly approach, relying on the work of recognized experts in the field Provides insights into the future directions in cosmetic product development Presents basic formulation, skin science, advanced formulation and cosmetic product development

knowledge. This material provided has been collected from different sources. One important source is the material available from EURACHEM. Eurachem is a network of organisations in Europe having the objective of establishing a system for the international tra- ability of chemical measurements and the promotion of good quality practices. It provides a forum for the discussion of common problems and for developing an informed and considered approach to both technical and policy issues. It provides a focus for analytical chemistry and quality related issues in Europe. You can find more information about EURACHEM on the internet via "Eurachem -A Focus for Analytical Chemistry in Europe" (http: //www.eurachem.org). In particular the site Guides and Documents contains a number of different guides, which might help you to set up a quality system in your laboratory. The importance of quality assurance in analytical chemistry can best be described by the triangles depicted in Figs. 1 and 2. Quality is checked by testing and testing guaranties good quality. Both contribute to progress in QA (product control and quality) and thus to establishing a market share. Market success depends on quality, price, and flexibility. All three of them are interconnected. Before you can analyse anything the sample must be taken by someone. This must be of major concern to any analytical chemist. There is no accurate analysis wi- out proper sampling. For correct sampling you need a clear problem definition. There is no correct sampling without a clear problem definition

This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an underlying cohort or target population of interest. This enables various extended designs to be introduced and analysed with a similar approach: extreme sampling on the outcome (extreme case-control design) or on the exposure (exposure-enriched, exposure-density, countermatched), designs that re-use prior controls and augmentation sampling designs. Further extensions exploit aggregate data for efficient cluster sampling, accommodate time-varying exposures and combine matched and unmatched controls. Self-controlled designs, including case-crossover, self-controlled case series and exposure-crossover, are also presented. The test-negative design for vaccine studies and the use of negative controls for bias assessment are introduced and discussed. This book is intended for graduate students in biostatistics, epidemiology and related disciplines, or for health researchers and data analysts interested in extending their knowledge of study design and data analysis skills. This book Bridges the gap between epidemiology and the more mathematically oriented biostatistics books. Assembles the wealth of epidemiological knowledge about observational study designs that is scattered over several decades of scientific publications. Illustrates the performance of methods in real research applications. Provides guidelines for implementation in standard software packages (Stata, R). Includes numerous exercises, covering simple mathematical proofs, consideration of proposed or published designs, and practical data analysis.

Research in the field of epilepsy will continue at a rapid pace, with the ultimate hope of curing many intractable epilepsy syndromes. Fully updated, this new edition is organized chronologically, from neonate through adolescence, and the handbook is the culmination of a group effort involving leading physicians and researchers whose contributions constitute a concise and practical reference for health professionals in training. Here the contributors review the recent flood of new information on the pathophysiology, genetics, and treatment of the various epilepsy syndromes and the volume is distilled into an easy-to-use guide. Fully updated text reviewing the latest research the pathophysiology, genetics, and treatment of the various epilepsy syndromes. Thorough, descriptions of the different syndromes commonly encountered in clinical practice across the pediatric range. Extensive resource section provided. Contributors describe why they chose each particular case, what they learned, and how it changed their practice. Access to a companion website, which offers digital graphics and videos on the topic

Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.

This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.

Counterfeit drugs continue to infiltrate the drug market in the United States, causing illness and death. This book addresses this issue and examines the recent trends in drug counterfeiting over the past 5-10 years. The text shows perspectives from crime lab and toxicology lab personnel and academic researchers, and includes topics such as a history of cases and issues with counterfeit drugs, trends observed in forensic labs, instrumental methods and approaches used in detecting counterfeit medicines, and policy approaches for controlling counterfeit drugs. There is a focus on ways to reduce counterfeit drugs in the market, to help improve the health and safety of people all over the world. Features : Focuses on recent (5-10) year trends in counterfeit drugs and analysis. Shows perspectives from crime lab and toxicology lab personnel and academic researchers. Focuses on drugs seized by law enforcement and approaches to reducing counterfeit medicine in the market. Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue. Emphasizes the global impact of illegal medicines.

Learn how AI and data science are upending the worlds of biology and medicine In Silico Dreams: How Artificial Intelligence and Biotechnology Will Create the Medicines of the Future delivers an illuminating and fresh perspective on the convergence of two powerful technologies: AI and biotech. Accomplished genomics expert, executive, and author Brian Hilbush offers readers a brilliant exploration of the most current work of pioneering tech giants and biotechnology startups who have already started disrupting healthcare. The book provides an in-depth understanding of the sources of innovation that are driving the shift in the pharmaceutical industry away from serendipitous therapeutic discovery and toward engineered medicines and curative therapies. In this fascinating book, you'll discover: An overview of the rise of data science methods and the paradigm shift in biology that led to the in silico revolution An outline of the fundamental breakthroughs in AI and deep learning and their applications across medicine A compelling argument for the notion that AI and biotechnology tools will rapidly accelerate the development of therapeutics A summary of innovative breakthroughs in biotechnology with a focus on gene editing and cell reprogramming technologies for therapeutic development A guide to the startup landscape in AI in medicine, revealing where investments are poised to shape the innovation base for the pharmaceutical industry Perfect for anyone with an interest in scientific topics and technology, In Silico Dreams also belongs on the bookshelves of decision-makers in a wide range of industries, including healthcare, technology, venture capital, and government.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

