Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture. The first edition of this book was the first to be wholly devoted to the subject. The second edition was revised to mirror growth and development in areas where the design remained in widespread use and new areas where it had grown in importance. This new Third Edition: Contains seven new chapters written in the form of short case studies that address re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept, and recalculating the sample size using conditional power Employs the R package Crossover, specially created to accompany the book and provide a graphical user interface for locating designs in a large catalog and for searching for new designs Includes updates regarding the use of period baselines and the analysis of data from very small trials Reflects the availability of new procedures in SAS, particularly proc glimmix Presents the SAS procedure proc mcmc as an alternative to WinBUGS for Bayesian analysis Complete with real data and downloadable SAS code, Design and Analysis of Cross-Over Trials, Third Edition provides a practical understanding of the latest methods along with the necessary tools for implementation.

Drug Discovery with Privileged Building Blocks traces back PharmaBlock's founding philosophy of designing privileged building blocks. High-quality building blocks are crucial not only to biological activities of different molecules but also to ADMET properties, which eventually will impact the success rate of drug discovery projects. A thorough study of how building blocks perform in drug molecules and a regular analysis of new building block structures in the latest researches have proven to be a fruitful strategy to generate novel building blocks. Using this strategy, PharmaBlock has supplied the drug industry with a great number of building blocks, which are increasingly being adopted by drug hunters, and these are identified in this book. Each chapter may be read and studied without learning the previous chapters. This book will be a good starting point for novice medicinal chemists, and veteran medicinal chemists will find it useful as well. Key Feature The book covers privileged building blocks appearing most frequently on patents for novel drugs. The latest relevant tactics are explained in the context of drug design and medicinal chemistry. Key synthesis, especially large-scale synthesis, is described. The most recent literature references are cited.

Drug Discovery with Privileged Building Blocks traces back PharmaBlock's founding philosophy of designing privileged building blocks. High-quality building blocks are crucial not only to biological activities of different molecules but also to ADMET properties, which eventually will impact the success rate of drug discovery projects. A thorough study of how building blocks perform in drug molecules and a regular analysis of new building block structures in the latest researches have proven to be a fruitful strategy to generate novel building blocks. Using this strategy, PharmaBlock has supplied the drug industry with a great number of building blocks, which are increasingly being adopted by drug hunters, and these are identified in this book. Each chapter may be read and studied without learning the previous chapters. This book will be a good starting point for novice medicinal chemists, and veteran medicinal chemists will find it useful as well. Key Feature The book covers privileged building blocks appearing most frequently on patents for novel drugs. The latest relevant tactics are explained in the context of drug design and medicinal chemistry. Key synthesis, especially large-scale synthesis, is described. The most recent literature references are cited.

This book details the novel nanocarriers named 'invasomes" and how they are used for dermal and transdermal drug delivery. The text describes their composition, usage of skin as a drug delivery route and liposomes as skin delivery systems. Included are reviewed studies revealing the importance of invasomes in this field.

Updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods, Fifth Edition supplies new chapters on topics currently impacting the field including cutaneous metabolism, skin contamination, exposure to protein allergens, in vitro absorption methodology and the percutaneous absorption of chemical mixtures. Complete with studies on the role of the skin as a key portal of entry for chemicals into the body, this book serves as a detailed reference source for recent advances in the field, as well as an experimental guide for laboratory personnel. Key Features: Details in vivo and in vitro methods for measuring absorption, dermal decontamination, mechanisms of transdermal delivery, and the relationship of transepidermal water loss to percutaneous absorption Considers a range of mathematical models, the safety evaluation of cosmetic ingredients, the absorption of hair dyes, nanoparticles for drug delivery, and other novel methods of drug delivery Discusses topics including skin metabolism, the skin reservoir, and the effects of desquamation on absorption

Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.

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

A contribution to the series on Natural Products Chemistry of Global Plants, Natural Products Chemistry of Botanical Medicines from Cameroon focuses on the sources and chemistry of natural products from plants in Cameroon, West Africa. The plants selected offer an opportunity to trace a route through history from ancient civilizations to the modern day, showing the important value to man of natural products in medicines and in foods. This book highlights how many of the extracts from Cameroon are today associated with important drugs, nutrition products, beverages, perfumes, cosmetics and pigments, as well as presenting their complex chemistry and structure. Key Features: Forms an important part of the series on Natural Products Chemistry of Global Plants, as Cameroon is a country with rich experience in the use of medicinal plants and with a wide diversity of botanical resources Addresses the current development of pharmacognosy research in Cameroon Provides readers with updated information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers an extensive range of chemical, botanical and pharmacological diversities Xavier Siwe Noundou is a Scholar/Scientist based at Rhodes University in Grahamstown, South Africa. He has been a EU FP7 Marie Curie Fellow (2015-2016), Kaposvar University in Hungary (2015, 2016), Trakia Univesity in Bulgaria (2016), TWAS Fellow (2013), National Research Foundation South Africa Fellow (2014-2016). Dr Noundou works on Medicinal Chemistry focusing on Chemistry, Pharmacognosy and Nanotechnology. His main research interests include terrestrial natural products chemistry (from Cameroon and South Africa) and marine natural products chemistry (from the South African coastline): bioactive metabolites isolated as potential antiparasitic, antimicrobial, antiviral and antiproliferative candidates. He is author of more than forty scientific publications in his field of expertise.

Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of hand-made botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

Phylogenetic presentation of medicinal plants and a chemotaxonomical rationale of antiviral, antibacterial, and antifungal action. Discusses chemical structure-activity relationship, pharmacokinetics, and oral bioavailability of antimicrobial principles Introduces the molecular mechanism of natural products on viruses, bacteria, and fungi. Contains a selection of hand-made botanical plates and useful bibliographic references A useful research tool for postgraduates, academics, and the pharmaceutical, herbal, or nutrition industries.

The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached $2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/ analyses such as the Bayesian approach are essential to meet this need. This book will be the first to provide comprehensive coverage of Bayesian applications across the span of drug development, from discovery, to clinical trial, to manufacturing with practical examples. This book will have a wide appeal to statisticians, scientists, and physicians working in drug development who are motivated to accelerate and streamline the drug development process, as well as students who aspire to work in this field. The advantages of this book are: Provides motivating, worked, practical case examples with easy to grasp models, technical details, and computational codes to run the analyses Balances practical examples with best practices on trial simulation and reporting, as well as regulatory perspectives Chapters written by authors who are individual contributors in their respective topics Dr. Mani Lakshminarayanan is a researcher and statistical consultant with more than 30 years of experience in the pharmaceutical industry. He has published over 50 articles, technical reports, and book chapters besides serving as a referee for several journals. He has a PhD in Statistics from Southern Methodist University, Dallas, Texas and is a Fellow of the American Statistical Association. Dr. Fanni Natanegara has over 15 years of pharmaceutical experience and is currently Principal Research Scientist and Group Leader for the Early Phase Neuroscience Statistics team at Eli Lilly and Company. She played a key role in the Advanced Analytics team to provide Bayesian education and statistical consultation at Eli Lilly. Dr. Natanegara is the chair of the cross industry-regulatory-academic DIA BSWG to ensure that Bayesian methods are appropriately utilized for design and analysis throughout the drug-development process.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Summarizes signaling pathways regulated by redox reactions Reveals how redox pathways affect cancer and tumor cell metastasis Chapters by an internationals team of leading researchers Chapters describe redox regulation influences developmental processes and these processes originated even before there was much oxygen in the atmosphere

The advanced AI techniques are essential for resolving various problematic aspects emerging in the field of bioinformatics. This book covers the recent approaches in artificial intelligence and machine learning methods and their applications in Genome and Gene editing, cancer drug discovery classification, and the protein folding algorithms among others. Deep learning, which is widely used in image processing, is also applicable in bioinformatics as one of the most popular artificial intelligence approaches. The wide range of applications discussed in this book are an indispensable resource for computer scientists, engineers, biologists, mathematicians, physicians, and medical informaticists. Features: Focusses on the cross-disciplinary relation between computer science and biology and the role of machine learning methods in resolving complex problems in bioinformatics Provides a comprehensive and balanced blend of topics and applications using various advanced algorithms Presents cutting-edge research methodologies in the area of AI methods when applied to bioinformatics and innovative solutions Discusses the AI/ML techniques, their use, and their potential for use in common and future bioinformatics applications Includes recent achievements in AI and bioinformatics contributed by a global team of researchers

A contribution to the series on Natural Products Chemistry of Global Plants, Natural Products Chemistry of Botanical Medicines from Cameroon focuses on the sources and chemistry of natural products from plants in Cameroon, West Africa. The plants selected offer an opportunity to trace a route through history from ancient civilizations to the modern day, showing the important value to man of natural products in medicines and in foods. This book highlights how many of the extracts from Cameroon are today associated with important drugs, nutrition products, beverages, perfumes, cosmetics and pigments, as well as presenting their complex chemistry and structure. Key Features: Forms an important part of the series on Natural Products Chemistry of Global Plants, as Cameroon is a country with rich experience in the use of medicinal plants and with a wide diversity of botanical resources Addresses the current development of pharmacognosy research in Cameroon Provides readers with updated information on the chemistry and pharmacology of natural products with pharmaceutical potential Covers an extensive range of chemical, botanical and pharmacological diversities Xavier Siwe Noundou is a Scholar/Scientist based at Rhodes University in Grahamstown, South Africa. He has been a EU FP7 Marie Curie Fellow (2015-2016), Kaposvar University in Hungary (2015, 2016), Trakia Univesity in Bulgaria (2016), TWAS Fellow (2013), National Research Foundation South Africa Fellow (2014-2016). Dr Noundou works on Medicinal Chemistry focusing on Chemistry, Pharmacognosy and Nanotechnology. His main research interests include terrestrial natural products chemistry (from Cameroon and South Africa) and marine natural products chemistry (from the South African coastline): bioactive metabolites isolated as potential antiparasitic, antimicrobial, antiviral and antiproliferative candidates. He is author of more than forty scientific publications in his field of expertise.

