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.

Tinospora cordifolia stem is used as a tonic, vitalizer, and as a remedy for metabolic disorders to treat allergies, diabetes, dysentery, jaundice, heart diseases, leprosy, rheumatoid arthritis, skin diseases, and urinary disorders. It shows anti-inflammatory, analgesic, antipyretic actions and immunosuppressive effects. This book focuses on providing gender and geographical location-based differences in the phytoconstituents of T. cordifolia by the liquid chromatography mass spectrometric method. These methods have potential use in the quality control of T. cordifolia and the screening of herbal preparations. Features: Compilation of ayurvedic features of one of the most important plants of the Indian system of medicines. Useful for all ayurvedic practitioners, researchers, faculty, students, and herbal product manufacturers. Application of advance hyphenated LC-MS techniques for variation study in phytoconstituents.

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.

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.

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.

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.

There is a dramatic rise of novel drug use due to the increased popularity of so-called designer drugs. These synthetic drugs can be illegal in some countries, but legal in others and novel compounds unknown to drug chemistry emerge monthly. This thoughtfully constructed edited reference presents the main chromatographic methodologies and strategies used to discover and analyze novel designer drugs contained in diverse biological materials. The methods are based on molecular characteristics of the drugs belonging to each individual class of compounds, so it will be clear how the current methods are adaptable to future new drugs that appear in the market.

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.

Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes. Bioseparations-also called downstream processing- can be a key source of competitive advantageto biopharmaceutical developers. Process Scale Bioseparations for the Biopharmaceutical Industry brings together scientific principles, empirical approaches, and practical considerations for designing industrial downstream bioprocesses for various classes of biomolecules. Using clear language along with numerous case studies, examples, tables, flow charts, and schematics, the book presents perspectives from experienced professionals involved in purification processes and industrial downstream unit operations. The authors provide useful experimental design strategies and guidelines for developing application-specific process scale bioseparations. Chapter topics include harvest by centrifugation and filtration, expanded bed chromatography, protein refolding, modes of preparative chromatography, methodologies for resin screening, membrane chromatography, protein crystallization, viral filtration, ultrafiltration/diafiltration, implementing post-approval downstream process changes for an antibody product, and future trends. Ideal for both new and experienced scientists in the biopharmaceutical industry and students, Process Scale Bioseparations for the Biopharmaceutical Industry is a comprehensive resource for all topics relevant to industrial process development.

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.

Used routinely in drug control laboratories, forensic laboratories, and as a research tool, thin layer chromatography (TLC) plays an important role in pharmaceutical drug analyses. It requires less complicated or expensive equipment than other techniques, and has the ability to be performed under field conditions. Filling the need for an up-to-date, complete reference, Thin Layer Chromatography in Drug Analysis covers the most important methods in pharmaceutical applications of TLC, namely, analysis of bulk drug material and pharmaceutical formulations, degradation studies, analysis of biological samples, optimization of the separation of drug classes, and lipophilicity estimation. The book is divided into two parts. Part I is devoted to general topics related to TLC in the context of drug analysis, including the chemical basis of TLC, sample pleparation, the optimization of layers and mobile phases, detection and quantification, analysis of ionic compounds, and separation and analysis of chiral substances. The text addresses the newest advances in TLC instrumentation, two-dimensional TLC, quantification by slit scanning densitometry and image analysis, statistical processing of data, and various detection and identification methods. It also describes the use of TLC for solving a key issue in the drug market-the presence of substandard and counterfeit pharmaceutical products. Part II provides an in-depth overview of a wide range of TLC applications for separation and analysis of particular drug groups. Each chapter contains an introduction about the structures and medicinal actions of the described substances and a literature review of their TLC analysis. A useful resource for chromatographers, pharmacists, analytical chemists, students, and R&D, clinical, and forensic laboratories, this book can be utilized as a manual, reference, and teaching source.

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.

