With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors' decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.

Algal and sustainable technologies: Bioenergy, Nannotechnology and Green chemistry is an interdisciplinary overview of the world’s major problems; water scarcity, clean environment and energy and their sustenance remedy measures using microalgae. It comprehensively presents the way to tackle the socio-economic issues including food, feed, fuel, medicine and health and also entails the untapped potential of microalgae in environmental management, bioenergy solution and sustainable synthesis of pharmaceutical and nutraceutical products. This book basically emphasizes the success of algae as wonderful feed stocks of future and provides upto date information and sustainable and recreational outlook towards degrading environment and energy crisis. Applicability of fast emerging algae based nanotechnology in bioremediation and production of nanoparticle (AuNP, AgNP etc) are beautifully described along with latest research and findings. Key features: The "waste to best to income" strategies are the main concern of the book and take the edge off the problem of pollution, energy and income. Elucidate the sustainable phycoremediation and nanoparticle functions as low cost approach for various ecosystem services. Information regarding pharmaceuticals, nutraceuticals and other algae based value added product synthesis and fate are comprehensively discussed. Knowledge resource, latest research, findings and prospects presented in an accessible manner for researchers, students, eminent scientists, entrepreneurs, professionals and policy maker.

This book addresses the recent trends and clinical research being reported in last 5 to 10 years in the field of nasal drug delivery systems. In recent years, interest in using nasal passage as drug absorption site has received increased attention from formulation scientists. Nasal passages, even though a small surface area of the body as compared to other absorption passage such as Gastrointestinal tract or skin,  show significant possibility for drug absorption at a quicker rate. There is also a possibility of delivering drugs to the brain using this passage and targeting drugs through the nasal passage. The book has 19 chapters addressing various aspects of nasal drug delivery systems such as an overview of anatomy and physiology of the nasal passage from a drug delivery point of view to global market opportunities for nasal drug delivery. In between, it addresses various aspects of nasal drug delivery. There are very few titles exclusively dedicated to nasal drug delivery, covering the formulation and developmental aspects, and addressing the challenges and solutions. The primary audiences for the book are graduate students in field of medicine, pharmacy and also various researchers who are working in the area of nasal drug delivery in addition to students who are specializing in field of medicine in ENT. This book provides comprehensive information on all the aspects related to the nasal drug delivery of various drug molecules.

Organic chemistry research has moved rapidly toward synthesis and medicinal application of nitrogen-containing compounds such as triazenes, triazines, and hydroxytriazenes due to their excellent biological activities. Many of them are presently in clinical trials. Triazene compounds have excellent medicinal properties and limited toxicity. Hydroxytriazenes are excellent chelating agents for transition metals. Newer studies show very promising biological and medicinal applications of these classes of compounds. Hydroxytriazenes and Triazenes: The Versatile Framework, Synthesis, and Medicinal Applications highlights synthetic methods, recent advances, and potential applications of triazines, triazenes, and hydroxytriazenes. This book includes holistic information on synthetic methods for novel compounds based on this moiety, up-to-date information on the how and why of their diverse or even multitargeted medicinal application, and future state of the art of both aspects. Other features include: Highlights recent advances and diverse possible applications of biological functions Covers the chemistry of triazine, triazene, and hydroxytriazene systems On the basis of in silico predictions, the book highlights synthetic methods and their applications A valuable source of information for those actively engaged in medicinal chemistry, drug discovery, and synthetic organic chemistry

