This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous edition, and will also include additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech.

Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.​

The development of innovative drugs is becoming more difficult while relying on empirical approaches. This inspired all major pharmaceutical companies to pursue alternative model-based paradigms. The key question is: How to find innovative compounds and, subsequently, appropriate dosage regimens? Written from the industry perspective and based on many years of experience, this book offers: - Concepts for creation of drug-disease models, introduced and supplemented with extensive MATLAB programs - Guidance for exploration and modification of these programs to enhance the understanding of key principles - Usage of differential equations to pharmacokinetic, pharmacodynamic and (patho-) physiologic problems thereby acknowledging their dynamic nature - A range of topics from single exponential decay to adaptive dosing, from single subject exploration to clinical trial simulation, and from empirical to mechanistic disease modeling. Students with an undergraduate mathematical background or equivalent education, interest in life sciences and skills in a high-level programming language such as MATLAB, are encouraged to engage in model-based pharmaceutical research and development.

This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer's disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

This book is devoted to the graphics of patient data: good graphs enabling straightforward and intuitive interpretation, efficient creation, and straightforward interpretation. We focus on easy access to graphics of patient data: the intention is to show a large variety of graphs for different phases of drug development, together with a description of what the graph shows, what type of data it uses, and what options there are. The main aim is to provide inspiration in form of a "graphics cookbook." Many graphs provide creative ideas about what can be done. The book is not intended to be technical. It introduces general principles of good visualization to make readers understand the concepts, but the main focus is on the creativity and usefulness: readers are enabled to browse through the book to get ideas of how their own data can be analyzed graphically. For additional information visit Editor's companion website: http://www.elmo.ch/doc/life-science-graphics/

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.

Since penicillin and salvarsan were discovered, a number of new drugs to combat infectious diseases have been developed, but at the same time, the number of multi-resistant microorganism strains is increasing. Thus, the design of new and effective antibacterial, antiviral and antifungal agents will be a major challenge in the next years. This book reviews the current state-of-the-art in antimicrobial research and discusses new strategies for the design and discovery of novel therapies. Topics covered include the use of genetic engineering, genome mining, manipulation of gene clusters, X-ray and neutron scattering as well as the antimicrobial effects of essential oils, antimicrobial agents of plant origin, beta-lactam antibiotics, antimicrobial peptides, and cell-wall-affecting antifungal antibiotics.

Extensive experimentation and high failure rates are a well-recognised downside to the drug discovery process, with the resultant high levels of inefficiency and waste producing a negative environmental impact. Sustainable and Green Approaches in Medicinal Chemistry reveals how medicinal and green chemistry can work together to directly address this issue. After providing essential context to the growth of green chemistry in relation to drug discovery in Part 1, the book goes on to identify a broad range of practical methods and synthesis techniques in Part 2. Part 3 reveals how medicinal chemistry techniques can be used to improve efficiency, mitigate failure and increase the environmental benignity of the entire drug discovery process, whilst Parts 4 and 5 discuss natural products and microwave-induced chemistry. Finally, the role of computers in drug discovery is explored in Part 6.

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.

The use of honey can be traced back to the Stone Age. Evidence can be found for its nutritional and medicinal use beginning with prehistoric and ancient civilizations. Currently, there is a resurgence of scientific interest in natural medicinal products, such as honey, by researchers, the medical community, and even the general public. Honey in Traditional and Modern Medicine provides a detailed compendium on the medical uses of honey, presenting its enormous potential and its limitations. The book covers honey's ethnomedicinal uses, chemical composition, and physical properties. It discusses the healing properties of honey, including antimicrobial, anti-inflammatory, and antioxidant properties. It also examines the botanical origin of honey, a critical factor in relation to its medicinal use, along with the complex subject of the varying composition of honey. Honey's antibacterial qualities and other attributes are described in a chapter dedicated to Leptospermum, or Manuka honey, a unique honey with potential for novel therapeutic applications. Chapters explore a variety of medicinal uses for honey, including its healing properties and use in burn and wound management. They review honey's beneficial effects on medical conditions, such as gastrointestinal disorders, cardiovascular diseases, diabetic ulcers, and cancers as well as in pediatrics and animal health and wellness. The book also examines honey-based formulations, modern methods for chemical analysis of honey, and the history and reality of "mad honey." The final chapters cover honey in the food industry, as a nutrient, and for culinary use.