Several Phyllanthus species are widely used in traditional medicine and herbal formulation for the treatment of a variety of ailments such as flu, dropsy, diabetes, jaundice and bladder calculus. The medicinal properties of these species are due to the presence of lignans, flavonoids, tannins, alkaloids and terpenoids. Phyllanthin and hypophyllanthin are the major lignans from Phyllanthus species having estrogenic properties that reduce toxicity and vascular tension, and protect hepatocytes. This book deals with the importance of separation techniques in screening of major lignans, flavonoids and terpenoids in Phyllanthus species using HPLC/UPLC coupled with mass spectrometric techniques. Features: Collection of Ayurvedic features and scientific evidence of important medicinal plants. Screening of major lignans, flavonoids and terpenoids in plant parts/whole plant extracts and their geographical variations in Phyllanthus amarus. Easy-to-use analytical procedure for the quality control of Phyllanthus and its products.

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.

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.

Plant volatiles-compounds emitted from plant organs to interact with the surrounding environment-play essential roles in attracting pollinators and defending against herbivores and pathogenes, plant-plant signaling, and abiotic stress responses. Biology of Plant Volatiles, with contributions from leading international groups of distinguished scientists in the field, explores the major aspects of plant scent biology. Responding to new developments in the detection of the complex compound structures of volatiles, this book details the composition and biosynthesis of plant volatiles and their mode of emission. It explains the function and significance of volatiles for plants as well as insects and microbes whose interactions with plants are affected by these compounds. The content also explores the biotechnological and commercial potential for the manipulation of plant volatiles. Features: Combines widely scattered literature in a single volume for the first time, covering all important aspects of plant volatiles, from their chemical structures to their biosynthesis to their roles in the interactions of plants with their biotic and abiotic environment Takes an interdisciplinary approach, providing multilevel analysis from chemistry and genes to enzymology, cell biology, organismal biology and ecology Includes up-to-date methodologies in plant scent biology research, from molecular biology and enzymology to functional genomics This book will be a touchstone for future research on the many applications of plant volatiles and is aimed at plant biologists, entomologists, evolutionary biologists and researchers in the horticulture and perfume industries.

Analytical ultracentrifugation (AUC) can supply rich information on the mass, shape, size distribution, solvation, and composition of macromolecules and nanoscopic particles. It also provides a detailed view of their reversible single- or multi-component interactions over a wide range of affinities. Yet this powerful technique has been hard to master in mainstream molecular sciences due to a lack of comprehensive books on the subject. Filling this gap in the literature of biophysical methodology, Basic Principles of Analytical Ultracentrifugation explains the fundamentals in the theory and practice of AUC. The book provides you with up-to-date experimental information to confidently practice AUC. You will understand the basic concepts, full potential, and possible pitfalls of AUC as well as appreciate the current relevance of past work in the field. The book first introduces the basic principles and technical setup of an AUC experiment and briefly describes the optical systems used for detection. It then explores the ultracentrifugation experiment from a macromolecular standpoint, offering a detailed physical picture of the sedimentation process and relevant macromolecular parameters. The authors present important practical aspects for conducting an experiment, including sample preparation, data acquisition and data structure, and the execution of the centrifugal experiment. They also cover instrument calibration and quality control experiments.

Recent Advancement in Prodrugs Drugs used as medicines have many limitations like low chemical stability, aqueous solubility, or oral absorption/bioavailability, rapid presystemic metabolism, toxicity, inadequate site specificity, or poor patient acceptance/compliance (unwanted adverse effects, unacceptable taste or odor, irritation or pain). Prodrugs design is an approach to overcome these limitations. Key features Covers recent advancements in development of prodrugs Presents balanced synthesis and applications of prodrug chemistry Discusses broad spectrum of prodrug categories and outlines industrial applications Reviews prodrugs in cancer nanomedicine, its therapy and treatment Elucidates mathematical models to study the kinetics of prodrugs This book covers recent advances in the design of prodrugs. It contains all the significant recent examples of prodrug chemistry developments and will aid academics and researchers seeking to generate new projects in the field.

1) Discusses the affordability of future therapy and the possible challenges for health insurance systems 2) Highlights the gradual move from repeated treatment administration to one single administration with potential for a definite cure 3) Describes the potential change of paradigm which will challenge all payers and may question the sustainability of our health care systems

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

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.