In a living body, a variety of molecules are working in a concerted manner to maintain its life, and to carry forward the genetic information from generation to generation. A key word to understand such processes is "water," which plays an essential role in life phenomena. This book sheds light on life phenomena, which are woven by biomolecules as warp and water as weft, by means of statistical mechanics of molecular liquids, the RISM and 3D-RISM theories, both in equilibrium and non-equilibrium. A considerable number of pages are devoted to basics of mathematics and physics, so that students who have not majored in physics may be able to study the book by themselves. The book will also be helpful to those scientists seeking better tools for the computer-aided-drug-discovery. Explains basics of the statistical mechanics of molecular liquids, or RISM and 3D-RISM theories, and its application to water. Provides outline of the generalized Langevin theory and the linear response theory, and its application to dynamics of water. Applies the theories to functions of biomolecular systems. Applies the theories to the computer aided drug design. Provides a perspective for future development of the method.

Bioprocess Engineering for a Green Environment examines numerous bioprocesses that are crucial to our day-to-day life, specifically the major issues surrounding the production of energy relating to biofuels and waste management. The nuance of this discussion is reflected by the text's chapter breakdown, providing the reader with a fulsome investigation of the energy sector; the importance of third-generation fuels; and the application of micro- and macroalgae for the production of biofuels. The book also provides a detailed exploration of biocatalysts and their application to the food industry; bioplastics production; conversion of agrowaste into polysaccharides; as well as the importance of biotechnology in bio-processing. Numerous industries discharge massive amounts of effluents into our rivers, seas, and air systems. As such, two chapters are dedicated to the treatment of various pollutants through biological operation with hopes of achieving a cleaner, greener, environment. This book represents the most comprehensive study of bioprocessing-and its various applications to the environment-available on the market today. It was furthermore written with various researchers in mind, ranging from undergraduate and graduate students looking to enhance their knowledge of the topics presented to scholars and engineers interested in the bioprocessing field, as well as members of industry and policy-makers. Provides a comprehensive overview of bioprocesses that apply to day-to-day living. Is learner-centered, providing detailed diagrams for easy understanding. Explores the importance of biocatalysts and their applications to the food industry, as well as bioplastics production. Examines the unique capabilities of bioprocess engineering and its ability to treat various pollutants. .

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

This book discusses fabrication of functionalized gold nanoparticles (GNPs) and multifunctional nanocomposites, their optical properties, and applications in biological studies. This is the very first book of its kind to comprehensively discuss published data on in vitro and in vivo biodistribution, toxicity, and uptake of GNP by mammalian cells providing a systematization of data over the GNP types and parameters, their surface functionalization, animal and cell models. As distinct from other related books, Gold Nanoparticles in Biomedical Applications discusses the immunological properties of GNPs and summarizes their applications as an antigen carrier and adjuvant in immunization for the preparation of antibodies in vivo. Although the potential of GNPs in nanobiotechnology has been recognized for the past decade, new insights into the unique properties of multifunctional nanostructures have recently emerged. With these developments in mind, this book unites ground breaking experimental data with a discussion of hybrid nanoparticle systems that combine different nanomaterials to create multifunctional structures. These novel hybrids constitute the material basis of theranostics, bringing together the advanced properties of functionalized GNPs and composites into a single multifunctional nanostructure with simultaneous diagnostic and therapeutic functions. Such nanohybrids can be physically and chemically tailored for a particular organ, disease, and patient thus making personalized medicine available.

The field of ethics in science aims to improve the way the audience perceives science, and this unique workbook discusses the areas of ethics and scientific misconduct. It provides assessments and exercises for learners to work through in groups or alone. Completion of the workbook but especially the assessment and tests will earn the learner a certificate for scientific misconduct training compiled by the author, and the certificate is available from the author's own website. This volume is a companion to the author's published volume, Ethics in Science: Ethical Misconduct in Scientific Research, Second Edition and will appeal to undergraduates, graduates and even high school students. Features: A unique training workbook in ethics and good conduct, easliy accessible and user friendly Unlike books in this area which mostly cover the theoretical foundations of ethics in science, here the author provides a practical workbook and ancillaries Case studies and a PowerPoint presentation are provided and readers will receive a certificate of completion There is a wealth of instructor resources available from the homepage A knowledge of scientific misconduct is of utmost importance in an era of mass higher education