This book presents recent advances in the use of ionic liquids in medicine and pharmaceutics with particular emphasis on addressing critical pharmaceutical challenges, including the low solubility, polymorphism, and bioavailability of drugs. It also provides insights into the development of the biologically functionalized ionic liquids suitable for medical and pharmaceutical applications. Ionic liquids have been used as potential solvents or materials in the fields of pharmaceutical drug delivery and formulations because of their unique and tunable physicochemical and biological properties. Readers find explanations of the diverse approaches to the application of ionic liquids in drug solubility, active pharmaceutical ingredient (API) formulation, and drug delivery systems, such as topical, transdermal, and oral delivery, with particular emphasis on recent developments. Particular attention is given to the development of ionic liquid-assisted effective drug delivery techniques for sparingly soluble or insoluble drug molecules. This book also discusses the biological activities of ionic liquids for possible applications in drug formulation and drug delivery systems. Scientists in disciplines such as chemistry, biology, and pharmaceutics find this book instructive and informative for developing ionic liquid-based drug formulations or drug delivery systems.

This book provides an insight of relevant case studies and updated practices in "PharmaceuticalSupply Chains" (PharmSC) while addressing the most relevant topics within the COST Action "Medicines Shortages" (CA15105).The volume focuses on the most recent developments in the design, planning and scheduling ofPharmSC, broadening from the suppliers' selection to the impact on patients and healthcaresystems, addressing uncertainty and risk mitigation, and computational issues. It is directed at MSc/PhD students and young researchers (Post-Docs) in Pharmaceutics/Pharmaceutical sciences, Engineering fields, Economics/Management, as well as pharmaceutical decision makers, managers, and practitioners, and advanced readers demanding a fresh approach to decision making for PharmSC. The contributed chapters are associated with the homonymous COST Training Schools (TS), and the book creates a better understanding of the Action "Medicines Shortages" challenges and opportunities.

This volume contains a collection of innovative techniques for studying targeted protein degradation. Chapters guide readers through heterobifunctional proteolysis-targeting chimeras (PROTACs) approaches, E3 ligase, E3 ligase-induced ubiquitylation, proteomic approaches, novel degrader molecules, molecular glue, and stabilize binding interaction between a target and E3 ubiquitin ligase. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Targeted Protein Degradation: Methods and Protocols aims to ensure successful results in this emerging field of drug discovery.

This volume is designed to impart the fundamental concepts in experimental pharmacology, research methodology and biostatistics. Through this book, the readers will learn about different methods involved in drug discovery, experimental animals and their care, equipments and the various bioassays used in experimental pharmacology. This book contains special sections on various drug screening methods involved in the evaluation of different body systems. Certain sections provide the healthcare professionals with the knowledge necessary to interpret clinical research articles, design clinical studies, and learn essential concepts in biostatistics in an expedient and concise manner. Basic principles and applications of simple analytical methods employed in drug analysis are well written under one section. It focuses on the basic and advanced laboratory techniques and also on computer simulated data, written extensively under the Biostatistics section. The methods used for drug analysis have been described in adequate detail with cross-references for further studies and comprehension. Overall, the book is designed systematically with four broad sections with extensive subdivisions for easy tracking, interpretation, and understanding.

Stem cell research, and particularly embryonic stem cell research, while offering the prospect of developing theories for serious life-threatening diseases, also raises a number of difficult and controversial moral questions. This is reflected in a variety of moral perspectives and regulatory regimes, already adopted or in the process of being developed, in EU Member States. In particular the "moral exclusion" clause in Article 6 of the EC Directive on the legal protection of biotechnological inventions has created much uncertainty in this field.
This collection of original essays provides comprehensive analysis of the EU patent system as applied to biotechnological inventions and particularly stem cell research, dealing with the overlapping EPC, EU, international and national law regimes bearing on the exclusion of patents in a morally fragmented and contested field. In this multidisciplinary study, the editors aim to clarify the legal scope of Article 6, which they deem essential for the fostering of research and investment in Europe, while ensuring that such research is conducted within clear ethical limits which address the concerns of society.
As well as a complete overview of the application of the European patent law in the field of human embryonic stem cells, topics covered include legal and philosophical accounts of the boards of the European Court of Justice and European Patent Offices' reasoning in the leading litigated cases, as well as the institutional tensions between national and transnational European research and patent regimes. With its broad research in the fields of patent law, ethics and philosophy, the book analyzes a wide range of issues in a way no other book has previously done and suggests solutions to unblock the current stalemate surrounding the patentability of human embryonic stem cell related inventions. The book will be welcomed by a broad readership, including experts and academics in both ethical and legal disciplines as well as policy makers and regulators in the field of embryonic stem cell research in Europe.

