This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

This comprehensive volume compiles the concepts essential for the understanding of the pharmaceutical science and technology associated with the delivery of subunit vaccines. Twenty-one chapters are divided into four main parts: (I) Background; (2) Delivery Systems for Subunit Vaccines; (3) Delivery Routes, Devices and Dosage Forms; and (4) Pharmaceutical Analysis and Quality Control of Vaccines. Part one provide a basic background with respect to immunology and general vaccine classification. In part two, it presents representative types of vaccine delivery systems individually with focus on the physicochemical properties of the systems and their significance for the immune response they stimulate. These delivery systems include aluminum adjuvants, emulsions, liposomes, bilosomes, cubosomes/hexosomes, ISCOMs, virus-like particles, polymeric nano- and microparticles, gels, implants and cell-based delivery systems. Following these chapters, part three addresses the challenges associated with vaccine delivery via specific routes of administration-in particular subcutaneous, intramuscular, oral, nasal, pulmonary, transdermal and vaginal administration. Furthermore, the specific administration routes are discussed in combination with device technologies relevant for the respective routes as well as dosage forms appropriate for the device technology. Finally, the fourth part concerns pharmaceutical analysis and quality control of subunit vaccines.

Behcet's syndrome can reasonably be considered a unique entity among diseases of the immune system for several reasons: It has specific features and, uniquely among the immune system pathologies, represents a link between autoimmune diseases, systemic vasculitis, and autoinflammatory diseases. In addition, it is of interest to a variety of specialists, including immunologists, rheumatologists, dermatologists, and ophthalmologists, and requires a complex multidisciplinary approach. Many aspects need to be considered in a syndrome that presents a wide spectrum of symptoms and for which the therapeutic armamentarium is expanding significantly, with the development of new treatments, not least the so-called biologics. This book offers comprehensive coverage of the disease by some of the world's leading experts in Behcet's syndrome from all the relevant specialties. Epidemiology, genetics, pathogenesis, organ system involvement, differential diagnosis, novel treatments, surgical management, and prognosis are just some of the topics addressed. Behcet's Syndrome: From Pathogenesis to Treatment will be an invaluable reference for a range of practitioners, researchers, and undergraduates or postgraduates interested in immuno-rheumatology, dermatology, and rare diseases.

In this book emphasis will be put in the relevance of Plant Biotechnology for producing compounds of pharmaceutical and industrial relevance specifically the contribution of in vitro plant cell cultures for producing recombinant proteins (molecular farming) and compounds produced by plants useful for human and animal health (secondary metabolites) will be discussed. Also the description of some process held by whole plants will be included. The aim will be to provide relevant theoretical frameworks and the latest empirical research findings for professionals and researchers working in the field of Plant Biotechnology, molecular farming and biochemical engineering.

Attention has recently turned to using plants as hosts for the production of commercially important proteins. The twelve case studies in this volume present successful strategies for using plants to produce industrial and pharmaceutical proteins and vaccine antigens. They examine in detail projects that have commercial potential or products that have already been commercialized, illustrating the advantages that plants offer over bacterial, fungal or animal cell-culture hosts. There are many indications that plant protein production marks the beginning of a new paradigm for the commercial production of proteins that, over the next decade, will expand dramatically.

This book presents a detailed overview of the development of new viral vector-based vaccines before discussing two major applications: preventive vaccines for infectious diseases and therapeutic cancer vaccines. Viral vector-based vaccines hold a great potential for development into successful pharmaceutical products and several examples at the advanced pre-clinical or clinical stage are presented. Nevertheless, the most efforts were focused on novel and very innovative technologies for new generation of vector-based vaccines. Furthermore, specific topics such as delivery and adjuvant and protection strategies for cell-mediated-based vaccines are presented. Given its scope, the book is a "must read" for all those involved in vaccine development, both in academia and industrial vaccine development.

Volume III of this manual provides an overview of the analytical investigation of 23 additional Chinese Herbal Drugs, which are most commonly used in Traditional Chinese Medicine. Together with Volumes I and II this current volume represents the most comprehensive overview to analytical studies of those herbal drugs. The quality proof of the investigation meets the standard of the European Drug Regulatory Authority. The authors refer to the bioactive constituents, pharmacological and biological activities of all single herbal drugs, as well as their therapeutic applications. Analytical methods applied are described in detail.