Molecular farming is a biotechnological approach that includes the genetic adjustment of agricultural products to create proteins and chemicals for profitable and pharmaceutical purposes. Plant molecular farming describes the manufacture of recombinant proteins and other biologically active product in plants. This approach depends on a genetic transformation of plants that can be accomplished by the methods of stable gene transfer, such as gene transfer to nuclei and chloroplasts, and unstable transfer methods like viral vectors. The requirement for recombinant proteins in terms of quality, quantity, and diversity is increasing exponentially This demand is traditionally met by recombinant protein construction technologies and the engineering of orthodox expression systems based on bacteria or mammalian cell cultures. However, majority of developing countries cannot afford the high costs of medicine derived from such existing methods. Hence, we need to produce not only the new drugs but also the cheaper versions of those already present in the market. Plant molecular farming is considered as a cost-effective technology that has grown and advanced tremendously over the past two decades. This book summarizes the advances and challenges of plant molecular farming for all those who are working on or have an interest in this rapidly emerging area of research.

Who wins the race to turn molecules into medicines? How much does it cost? What factors influence the choice of synthetic routes and reaction mechanisms? How can pharmaceutical companies protect their discoveries? In From Bench to Market, Walter Cabri and Romano Di Fabio chart the process of industrial chemical synthesis, from the first discovery of a molecule to its entry in the marketplace as a drug. Using real case histories of drug development from several therapeutic areas, they discuss all aspects related to the process research for bulk production, including comparison between different synthetic routes, key methodologies and reaction mechanisms, costs, patent competition, and crystalline forms.

Mass Spectrometry in Drug Discovery summarizes the theory, instrumentation, techniques, and application of mass spectrometry and atmospheric pressure ionization to screening, evaluating, and improving the performance and quality of drug candidates. It provides time- and cost-efficient approaches for the generation and analysis of effective pharmaceuticals, covers advances in combinatorial chemistry, molecular biology, bioanalysis automation, and computing, and demonstrates the use of mass spectrometry in the assessment of disease states, drug targets, and potential drug agents.

Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

This volume contains the proceedings of the Ninth Meeting of the "International Study Group for Tryptophan Research" (lSTRY), held at the University of Hamburg, Germany, from October 10 to 14, 1998. At this meeting the recent developments in the field of tryptophan research were presented by leading researchers from all over the world in 81 oral and 48 poster contri butions. Research on tryptophan and its derivatives provides an inexhaustible subject. At the conference we tried to compose a multifacetted picture of the recent investiga tions through contributions from the major disciplines involved. Thus, we tried to strike a balance between basic research topics and clinical, nutritional or industrial applica tions. We offered workshops on tryptophan (in sleep and mood), melatonjn, IDO-acti vation and the eosinophilia-myalgia syndrome (EMS) as a platform for intensive discussion for the participants. In these proceedings many contributions are multidisciplinary and have practical or theoretical implications for different research fields. Hence, we have organized this volume in nine main chapters according to basic disciplines and subjects. We are aware that this classification is artificial, but we hope that it is the best compromise for contributors and readers."

Pharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.

Natural products play an integral and ongoing role in promoting numerous aspects of scientific advancement, and many aspects of basic research programs are intimately related to natural products. The significance, therefore, of the Studies in Natural Product Chemistry series, edited by Professor Atta-ur-Rahman, cannot be overestimated. This volume, in accordance with previous volumes, presents us with cutting-edge contributions of great importance.

Nanotechnology Based Approaches for Tuberculosis Treatment discusses multiple nanotechnology-based approaches that may help overcome persisting limitations of conventional and traditional treatments. The book summarizes the types of nano drugs, their synthesis, formulation, characterization and applications, along with the most important administration routes. It also explores recent advances and achievements regarding therapeutic efficacy and provides possible future applications in this field. It will be a useful resource for investigators, pharmaceutical researchers, innovators and scientists working on technology advancements in the areas of targeted therapies, nano scale imaging systems, and diagnostic modalities in tuberculosis.

