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.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

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.

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 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.

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.

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.

Biological and Pharmaceutical Applications of Nanomaterials presents the findings of cutting-edge research activities in the field of nanomaterials, with a particular emphasis on biological and pharmaceutical applications. Divided into four sections-nanomaterials for drug delivery, antimicrobial nanomaterials, nanomaterials in biosensors, and safety of nanomaterials-this book: Covers topics such as stimuli-responsive nanostructured silica matrixes, gold nanoparticles, and liposomes for targeting drug delivery and dental applications Describes the use of nanocarriers and nanoparticles as cancer and peptide therapeutics, the influence of surface characteristics on microbial adhesion, and the latest developments in antimicrobial nanostructured polymers for medical applications Discusses recent advances in nanodiagnostic techniques for infectious agents, chromogenic biosensors for pathogen detection, electrochemical biosensors for detecting DNA damage and genotoxicity, and molecular imaging with quantum dots including surface modifications by polymers for biosensing applications Featuring contributions from field experts and researchers in industry and academia, Biological and Pharmaceutical Applications of Nanomaterials provides state-of-the-art information on nanomaterials and their use in drug delivery, infection control, and biomedicine.

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.

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.

Biotechnology is a multidisciplinary field encompassing microbiology, bichemistry, genetics, molecular biology, chemistry, immunology, cell and tissue culture physiology. This book describes the recent developments in these areas. Current research topics such as Quorum sensing, Integrons, Phytomining are discussed, which would serve as an excellent reference work for both academicians and researchers in the field.

As a result of the Process Analytical Technologies (PAT) initiative launched by the U.S. Food and Drug Administration (FDA), analytical development is receiving more attention within the pharmaceutical industry. Illustrating the importance of analytical methodologies, Thermal Analysis of Pharmaceuticals presents reliable and versatile characterization tools for the successful development of pharmaceutical products. It draws attention to the most widely applicable methods and demonstrates how to interpret the associated data. The book opens with the first three chapters devoted to differential scanning calorimetry (DSC), the most commonly used thermal method. These chapters cover the principles, optimal use, and pharmaceutical applications of the method. Subsequent chapters explore modulated temperature DSC, thermogravimetric analysis, thermal microscopy, microcalorimetry, high sensitivity DSC, dynamic mechanical analysis, and thermally stimulated current, all of which have attracted great interest within the pharmaceutical field. The chapters include theoretical background, measurement optimization, and pharmaceutical applications of each technique. Exploring important techniques for characterizing the physical structure and properties of pharmaceutical materials, Thermal Analysis of Pharmaceuticals achieves an ideal balance in the depth, relevance, and accessibility of topics presented. The book provides an excellent overview of this key area in pharmaceutical development.

Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug

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.

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

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.

Pharmaceutical manufacturing was one of the first industries to recognize the importance of green chemistry, with pioneering work including green chemistry metrics and alternative solvents and reagents. Today, other topical factors also have to be taken into consideration, such as rapidly depleting resources, high energy costs and new legislation. This book addresses current challenges in modern green chemical technologies and sustainability thinking. It encompasses a broad range of topics covered by the CHEM21 project - Europe's largest public-private partnership project which aims to develop a toolbox of sustainable technologies for green chemical intermediate manufacture. Divided into two sections, the book first gives an overview of the key green chemistry tools, guidance and considerations aimed at developing greener processes, before moving on to look at cutting-edge synthetic methodologies. Featuring innovative research, this book is an invaluable reference for chemists across academia and industry wanting to further their knowledge and understanding of this important topic.

Natural Product Chemistry for Drug Discovery provides a comprehensive summary of where natural product chemistry is today in drug discovery. The book covers emerging technologies and case studies and is a source of up-to-date information on the topical subject of natural products. The authors, all experts in their respective fields, provide compelling arguments as to why naturel products should be considered important tools in the drug discovery process. The book will appeal across the board from scientists to professionals, postgraduates and industrial chemists. The case studies selected for inclusion highlight recently marketed drugs and development candidates that have been derived from natural products. These 'real-life' examples show how new technologies, such as advances in screening, isolation, dereplication and prefractionation, have significantly enhanced the discovery process.