The book provides an overview of current trends in biotechnology and medicinal plant sciences. The work includes detailed chapters on various advance biotechnological tools involved in production of phytoactive compounds of medicinal significance. Some recent and novel research studies on therapeutic applications of different medicinal plants from various geographical regions of the world have also been included. These studies report the antimicrobial activity of various natural plant products against various pathogenic microbial strains. Informative chapters on recent emerging applications of plant products such as source for nutraceuticals and vaccines have been integrated to cover latest advances in the field. This book also explores the conservation aspect of medicinal plants. Thus, chapters having comprehensively complied in vitro conservation protocols for various commercially important rare, threatened and endangered medicinal plants were provided in the present book.

Modified Cyclodextrins for Chiral Separation offers a review of the latest advances in developing modified cyclodextrins as chiral selectors for various chromatographic and electromigration techniques. Over the years, many descriptions of chiral separation have appeared in academic journals and books, but most of them have been devoted to either the development of analytical methods and protocols or the summary of different chiral selectors, including cyclodextrins for chiral separation applications. This is in marked contrast to this volume which focuses on the research endeavors concerning the development of cyclodextrin derivatives specifically as either chiral mobile phases for capillary electrophoresis, or chiral stationary phases for various chromatographic techniques including gas chromatography, or high-performance liquid chromatography and supercritical fluid chromatography. The ongoing thread in this book is the synthesis of structurally-defined cyclodextrin derivatives and their applications in enantiomer separation by means of different analytical techniques. Modified Cyclodextrins for Chiral Separation is intended for those who are interested in expanding their knowledge of cyclodextrin chemistry and chiral separation, and in what cyclodextrin modification can be made to suit the needs of chiral selectors for different analytical techniques. It primarily focuses on the state-of-the-art cyclodextrin chemistry which is the basis for all chiral selectors used in these chiral separation techniques. Weihua Tang, PhD, is a professor at the Key Laboratory of Soft Chemistry and Functional Materials, Ministry of Education, Nanjing University of Science and Technology, China. Siu-Choon Ng, PhD, is a professor at the Division of Chemical and Biomedical Engineering, School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore. Dongping Sun, PhD, is a professor at the Key Laboratory of Soft Chemistry and Functional Materials, Ministry of Education, Nanjing University of Science and Technology, China.

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

The blurring of boundaries between hitherto distinct scientific disciplines, technologies or markets is a common and powerful phenomenon. Subjects of this convergence often change consumer behaviours, favouring products and platforms with multiple functions. The Anticipation of Converging Industries provides a detailed focus on the triggers, drivers and consequences of convergence to create a more concise definition of convergence. This detailed analysis includes a specifically developed toolbox for 'convergence foresight', creating a forecasting method for convergence trends. With the focus on the chemical, biotechnological and pharmaceutical industries, several indicators of convergence in the areas of Nutraceuticals/Functional Foods, Cosmeceuticals and ICT are derived from samples including over 1million patents and scientific publications. By supporting this methodical approach with real world data, The Anticipation of Converging Industries is perfect for industry practitioners looking for a competitive edge in the present and for the future. Similarly, academics will find a comprehensive theoretical concept for better understanding the underlying rationale of convergence at their disposal

Renowned experts give all essential aspects of the techniques and applications of graft copolymers based on polysaccharides. Polysaccharides are the most abundant natural organic materials and polysaccharide based graft copolymers are of great importance and widely used in various fields. Natural polysaccharides have recently received more attention due to their advantages over synthetic polymers by being non-toxic, biodegradable and available at low cost. Modification of polysaccharides through graft copolymerization improves the properties of polysaccharides. Grafting is known to improve the characteristic properties of the backbones. Such properties include water repellency, thermal stability, flame resistance, dye-ability and resistance towards acid-base attack and abrasion. Polysaccharides and their graft copolymers find extensive applications in diversified fields. Applications of modified polysaccharides include drug delivery devices, controlled release of fungicides, selective water absorption from oil-water emulsions, purification of water etc.