Early anthropological evidence for plant use as medicine is 60,000 years old as reported from the Neanderthal grave in Iraq. The importance of plants as medicine is further supported by archeological evidence from Asia and the Middle East. Today, around 1.4 billion people in South Asia alone have no access to modern health care, and rely instead on traditional medicine to alleviate various symptoms. On a global basis, approximately 50 to 80 thousand plant species are used either natively or as pharmaceutical derivatives for life-threatening conditions that include diabetes, hypertension and cancers. As the demand for plant-based medicine rises, there is an unmet need to investigate the quality, safety and efficacy of these herbals by the "scientific methods". Current research on drug discovery from medicinal plants involves a multifaceted approach combining botanical, phytochemical, analytical, and molecular techniques. For instance, high throughput robotic screens have been developed by industry; it is now possible to carry out 50,000 tests per day in the search for compounds, which act on a key enzyme or a subset of receptors. This and other bioassays thus offer hope that one may eventually identify compounds for treating a variety of diseases or conditions. However, drug development from natural products is not without its problems. Frequent challenges encountered include the procurement of raw materials, the selection and implementation of appropriate high-throughput bioassays, and the scaling-up of preparative procedures. Research scientists should therefore arm themselves with the right tools and knowledge in order to harness the vast potentials of plant-based therapeutics. The main objective of Plant and Human Health is to serve as a comprehensive guide for this endeavor. Volume 1 highlights how humans from specific areas or cultures use indigenous plants. Despite technological developments, herbal drugs still occupy a preferential place in a majority of the population in the third world and have slowly taken roots as alternative medicine in the West. The integration of modern science with traditional uses of herbal drugs is important for our understanding of this ethnobotanical relationship. Volume 2 deals with the phytochemical and molecular characterization of herbal medicine. Specifically, it focuess on the secondary metabolic compounds, which afford protection against diseases. Lastly, Volume 3 discusses the physiological mechanisms by which the active ingredients of medicinal plants serve to improve human health. Together this three-volume collection intends to bridge the gap for herbalists, traditional and modern medical practitioners, and students and researchers in botany and horticulture.

This book is the first of two volumes that offer a comprehensive, up-to-date account of current knowledge regarding high-density lipoprotein (HDL), the changes that occur in HDL under different conditions, the clinical applications of HDL, and means of enhancing HDL functionality. HDL comprises a diverse group of lipoproteins and its composition and metabolism are dynamic. In this volume, the focus is on the changes observed in HDL under different health statuses, with particular attention to the functional and structural correlations of HDL and apolipoprotein A-1. The impacts of a wide variety of factors on HDL are examined in depth, covering, for example, diet, exercise, smoking, age, diverse diseases, and different forms of environmental pollution. It has long been known that HDL has anti-atherosclerotic and antidiabetic properties, and more recently its anti-aging activities have been recognized. These benefits of HDL are highly dependent on its lipids, proteins, apolipoproteins, and enzymes, and specifically their composition and ratios. In documenting the latest knowledge in this field, this volume will be of interest to both researchers and clinicians.

Absorption, Distribution, Metabolism and Excretion (ADME) processes and their relationship with the design of dosage forms and the success of pharmacotherapy form the basis of this upper level undergraduate/graduate textbook. As an introduction oriented to pharmacy students, it is also written for scientist from different fields outside of pharmaceutics. (e.g. material scientist, material engineers, medicinal chemists) who might be working in a positions in pharmaceutical companies or whose work might benefit from basic training in the ADME concepts and some biological background. Pedagogical features such as objectives, keywords, discussion questions, summaries and case studies add valuable teaching tools. This book will provide not only general knowledge on ADME processes but also an updated insight on some hot topics such as drug transporters, multi-drug resistance related to pharmacokinetic phenomena, last generation pharmaceutical carriers (nanopharmaceuticals), in vitro and in vivo bioequivalence studies, biopharmaceuticals, pharmacogenomics, drug-drug and food-drug interactions, and in silico and in vitro prediction of ADME properties. In comparison with other similar textbooks, around half of the volume would be focused on the relationship between expanding scientific fields and ADME processes. Each of these burgeoning fields has a separate chapter in the second part of the volume, and was written with leading experts on the correspondent topic, including scientists and academics from USA and UK (Duquesne University School of Pharmacy, Indiana University School of Medicine, University of Utah College of Pharmacy, University of Maryland, University of Bath). Additionally, each of the initial chapters dealing with the generalities of drug absorption, distribution, metabolism and excretion would include relevant, classic examples related to each topic with appropriate illustrations (e.g. importance of active absorption of levodopa, implications in levodopa administration, drug drug interactions and food drug interactions emerging from the active uptake; intoxication with paracetamol as a result of glutathione depletion, CYP induction and its relationship with acute liver failure caused by paracetamol, etc). ADME Processes and Pharmaceutical Sciences is written as a core textbook for ADME processes, pharmacy, pharmacokinetics, drug delivery, biopharmaceutics, drug disposition, drug design and medicinal chemistry courses.