The over-riding premise for biotechnology in this book is bringing novel products to market to substantially advance patient care and disease mitigation. Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is that, bringing biotech products to market for patient care involves success in the following four areas of engagement simultaneously - scientific advances for healthcare technologies, novel and varied products for untreated diseases, regulatory authorities, and biotech companies. Features Comprehensive coverage of biotechnology science topics used in development and manufacturing Addresses all the scientific technologies within biotechnology responsible for products on the market and the pipeline Presents business issues such as marketing and sales of the products, as well as companies engaged, and how biotech business has evolved

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: A perspective on the role of the intention-to-treat principle Examples and case studies from various areas Example code in SAS and R A connection with causal inference Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

Bioactive lipid metabolism and signaling are now widely accepted as major players in cancer biology. This volume helps to fill the urgent need to explore and investigate the innovations, current shortcomings, and future challenges of cancer therapy through the bioactive lipids by presenting new research on the use of bioactive lipids as effective weapons against cancer. The volume introduces the subject and then goes on to cover the chemistry, formulation, and mechanism of bioactive lipids in cancer. The volume takes a close look at lipoxins, ceramides, resolvins, and sphingosine-1-phosphate and their roles in cancer treatment. It also addresses the formulations based on bioactive lipids for the treatment of cancer. A variety of mechanisms of bioactive lipids as novel therapies are also covered, including using computational techniques to identify bioactive lipid drug targets, targeting therapy via KRAS and PI3K signals, and others. The authors also discuss the role and effects of various substances and their effect on various cancers, including colorectal cancer, prostate cancer, breast cancer, and others. The application of lysophosphatidic acid, lipopolysaccharide, lipid-soluble bioactive substance from avocado, omega-3 polyunsaturated fatty acids-derived lipid metabolites, and more are covered as well. The volume offers academia, technologists, and scientists from different disciplines valuable information to gain knowledge of bioactive lipid metabolism and signaling as an anti-cancer weapon in their fight against cancer.

Covers comprehensive overview of the neurological diseases associated with neurochemical imbalances. Provides a brief account of neurotransmission, as either a study or high-yield revision aid

Connecting past, present, and future instrument development and use, Biocalorimetry: Foundations and Contemporary Approaches explores biocalorimetry's history, fundamentals, methodologies, and applications. Some of the most prominent calorimeter developers and users share invaluable personal accounts of discovery, discussing innovative techniques as well as special and original applications. Wide in scope, the book also covers calorimetry use on membranes, nucleic acids, and proteins and addresses both thermodynamics and kinetics. The book begins with a look at the historical development of calorimeters needed for biological research. It then describes advanced approaches that use high-quality commercial calorimeters to study biochemical and other biological processes. It also shows how novel experimental designs and data analysis procedures are applied to proteins, DNA, membranes, and living matter.

Since the discovery of Aquaporin-1 (AQP1) as a water channel, many studies have revealed the importance of aquaporins in mammalian physiology and pathophysiology as well as plant and microbial biology. The studies have also shown aquaporins as potential drug targets and targets for improving crop properties. Written by an international group of contributors at the forefront of the field, Aquaporins in Health and Disease: New Molecular Targets for Drug Discovery presents the latest research advances in aquaporins and other major intrinsic protein (MIP) channels. The first section of the book describes the general concepts of aquaporin channel function, genomic research, structure-function analysis of aquaporins and glycerol facilitators, and regulation by gating and trafficking, including yeast aquaporin regulation and function. The second section discusses the physiological and pathophysiological roles of aquaporins in humans and microbes. The final section covers the development of inhibitors of aquaporin function. The book's epilogue offers future perspectives and directions, mainly in the area of aquaporin-based diagnostics and therapeutics. Stimulating future research on this important protein family, this book facilitates a paradigm shift in the understanding and roles of aquaporin membrane proteins in all biological settings. It encourages scientists to develop novel approaches for the treatment of human diseases based on aquaporin function or dysfunction.

Covering the whole area of process chemistry in the pharmaceutical industry, this monograph provides the essential knowledge on the basic chemistry needed for future development and key industrial techniques, as well as morphology, engineering and regulatory compliances.
Application-oriented and well structured, the authors include recent examples of excellent industrial production of active pharmaceutical ingredients.