The world's ever increasing use of plastics has created large areas of floating plastic waste in the oceans-so-called plastic soup. This floating plastic debris is gradually fragmenting into smaller particles which eventually become microplastics, and even nanoplastics. Analysis of Nanoplastics and Microplastics in Food compiles data on nanoplastics and microplastics in food. To date, there is some data on this, particularly for the marine environment. Fish show high concentrations, but because microplastics are mostly present in the stomach and intestines, they are usually removed and consumers are not exposed. But in crustaceans and bivalve molluscs like oysters and mussels, the digestive tract is consumed, so there is some exposure. Microplastics have also been reported in honey, beer, and table salt. Key Features: Discusses sampling and analysis of nano- and microplastics Details the impacts of plastic residues in diverse compartments of the environment Includes a discussion of microplastics in freshwater Discusses interactions of microplastics and POPs This book brings to light the reality-and dangers-of microplastics in food. Pollutants like polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs) can accumulate in microplastics. Some studies suggest that, after consuming microplastics in food, these substances may transfer into tissues. So, it is important to estimate the average intake. Since engineered nanoparticles (from different types of nanomaterials) can enter human cells, this reality can pose consequences for human health. Also available in the Food Analysis and Properties Series: Mass Spectrometry Imaging in Food Analysis, edited by Leo M. L. Nollet (ISBN: 978-1-138-37069-2) Proteomics for Food Authentication, edited by Leo M. L. Nollet and Semih tles (ISBN: 978-0-367-20505-8) Food Aroma Evolution: During Food Processing, Cooking, and Aging, edited by Matteo Bordiga and Leo M. L. Nollet (ISBN: 978-1-138-33824-1) For a complete list of books in this series, please visit our website at: www.crcpress.com/Food-Analysis--Properties/book-series/CRCFOODANPRO

The concept of the 3Rs (Refinement, Reduction and Replacement) has been used as a framework for improving the welfare of laboratory animals for the last half century. By establishing an animal-centric view on housing and management, Animal-centric Care and Management: Enhancing Refinement in Biomedical Research takes Russell and Burch's definition of Refinement as "elimination of inhumanities" and goes further. Rather than fitting animals into experimental conditions, it encourages readers to adjust conditions to better meet the behavioral, emotional, physical, and physiological needs and preferences of the animals. The team of expert authors, from the fields of laboratory animal science, ethology, biology as well as animal training, provide ideas for creating housing conditions and handling procedures that induce, to the best of current abilities and knowledge, a long-term positive state of mind in the animals under our care. This book is written for animal caretakers, animal health technicians, researchers, animal facility managers, laboratory animal veterinarians, and anyone who engages in work with living experimental animals or is interested in the continuous improvement of laboratory animal welfare. This interdisciplinary guide will act as a catalyst, resulting in multiple viewpoints and fields collaborating to optimize laboratory animal welfare.

The concept of the 3Rs (Refinement, Reduction and Replacement) has been used as a framework for improving the welfare of laboratory animals for the last half century. By establishing an animal-centric view on housing and management, Animal-centric Care and Management: Enhancing Refinement in Biomedical Research takes Russell and Burch's definition of Refinement as "elimination of inhumanities" and goes further. Rather than fitting animals into experimental conditions, it encourages readers to adjust conditions to better meet the behavioral, emotional, physical, and physiological needs and preferences of the animals. The team of expert authors, from the fields of laboratory animal science, ethology, biology as well as animal training, provide ideas for creating housing conditions and handling procedures that induce, to the best of current abilities and knowledge, a long-term positive state of mind in the animals under our care. This book is written for animal caretakers, animal health technicians, researchers, animal facility managers, laboratory animal veterinarians, and anyone who engages in work with living experimental animals or is interested in the continuous improvement of laboratory animal welfare. This interdisciplinary guide will act as a catalyst, resulting in multiple viewpoints and fields collaborating to optimize laboratory animal welfare.