Medicinal Chemistry: A Look at How Drugs Are Discovered is written for those who are interested in learning how drugs are discovered. Compared to other books on the market, this text takes a different approach by presenting the subject on chemical reaction mechanism terms, which ideally makes the subject matter more interesting and easier to comprehend. The authors describe the drug discovery process, from advancing an initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on chemical mechanism terms, allowing for a more interesting and easier to comprehend text Includes valuable insights toward the various pathways taken at pharmaceutical industries in drug discoveries Improved by including questions raised and suggestions made from students in the authors' medicinal chemistry classes This book will benefit both upper level undergraduates and graduates studying in the fields of medicinal chemistry and drug discovery, as well as scientists working in the pharmaceutical industry.

This new volume looks at the applications of biomarkers as important tools for herbal drug discovery, presenting research on phytoconstituents with advanced nanotechnological applications for healthcare benefits. Herbal drug discovery based on biomarkers is an emerging area in complementary and alternative medicine that has tremendous potential in healthcare. Conventional medications have limited efficacy and high toxicity, whereas herbal drugs are said to provide wide structural diversity that is not usually seen with conventional/synthetic drug molecules. Recognition of various herbal constituents, such as terpenoids, fatty acids, flavonoids and steroids, are well explored in the management and treatment of various disorders in this volume. These agents target various biomarkers such as nitric oxide (NO), cytokines, chemokines, adhesion molecules, NF- k , lipoxygenase (LOX), and arachidonic acid. Biomarkers as Targeted Herbal Drug Discovery: A Pharmacological Approach to Nanomedicines discusses phytoconstituent-based nanotherapeutics with applications for some specific health issues, such as arthritis, leishmanicidal, cardiovascular diseases, cancer, ocular disorders, etc.

Covers recent research on the following aspects of vitamin B12: structure, constitution, properties, nomenclature, organometallic reactivity, usage in diagnosis and therapy, and role in biological systems Discusses the chemistry of the carbon cobalt bond Is illustrated throughout with excellent figures and references in each chapter

An introductory but detailed treatise which includes some 1,000 references and solved examples and end-of-chapter problems, making it useful to both students and practitioners. The pharmokinetics, pharmacodynamics, and biological and biopharmaceutical parameters pertinent to each route of administra

Provides an understanding of (mostly) enzymatic reactions that are responsible for the function and maintenance of living things This innovative text for non-biochemistry majors includes introductory material at the beginning of each chapter that contextualizes chapter themes in real-life scenarios Online supporting materials with further opportunities for research and investigation Synthesis questions at the end of each chapter that encourage students to make connections between concepts and ideas, as well as develop critical-thinking skills

Discusses endogenous benzodiazepine-like substances - what do they do, do they affect the anti-anxiety drugs and their adverse effects? Presents information on the enigmatic prolonged benzodiazepine withdrawal syndrome Describes the compounds acting at the BDZ binding sites, both exogenous (classical BDZ drugs and BDZ from food and plants) and endogenous (endozepines) Assesses the putative interactions in physiology, pathology and pharmacology of the compounds acting at the BDZ binding sites

Discusses endogenous benzodiazepine-like substances - what do they do, do they affect the anti-anxiety drugs and their adverse effects? Presents information on the enigmatic prolonged benzodiazepine withdrawal syndrome Describes the compounds acting at the BDZ binding sites, both exogenous (classical BDZ drugs and BDZ from food and plants) and endogenous (endozepines) Assesses the putative interactions in physiology, pathology and pharmacology of the compounds acting at the BDZ binding sites

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

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.

Plant diseases are a serious threat to food production. This unique volume provides the fundamental knowledge and practical use of B.subtilis as a promising biocontrol agent. In order to replace chemical pesticides, one possibility is microbial pesticides using safe microbes. Bacillus subtilis is one of several candidates. Screening of the bacterium, the application of plant tests, clarification of its suppressive mechanism to plant pathogens and engineering aspects of suppressive peptides production are presented here. The author illustrates how B. subtilis is far more advantageous than, for example, Pseudomonas in biocontrol and can be considered as an useful candidate. Features: Bacterium B. subtilis suppresses many plant pathogens and is a biocontrol agent to replace chemical pesticides The book presents the bacterium's suppressive mechanism to plant pathogens, and engineering aspects of suppressive peptides production Biological control of plant disease plays an important role in sustainable agricultural production practices and is expected to replace agricultural chemicals