This book investigates the relationship between phytoconstituents and properties in specific plants, such as Hibiscus rosa sinesis, Cuscuta reflexa, Citrullus colocynthis, Nardostachys jatamansi and Ocimum gratissimum, that are used in hair care products including shampoos, conditioners, dyes, and oils. It explains the impact of these materials on the growth, structure, appearance, and health of hair. It also explores how the chemistry of certain plants from sustainable sources is exploited for use in hair products and nutraceuticals. Additionally, the authors include information on ingredients used for formulating 'green' hair products that treat common conditions such as canities, dandruff and alopecia.

Discussing existing techniques, ongoing research, new approaches, and basic concepts in the treatment of nail diseases, Topical Nail Products and Ungual Drug Delivery summarizes the current knowledge and represents a jumping-off point for creating novel techniques of drug delivery across the nail. A growing area of pharmaceutical research, the search for efficient delivery techniques that can cross the nail barrier has yielded several effective strategies, brought together in this book. Topics Include Nail anatomy, physiology, diseases, and treatment Permeability of the nail plate Topical nail formulations Approaches to enhance ungual and trans-ungual drug delivery In vitro and in vivo models to evaluate topical nail formulations Nail sampling techniques Bioengineering of the nail Trans-ungual iontophoresis Pharmacokinetics of drugs in the nail apparatus Onychopharmacokinetics: proposed model insight Photodynamic therapy of nail diseases The nail as a surrogate for investigating drug use

Dendrimers are repeatedly branched and roughly spherical large molecules. They can be used in various medical applications, such as anticancer polymeric nanomedicines and nanocarriers, gene carriers and vectors in gene delivery, contrast agents for molecular imaging and vaccines against infectious diseases and cancer. The highly branched, multivalent nature and molecular architecture of dendrimers make them ideal tools for a variety of tissue engineering applications. This book describes different categories of dendrimers, their biomedical and physico-chemical applications as well as convergent and divergent syntheses, click chemistry and ligation strategies. It is a rich source of information for researchers in biochemistry and pharmacology working on drug development as well as for organic chemists who are engaged in synthesis of dendrimers.

This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the "lessons learnt" and "future developments".

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.

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

Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations-many of which will be nanoparticulates-can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.

Genome- and proteome-based research is generating a significant increase in the number of available drug targets. Correspondingly there is an increasing need for novel, diverse compounds, particularly based on natural compounds, as screening resource. The purpose of the Ernst Schering Research Foundation Workshop 51 was to provide a forum for an open exchange on perspectives and limitations of biocombinatorial synthesis and the significance of this technology for future drug discovery in light of this challenge. Experts from academia and industry provided contributions covering: the significance of natural compounds for state-of-the-art drug discovery; the underlying basic principle for the biosynthesis of highly complex compounds; and the scope and limitations of combinatorial biosynthesis regarding formation, identification, optimisation, isolation and manufacturing of novel biologically active entities.

Personalized medicine, which simply means selection of treatment best suited for an individual, involves integration and translation of several new technologies in clinical care of patients. The scope is much broader than indicated by the term genomic medicine because many non-genomic factors are taken into consideration in developing personalized medicine. Basic technologies for personalized medicine, of which molecular diagnostics has the biggest share, are mentioned briefly and appropriate references are given for further information. Commercial aspects are discussed briefly in a chapter and detailed analysis of markets and companies involved in personalized medicine is presented in a special report on this topic. There is increasing interest in personalized medicine. Considerable advances have taken place in molecular biology and biotechnology to make personalized medicine a viable option, but some misconceptions still exist, both in the academic and commercial sectors. There is lack of a suitable source of information that provides both the fundamentals as well as applications of personalized medicine. As the latest version of the first monograph on personalized medicine published in 1998, this volume, Textbook of Personalized Medicine, summarizes the author's efforts during the past decade, as well as reviews selected studies done during this period in a readable format for the physicians and scientists. It is hoped that physicians, pharmacists, scientists and interested lay readers with basic scientific knowledge will find this book useful.