The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy. Dictionary of Pharmaceutical Dosage Forms is a collection of terms and definitions prepared to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care. It can also provide reference material for hospital and medical staff, consultants, nursing instructors, and pharmaceutical science students. This first edition classifies and organizes the forms in an easily readable format, so readers will find it a quick and simple reference. Features Collects terms and definitions to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care Focuses on product dosage forms and includes supplementary information, providing readers, particularly pharmacy and medical students and professionals, insights into choices of dosage forms made during drug product development Offers information on the indications, contraindications, side effects, and more, for a given drug Classifies and organizes the forms in a readable format, providing a quick and simple reference

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

This book provides the latest information on the significance of zebrafish as an ideal model for researching the biomedical field, with references. This book also focused on the evidence of zebrafish as a model in cardiovascular, neurologic, psychiatric and metabolic research. In addition, the book also includes the research carried out on zebrafish in hepatic, renal, ophthalmic, and ENT related areas. Contributed chapters come from the most prominent laboratories working in this field, which provides a unique perspective on zebrafish models from a wide spectrum of the research community. In addition, the book offers a detailed analysis of the most current research in the area for specific zebrafish models including specific research in the area of skin disorders, endocrine diseases, nutritional disorders, gastrointestinal, hematological disorders and cancer. The compilation of chapters in the volume culminates into a comprehensive and definitive text on zebrafish and its suitability for modeling various diseases, providing a critical resource on the potential attributes of the zebrafish as a pharmacological model. In terms of scope, this book is a useful tool for young researchers, professors and pharmaceutical scientists for understanding the significance of zebrafish as an emerging pharmacological model that can significantly aid in the process of drug discovery and development.

This book covers the essentials of drug delivery research and provides a unique forum for scientific experimental methods that are exclusively focused by the in-vitro, ex-vivo, and in-vivo methodologies of drug delivery research and felicitates translational research. The book includes recent and novel approaches in evaluation methods of transdermal, nasal, ocular, oral and intraoral, gastro-retentive, colon-targeted, and brain-targeted drug delivery systems. Providing up to date and comprehensive information, this text is invaluable to students, teachers, scientists, and others employed in the field of drug delivery.

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: * Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies * Authors from different major pharmaceutical and biotechnology companies * Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

This timely book provides a succinct summary of methods for the synthesis of bioactive heterocycles using a multicomponent reaction (MCR) approach. The majority of pharmaceuticals and biologically active agrochemicals are heterocycles while countless additives and modifiers used in industrial applications are heterocyclic in nature. With the recent introduction of high-throughput biological evaluation, the importance of MCRs for drug discovery has been recognized and considerable efforts have been focused especially on the design and development of multi-component procedures for the generation of various bioactive heterocycles due to their significant therapeutic potential.

In this era of finite budgets, healthcare rationing, medication shortages, and the global aging and burgeoning of populations, numerous stakeholders in the healthcare arena must understand the basic principles of pharmacoeconomics and how these may be correctly applied to facilitate drug development, rationing, patient segmentation, disease management, and pricing model development. Pharmacoeconomics: From Theory to Practice, Second Edition focuses on how to more efficiently and rationally leverage these healthcare resources, not by restricting access to necessary services, but by using them more efficiently. This updated volume arms decision makers with the tools they need to make wise choices in an area where the stakes are extremely high-the health of the global population. Key Features: Introduces the major concepts and principles of Pharmacoeconomics Gives updated information about pharmacoeconomic models, value-based pricing, novel modelling methodologies and international utilization of these modalities in government, the pharmaceutical industry, and health care settings Demonstrates the full range of ethical and moral issues, as well as overall public health and commercial concerns that are often involved in decisions entailing pharmacoeconomic issues Presents both theory and methodology discussions, including real-world examples, in each chapter 'The methods and application of pharmacoeconomics are rapidly evolving, so the new edition of this textbook is very timely. It provides an excellent introduction for those new to the field, whether they be students, professionals within the pharmaceutical industry, or health care professionals more generally. A particularly useful feature of the book is that it gives an introduction both to the main methods used in pharmacoeconomics studies and how these studies are used in decisions about the reimbursement or appropriate use of medicines in several countries.' - Michael Drummond, Professor of Health Economics, University of York

In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of lipid-based and inorganic nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. The materials discussed include liposome-scaffold systems, elastic liposomes, targeted liposomes, solid lipid nanoparticles, lipoproteins, exosomes, porous inorganic nanomaterials, silica nanoparticles, and inorganic nanohybrids. The book provides all available information about them and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully.