This volume focuses on the potential use of probiotics in treating metabolic disorders such as diabetes mellitus, metabolic acidosis, and gut dysbiosis. Chapters draw an association between gut microbiota and its diversity with metabolic diseases like diabetes, obesity, related liver and gut disorders; gut-brain axis; increased inflammation, and a compromised immune system resulting from these manifestations and scope of intervention with probiotics. Special attention is laid on describing the mechanisms of action of such beneficial effects of probiotic administration. The ability of probiotics to decrease metabolic endotoxemia by restoring the disrupted intestinal mucosal barrier is also included. The volume is a comprehensive compilation describing the scope and application of probiotic and prebiotic therapy in treating metabolic disorders. Readers will discover how probiotics are not just confined to the microbiology industry but are showing promising results in the medical and pharmaceutical sectors.

Drug Discovery Targeting Drug-Resistant Bacteria explores the status and possible future of developments in fighting drug-resistant bacteria. The book covers the majority of microbial diseases and the drugs targeting them. In addition, it discusses the potential targeting strategies and innovative approaches to address drug resistance. It brings together academic and industrial experts working on discovering and developing drugs targeting drug-resistant (DR) bacterial pathogens. New drugs active against drug-resistant pathogens are discussed, along with new strategies being used to discover molecules acting via new modes of action. In addition, alternative therapies such as peptides and phages are included. Pharmaceutical scientists, microbiologists, medical professionals, pathologists, researchers in the field of drug discovery, infectious diseases and microbial drug discovery both in academia and in industrial settings will find this book helpful.

We're all familiar with the idea that plant-derived chemicals can have an impact on the functioning of the human brain. Most of us reach for a cup of coffee or tea in the morning, many of us occasionally eat some chocolate, some smoke a cigarette or take an herbal supplement, and some people use illicit drugs. We know a great deal about the mechanisms by which the psychoactive components of these various products have their effects on human brain function, but the question of why they have these effects has been almost totally ignored. This book sets out to describe not only how, in terms of pharmacology or psychopharmacology, but more importantly why plant- and fungus-derived chemicals have their effects on the human brain. The answer to this last question resides, in part, with the terrestrial world's two dominant life forms, the plants and the insects, and the many ecological roles the 'secondary metabolite' plant chemicals are trying to play; for instance, defending the plant against insect herbivores whilst attracting insect pollinators. The answer also resides in the intersecting genetic heritage of mammals, plants, and insects and the surprising biological similarities between the three taxa. In particular it revolves around the close correspondence between the brains of insects and humans, and the intercellular signaling pathways shared by plants and humans. Plants and the Human Brain describes and discusses both how and why phytochemicals affect brain function with respect to the three main groups of secondary metabolites: the alkaloids, which provide us with caffeine, a host of poisons, a handful of hallucinogens, and most drugs of abuse (e.g. morphine, cocaine, DMT, LSD, and nicotine); the phenolics, including polyphenols, which constitute a significant and beneficial part of our natural diet; and the terpenes, a group of multifunctional compounds which provide us with the active components of cannabis and a multitude of herbal extracts such as ginseng, ginkgo and valerian.

Pharmaceutical Applications of Dendrimers explores the applications of dendrimers in the solubilization of hydrophobic active ingredients, drug delivery, gene delivery, imaging, diagnosis and photodynamic therapy. The book discusses the diagnostic applications of dendrimers, including their use as MRI contrast agents and in the imaging of diseased areas. In addition, the anti-inflammatory, antimicrobial and antiviral properties of PPI and PAMAM are also covered, along with a discussion on photosensitizers, such as rose Bengal and protoporphyrin IX that have been delivered using PAMAM and PPI dendrimers for the treatment of cancer. This book is an important research reference for those who want to learn more about the development of dendrimer-based solutions for drug delivery.

Contents:
Part 1 Identifying the issues: control of microbial contamination in cosmetics, toiletries and non-sterile pharmaceuticals; hazards associated with the microbiological contamination of cosmetics, toiletries and pharmaceuticals. Part 2 Control in manufacture: microbiological control of raw materials; control of microbial contamination during manufacture. Part 3 Control through preservation: natural and physical preservative systems; the effect of container materials and multiple phase formulation components on the activity of antimicrobial agents; formulation aspects of the preservation of skin and hair products; preservation of solid oral dosage forms; development of preservative systems; microbial resistance to preservative systems; safety evaluation of preservatives. Part 4 Microbiological control - methods and standards: preservative efficacy testing of pharmaceuticals, cosmetics and toiletries and its limitations; challenge tests and their predictive ability; new methodology for microbial quality assurance; microbial contamination of manufactured products - official and unofficial limits.