The 2012 International Conference on Applied Biotechnology (ICAB 2012) was held in Tianjin, China on October 18-19, 2012. It provides not only a platform for domestic and foreign researchers to exchange their ideas and experiences with the application-oriented research of biotechnology, but also an opportunity to promote the development and prosperity of the biotechnology industry. The proceedings of ICAB 2012 mainly focus on the world's latest scientific research and techniques in applied biotechnology, including Industrial Microbial Technology, Food Biotechnology, Pharmaceutical Biotechnology, Environmental Biotechnology, Marine Biotechnology, Agricultural Biotechnology, Biological Materials and Bio-energy Technology, Advances in Biotechnology, and Future Trends in Biotechnology. These proceedings are intended for scientists and researchers engaging in applied biotechnology. Professor Pingkai Ouyang is the President of the Nanjing University of Technology, China. Professor Tongcun Zhang is the Director of the Key Laboratory of Industrial Fermentation Microbiology of the Ministry of Education at the College of Bioengineering, Tianjin University of Science and Technology, China. Dr. Samuel Kaplan is a Professor at the Department of Microbiology & Molecular Genetics at the University of Texas at Houston Medical School, Houston, Texas, USA. Dr. Bill Skarnes is a Professor at Wellcome Trust Sanger Institute, United Kingdom.

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

This volume focuses on current evidence-based pharmacological treatments of various forms of pulmonary hypertension and provides a comprehensive review of the latest developments in this area. The first part of the book covers the definition, classification, pathophysiology, pathology, biomarkers and animal models of the disease, thus laying the conceptual basis for what follows. The middle section provides an overview of the established therapies, such as calcium channel blockers, prostanoids, endothelin receptor antagonists, phosphodiesterase-5 inhibitors and inhaled nitric oxide. The last section explores novel pathways and emerging therapeutic approaches including soluble guanylate cyclase stimulators, Rho-kinase inhibitors, inhibitors of serotonin receptors and transporters, peptide growth factors, vasoactive peptides, modulators of redox equilibrium and cyclic nucleotide homeostasis, as well as immunosuppressive and anti-proliferative agents. Particular attention is given to the clinical applications of these experimental therapies, that are on the horizon. The book thus spans the continuum from basic science to clinical applications.

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.

Modern Strategy for Preclinical Pharmaceutical R&D Towards the Virtual Research Company David Cavalla Arachnova Ltd, Cambridge, UK With contributions from: John Flack AMRAD Corporation, Richmond, Australia and Richard Jennings Wolfson Industrial Liaison Office, University of Cambridge, UK The twentieth century has been a great success for modern medicine, and has resulted in the generation of a plethora of drugs to treat most common illnesses. However, in the light of increasing regulatory demands, spiralling costs and diminishing commercial returns, the question of how, when, where and whether to conduct pharmaceutical R&D has profound implications, and not just for those within the pharmaceutical industry. Modern Strategy for Preclinical Pharmaceutical R&D gets to the heart of the debate that surrounds this topic and asks the questions: Can the economies of scale of large multinational pharmaceutical companies adequately compensate for the loss of creative individualism that is essential for the process of drug discovery and development? Might technological experts provide better services to a number of clients rather than work within a single large infrastructure where confidentiality is paramount and synergy of multi-disciplinary operation readily possible? What are the long-term prospects for the latest alternatives to large pharmaceutical R&D companies? In response to these and other dilemmas, the authors define the processes involved in drug R&D, explore the advantages and disadvantages of collaborative methods of drug research, and examine the roles that academia, CROs, small 'biotechnology' companies and 'research boutiques', and possibly even the 'virtual research company'might play as contractors and collaborators. Without a doubt, Modern Strategy for Preclinical Pharmaceutical R&D is essential reading for all those interested in making sense of the confusion that surrounds today's pharmaceutical industry.

Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of: A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

The author has summarized a decade of teaching combinatorial chemistry into this timely brief. The solid phase synthesis of unnatural heterocyclic alpha-amino acids is illustrated by practical examples starting from the ABCs of peptide synthesis explored in chapter one. Chapter two is concerned with the solid phase synthesis which is shown on various techniques - BillBoard, tea-bag, and Lantern devices, and demonstrated on heterocyclic examples and protocols. In the third chapter the tools for accelerating chemical synthesis - solid phase and liquid phase - are reviewed. Here the techniques of parallel refluxing (including microwave and flow technique) and parallel separation (filtration, centrifugation, evaporation, and chromatography) are described. In the chapters 4 and 5 the author goes on to describe how the liquid phase synthesis of heterocycles (reductive amination and Ugi reaction of heterocycles) is illustrated with the use of semi-automated protocols. Finally, the design of combinatorial libraries of heterocycles is reviewed including the original author's findings.

Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development * Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery * Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis * Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives * Brings together the most current advances in the mass spectrometry technology and related method in protein analysis

Until the 1990s, it was generally accepted that medicines were first developed for adults and their use in children was investigated later, if at all. One of the main tasks of hospital pharmacies was the manufacturing of child-appropriate formulations in a more or less makeshift way. The first change came in 1997 with U.S. legislation that rewarded manufacturers to do voluntary pediatric research. Ten years later, the European Union passed legislation that required manufacturers to discuss all pediatric aspects, including formulations, with the regulatory authorities as a condition of starting the registration procedure. In consequence, manufacturers must now cover all age groups, including the youngest ones. So far, pediatric formulations were more a focus for academic researchers. Through the changed regulatory environment, there is now a sudden high commercial demand for age-appropriate formulations. This book begins by highlighting the anatomical, physiological and developmental differences between adults and children of different ages. It goes on to review the existing technologies and attempts to draw a roadmap to better, innovative formulations, in particular for oral administration. The regulatory, clinical, ethical and pharmaceutical framework is also addressed.

Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals. Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.

Transporters in Drug Development examines how membrane transporters can be dealt with in academic-industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters' impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are explored, and the book highlights perspectives of applying targeted proteomics and mechanistic modeling in this process.

A collection of information on the use of color additives in the food, cosmetic and medical industries. This Third Edition documents important recent developments such as newly listed products, delisted products, modernized specifications and improved analytical technology, new manufacturers and suppliers. A general background of color additives is given including their history, regulation, areas of use and purity requirements.

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.

Combined modularized therapies for metastatic cancer are pointing to central problems of communication among 'systems participators'. A communication theory explains 'social engineering', endogenously induced or by implementing non-normative boundary conditions. Evolution-adjusted tumor pathophysiology is borne by an evolution theory, which contrasts narrative evolution histories. The tool of rationalizations constituting the tumor's normativity (inflammation, immune response etc.) represents the non-genomic counterpart of the tumor genome and should be additionally assessed during tumor staging. Evolution-adjusted tumor pathophysiology allows implementing applied systems biology, a novel clinical and pharmaceutical technology for bioengineering tumor response and personalizing tumor therapy. Combined modularized therapy, evolution-adjusted tumor pathophysiology, and 'universal' biomarkers concertedly address genetically based tumor heterogeneity.

Vitamin C holds a unique place in scientific and cultural history. In this book, a group of leading scientific researchers describe new insights into the myriad ways vitamin C is employed during normal physiological functioning. In addition, the text provides an extensive overview of the following: the rationale for utilizing vitamin C in the clinic, updates on recent uses of vitamin C in cancer treatment through high-dose intravenous therapies, the role vitamin C plays in the treatment of sepsis and infectious disease, management of the ways vitamin C can improve stem cell differentiation, as well as vitamin C use in other important health situations. Features Includes chapters from a team of leading international scholars Reviews the history and recent research on the functions, benefits, and uses of vitamin C Focuses special attention on the way vitamin C can be used in the treatment of cancers Discusses how vitamin C can be employed against infectious disease

The Medical Review Officer's Guide to Drug Testing makes it easy to understand current federal guidelines and select the best approaches for your needs. Tables, checklists, and record-keeping forms help you standardize your drug testing operations. This reference also reviews federal drug testing regulations, describes drug testing procedures and addresses risk management strategies.

Through this monograph, the pharmaceutical chemist gets familiar with the possibilities electroanalytical methods offer for validated analyses of drug compounds and pharmaceuticals. The presentation focuses on the techniques most frequently used in practical applications, particularly voltammetry and polarography. The authors present the information in such a way that the reader can judge whether the application of such techniques offers advantages for solving a particular analytical problem. Basics of individual electroanalytical techniques are outlined using as simple language as possible, with a minimum of mathematical apparatus. For each electroanalytical technique, the physical and chemical processes as well as the instrumentation are described. The authors also cover procedures for the identification of electroactive groups and the chemical and electrochemical processes involved. Understanding the principles of such processes is essential for finding optimum analytical conditions in the most reliable way. Added to this is the validation of such analytical procedures. A particularly valuable feature of this book are extensive tables listing numerous validated examples of practical applications. Various Indices according to the drug type, the electroactive group and the type of method as well as a subject and author index are also provided for easy reference.

Natural products and functional/medical foods are now widely acknowledged as having an effect on the microbiome of the intestine, which in turn influences the outcome of certain disease. This book reviews the impact and effects of natural products and functional/medical foods (nutritional programming) on disease management, specifically focusing on diseases related to 1) Inflammation and Immunity, 2) Cancer, COPD and Cachexia, 3) Allergy and 4) Brain Neuro/Immune. Hippocrates said "let medicine be thy food and food be thy medicine". While most of us are familiar with Hippocrates famous words, we admit that in recent times, the disciplines of pharma and nutrition have evolved separately. Today, with the ever growing burden of diseases in modern society, we see a convergence of the two in relation to specific disease prevention and treatment. This re-discovered common ground between the complementary values of pharma and nutrition can be conceptualized in the term pharma-nutrition. Various chapters in the book review the aspects of molecular characteristics of food ingredients towards clinical effectiveness and relevance.