Piper betle (betel vine) a pan-Asiatic, tropical plant, which can also grow under mild subtropical areas, is essentially grown for leaves which are chewed with array of additives besides slaked lime. The plant is cultivated widely in India and its surrounding areas. Phytochemistry of Piper betel landraces presents a brief on the distribution, historical and cultural aspects, and properties ascribed to this plant in the ancient texts. Phytochemical and pharmacological information has also been included to underscore the importance of this plant in the present time. A detailed account on metabolic profiling employing modern methods is included, such as real-time, direct analysis of the flight mass spectrometric method and chemometric analysis for characterization of the available biodiversity and signatures specific to gender and geographical location. It was also possible to identify the gender of unknown landraces, with the help of principal component analysis. Features: Elaborates on the chemical diversity within Piper betle. Piper betle leaves have mouth freshening antimicrobial compounds. Use of chemical signatures for the identification of different Piper betle landraces, their gender and geographical locations.

This book covers the latest developments and advances in spray drying and describes how they impact the basic aspect of designing and operating spray dryers. This generic approach allows users to understand how different basic aspects of spray drying have advanced. Users will learn how to apply these advances in their own specific spray drying applications. This book also discusses the handling and control of spray dried products. Includes the latest techniques for use in the design and operation of spray drying operations Covers the basic operations of spray drying that can be applied to different applications of spray drying Discusses the handling and control of spray dried product qualities from a general approach, allowing readers to tailor these approaches to their own specific products This book is aimed at professionals, researchers, and academics working in the fields of food, chemical, pharmaceutical, and industrial engineering.

The microfluidic lab-on-a-chip allows scientists to conduct chemical and biochemical analysis in a miniaturized format so small that properties and effects are successfully enhanced, and processes seamlessly integrated. This microscale advantage translates into greater sensitivity, more accurate results, and better information. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery focuses on all aspects of the microfluidic lab-on-a-chip technologies and offers an overview of the available technology, its limitations, and its breakthroughs over the years. It emphasizes analytical applications of microfluidic technology and offers in-depth coverage of micromachining methods, microfluidic operations, chemical separations, sample preparation and injection methods, detection technology, and various chemical and biological analyses. Other topics of interest include the use of polymeric chips, fluid flow valve and control, single-cell analysis, DNA and RNA amplification techniques, DNA hybridization, immunoassays and enzymatic assays. Originally conceived as a single chapter published in Ewing's Analytical Instrumentation, this book is a gateway to the vast literature and conference proceedings on the topic. Microfluidic Lab-on-a-Chip for Chemical and Biological Analysis and Discovery expands upon its roots to present a comprehensive treatment of microfluidic lab-on-a-chip methods and applications for novices and advanced researchers alike.

This book is the first to provide both a broad overview of the current methodologies being applied to drug design and in-depth analyses of progress in specific fields. It details state-of-the-art approaches to pharmaceutical development currently used by some of the world's foremost laboratories. The book features contributors from a variety of fields, new techniques, previously unpublished data, and extensive reference lists.

Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data. Top biostatisticians from academia, biopharmaceutical industries, and government agencies discuss how these advances are impacting clinical trials and biomedical research. Divided into three parts, the book begins with an overview of interval-censored data modeling, including nonparametric estimation, survival functions, regression analysis, multivariate data analysis, competing risks analysis, and other models for interval-censored data. The next part presents interval-censored methods for current status data, Bayesian semiparametric regression analysis of interval-censored data with monotone splines, Bayesian inferential models for interval-censored data, an estimator for identifying causal effect of treatment, and consistent variance estimation for interval-censored data. In the final part, the contributors use Monte Carlo simulation to assess biases in progression-free survival analysis as well as correct bias in interval-censored time-to-event applications. They also present adaptive decision making methods to optimize the rapid treatment of stroke, explore practical issues in using weighted logrank tests, and describe how to use two R packages. A practical guide for biomedical researchers, clinicians, biostatisticians, and graduate students in biostatistics, this volume covers the latest developments in the analysis and modeling of interval-censored time-to-event data. It shows how up-to-date statistical methods are used in biopharmaceutical and public health applications.