D ring the past ten ears or so, there has been an increasing n mber of p blications describing ario s aspects of oligon cleotide chemistr and the application of oligon cleotides in basic, as ell as applied science. More recentl , ario s oligon cleotide conj gates nthesi ed that are c rrentl being st died for their ha e been s potential diagnostic and therape tic applications. With the introd- tion of ne oligon cleotide conj gates, anal tical methods for the anal sis of these oligon cleotides are also being de eloped and op- mi ed. The present ol me, Protocols for Oligon cleotide Con- gates: S nthesis and Anal tical Techniq es, is designed to bring readers p-to-date on the protocols for the s nthesis of ario s oli- gates and on all the important techniq es for the n cleotide conj nthetic oligon cleotides and their analogs. The s- anal sis of s thetic chemistrof man of these oligon cleotides and their ario s analogs has been co ered in a companion ol me entitledProtocols for Oligon cleotides and Analogs: S nthesis and Properties. The first chapter ofProtocols for Oligon cleotide Conj gates- scribes the protecting gro ps in oligon cleotide s nthesis.

Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.

Dynamic Treatment Regimes: Statistical Methods for Precision Medicine provides a comprehensive introduction to statistical methodology for the evaluation and discovery of dynamic treatment regimes from data. Researchers and graduate students in statistics, data science, and related quantitative disciplines with a background in probability and statistical inference and popular statistical modeling techniques will be prepared for further study of this rapidly evolving field. A dynamic treatment regime is a set of sequential decision rules, each corresponding to a key decision point in a disease or disorder process, where each rule takes as input patient information and returns the treatment option he or she should receive. Thus, a treatment regime formalizes how a clinician synthesizes patient information and selects treatments in practice. Treatment regimes are of obvious relevance to precision medicine, which involves tailoring treatment selection to patient characteristics in an evidence-based way. Of critical importance to precision medicine is estimation of an optimal treatment regime, one that, if used to select treatments for the patient population, would lead to the most beneficial outcome on average. Key methods for estimation of an optimal treatment regime from data are motivated and described in detail. A dedicated companion website presents full accounts of application of the methods using a comprehensive R package developed by the authors. The authors' website www.dtr-book.com includes updates, corrections, new papers, and links to useful websites.

With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

The vast and exciting Brazilian flora biodiversity is still underexplored. Several research groups are devoted to the study of the chemical structure richness found in the different Biomes. This volume presents a comprehensive account of the research collated on natural products produced from Brazilian medicinal plants and focuses on various aspects of the field. The authors describe the key natural products and their extracts with emphasis upon sources, an appreciation of these complex molecules and applications in science. Many of the extracts are today associated with important drugs, nutrition products, beverages, perfumes, cosmetics and pigments, and these are highlighted. Key Features: Presents Brazilian biodiversity: its flora, its people, and its research Describes the emergence of natural products research in Brazil Emphasizes the increasing global interests in botanical drugs Aids the international natural product communities to better understand the herbal resources in Brazil Discusses Brazilian legislation to work with native plants

Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.

This volume provides an insight into the future strategies for commercial biocatalysis with a focus on sustainable technologies, together with chemoenzymatic and biotechnological approaches to synthesize various types of approved and new active pharmaceutical ingredients (APIs) via proven and latest synthetic routes using single-step biocatalytic or enzyme cascade reactions. Many of these drugs act as enzyme inhibitors, as discussed in a chapter with a variety of examples. The targeted enzymes are involved in diseases such as different cancers, metastatic and infectious diseases, osteoporosis, and cardiovascular disorders. The biocatalysts employed for API synthesis include hydrolytic enzymes, alcohol dehydrogenases, laccases, imine reductases, reductive aminases, peroxygenases, cytochrome P450 enzymes, polyketide synthases, transaminases, and halogenases. Many of them have been improved with respect to their properties by engineering methods. The book discusses the syntheses of drugs, including alkaloids and antibiotics, non-ribosomal peptides, antimalarial and antidiabetic drugs, prenylated xanthones, antioxidants, and many important (chiral) intermediates required for the synthesis of pharmaceuticals.