Ocimum species has been used as a traditional remedy for various ailments such as arthritis, bronchitis, cold, conjunctivitis, diarrhea, dysentery, and flatulence, as well as for healing wounds and lowering blood glucose level. These are characterized by variations in their morphology such as the shape, size and pigmentation of leaves, which cause differences in chemical composition and affect the commercial value of this genus. This book describes phytochemical investigations of Ocimum species using LC-MS/MS instruments to study qualitative and quantitative variations of phytochemicals in different Ocimum species. Features: Collection of Ayurvedic features and scientific analytical and pharmacological evidence of most important medicinal plants of genus Ocimum. Chemical signatures for the identification of Ocimum species. Easy-to-use analytical procedure for quality control of plants of Ocimum species and its herbal products.

Piper is the representative genus of family Piperaceae. Piper species are pan-tropical in distribution and found in both the hemispheres. As the king of all spices, black pepper, Piper nigrum, led to the global expeditions culminating in the discovery of India and the new world. Piper species have been reported to possess various pharmacological activities such as insecticidal, antibacterial, anti-inflammatory, antiplatelet, anti-hypertensive, antithyroid, antitumor activities and hepatoprotective properties. Botanical authentication of the plants of Piper species is difficult because of the morphological similarity among the species. This book describes ultra-performance liquid chromatography coupled with triple quadrupole electrospray tandem mass spectrometry in multiple reactions monitoring (MRM) mode to study the quantitative variation of thirteen bioactive markers in different plant parts of ten Piper species. Features: Collection of Ayurvedic features and scientific evidence of the most important medicinal plants of Piper species. Describes chemical signatures for identification of Piper species. Provides easy-to-use analytical procedure for quality control of Piper species and its products.

Fluorescence of Living Plant Cells for Phytomedicine Preparations reveals how valuable medicinal compounds can be identified through the application of vital fluorescence in plant cells. The book explains the roles that fluorescent compounds play in plant physiology and promotes our knowledge of plant secretory cells and phytopreparations. Supported by vivid illustrations, the book reveals how actinic light - light that induces fluorescence in leaves and flowers - can be used in the identification of secretory cells within plant tissue that may be the repository of valuable medicinal compounds. The book demonstrates the potential of fluorescence in pharmacological analysis with detailed methods for applying fluorescence to identify these deposits of natural drugs. As such, this groundbreaking book contains methods of express-pharmaceutical analysis that could open new horizons in pharmacy and the cultivation of medicinal plants. Features Describes various fluorescence microscopy techniques for the localization of compounds contained in plants with pharmaceutical interest Provides an analysis of pharmaceutical material based on autofluorescence and histochemical reactions for numerous medicinal plant species Demonstrates practices for providing optimal growing conditions and improving the quality of the compounds Showing the readiness of plant raw material for pharmaceutical industry, this book will appeal to professionals in the pharmaceutical industry and students and researchers in the fields of phytochemistry, botany and pharmaceutical sciences.

Rauvolfia species, commonly known as Sarpagandha, has been traditionally used in Ayurveda for curing high blood pressure, hypertension, snake bites, fever, and mental illnesses. Due to its wide variety and differences in chemical composition, it is necessary to develop an efficient and reliable method for rapid screening and determination of phytochemicals in the extracts of the Rauvolfia species. This book will provide qualitative and quantitative comparative phytochemical investigations of selected medicinal plants from the Rauvolfia genus using liquid chromatography-mass spectrometry (LC-MS) techniques. The results will help in assuring the efficacy and safety of Rauvolfia herbal products. Features: Collection of Ayurvedic features and scientific evidence of important medicinal plants. Discusses chemical signatures for the identification of Rauvolfia (Sarpagandha) and its products. Easy-to-use analytical procedure for quality control of Rauvolfia and its products.