A comprehensive treatment of the science, technology, and regulation of rate-controlled administration of therapeutic agents, with coverage of the basic concepts, fundamental principles, biomedical rationales, and potential applications. This revised and updated edition (first in 1982) incorporates

Introduction, Historical Highlights, and the Need for Dissolution Testing Theories of Dissolution Dissolution Testing Devices Automation in Dissolution Testing, by William A. Hanson and Albertha M. Paul Factors That Influence Dissolution Testing Interpretation of Dissolution Rate Data Techniques and of In Vivo Dissolution, by Umesh V. Banakar, Chetan D. Lathia, and John H. Wood Dissolution of Dosage Forms Dissolution of Modified-Release Dosage Forms Dissolution and Bioavailability Dissolution Testing and the Assessment of Bioavailability/Bioequivalence, by Santosh J. Vetticaden Dissolution Rediscovered, by John H. Wood Appendix: USP/NF Dissolution Test.

Sample Sizes for Clinical Trials, Second Edition is a practical book that assists researchers in their estimation of the sample size for clinical trials. Throughout the book there are detailed worked examples to illustrate both how to do the calculations and how to present them to colleagues or in protocols. The book also highlights some of the pitfalls in calculations as well as the key steps that lead to the final sample size calculation. Features: Comprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data Covers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs Highlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study Motivated with examples of real-life clinical trials showing how the calculations can be applied New edition is extended with all chapters revised, some substantially, and four completely new chapters on multiplicity, cluster trials, pilot studies, and single arm trials The book is primarily aimed at researchers and practitioners of clinical trials and biostatistics, and could be used to teach a course on sample size calculations. The importance of a sample size calculation when designing a clinical trial is highlighted in the book. It enables readers to quickly find an appropriate sample size formula, with an associated worked example, complemented by tables to assist in the calculations.

This book provides the pharmaceutical formulator with the fundamental understanding necessary to prepare efficacious topical drug delivery formulations that have both chemical and physical stability and that are cosmetically acceptable and preferably cosmetically elegant.

The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

Combinatorial chemistry and molecular diversity approaches to scientific inquiry and novel product R&D have exploded in the 1990s! For example, in the preparation of drug candidates, the automated, permutational, and combinatorial use of chemical building blocks now allows the generation and screening of unprecedented numbers of compounds. Drug discovery - better, faster, cheaper? Indeed, more compounds have been made and screened in the 1990s than in the last hundred years of pharmaceutical research. This first volume covers: (i) combinatorial chemistry, (ii) combinatorial biology and evolution, and (iii) informatics and related topics. Within each section chapters are prepared by experts in the field, including, for example, in Section I: Coverage of mixture pools vs. parallel individual compound synthesis, solution vs. solid-phase synthesis, analytical tools, and automation. Section II highlights selection strategies and library-based evolution, phage display, peptide and nucleic acid libraries. Section III covers databases and library design, high through-put screening, coding strategies vs. deconvolutions, intellectual property issues, deals and collaborations, and successes to date.

The revised and up-to-date third edition of Drug Interactions in Infectious Diseases delivers a text that will enhance your clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The third edition features five new chapters that cover material not addressed in previous editions. These new chapters describe interactions with a number of drug classes such as non-HIV antiviral, antimalarial, antiparasitic, antihelmintic, macrolide, azalide and ketolide agents. A novel chapter on probe cocktail studies has been included to highlight an important research tool for drug development. These chapters address material that cannot be retrieved easily in the medical literature. The highly acclaimed food-drug interactions as well as the study design and analysis chapters remain definitive references. The newly written drug-cytokine interaction highlights the need for our improved understanding of the complex interrelationship of acute infection, inflammation, and the risk of drug interactions. Informative tables on specific drug-drug interactions are provided throughout the chapters as a quick clinical resource. The Third Edition of Drug Interactions in Infectious Diseases is a distillation of relevant drug interactions associated with antimicrobials, infection, and inflammation. This concise review of the mechanisms and strategies to manage drug interactions should be valuable to all health care practitioners. Features * Definitive reference source of up-to-date information on antimicrobial drug interactions * Informative tables on the degree of interaction for specific antimicrobial agents * In-depth discussion of mechanisms and potential mechanistic pathways of interaction * New chapters on non-HIV antiviral, antimalarial, antiparasitic, and macrolide, azalide and ketolide agents * New chapter on probe-cocktail studies as a research tool to study drug-drug interactions * Inclusion of new antimicrobial agents and their associated drug interactions * First rate chapters on study design and analysis, and drug-food interactions * A fresh perspective on drug-cytokine interactions * Authoritative chapter on regulatory considerations of drug interactions during drug development

This volume contains the proceedings of the Ninth International Symposium on Cyclodextrins, held in Santiago de Compostela, Spain, May 31 - June 3, 1998. The papers collected represent a summary of the last two years' achievements in the application of cyclodextrins in such diverse fields as pharmaceuticals, biotechnology, textiles, chromatography and environmental sciences. Highlights: Chiral selection of chemicals, nuclear waste management, cyclodextrins in nasal drug delivery, cyclodextrins in pulmonary drug delivery, cyclodextrins as pharmaceutical excipients, pharmacokinetics, stabilization of drugs by cyclodextrins, structural characterization of cyclodextrin complexes by nuclear magnetic resonance and molecular modeling, artificial receptors, large cyclodextrins, cyclodextrins as enzyme models, new cyclodextrin derivatives and potentials. Audience: This book will be of interest to researchers whose work involves biotechnology, pharmaceuticals, food and chemicals and chromatographic methods, as well as fundamental cyclodextrin research.

"Biofilm Eradication and Prevention"s presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem. Split into three parts, the first deals with the development and characterization of biofilm on the surfaces of implanted or inserted medical devices. Questions as to why biofilms form over medical device surfaces and what triggers biofilm formation are addressed. In the second section, the author discusses biofilm-mediated chronic infections occurred in various organs (eyes, mouth, wounds) and pharmaceutical and drug delivery knowledge gained from research in these area. The third part explores pharmaceutical approaches like lipid-and polymer-based drug delivery carriers for eradicating biofilm on device-related infections. In addition, this section also explores the topic of novel small molecule (like iron and its complexes/metal chelators) and a quorum-sensing inhibitors to control medical biofilm formation.

A reference is needed that addresses the recent progress in aspects of PK/PD methods and developments of nanoparticles for novel drug delivery systems. No other consolidated published reference discusses the PK/PD study of nanoparticle drug delivery systems. This book discusses the advantages of nanoparticle drug delivery systems (NPDDS) in enhancing the pharmacokinetics of many drugs that are not easily metabolized or that obtain the desired therapeutic effect with minimum toxicity. The authors provide an overview of biodistribution with a focus on polymer and lipid nanoparticles. This thorough reference is divided into three parts: Modelling, Specific carries and their potential to treat specific diseases.

The first review describes examples of very promising compounds discovered from plants acquired from Africa, Southeast Asia, the Americas, and the Caribbean region with potential anticancer activity. These include plant secondary metabolites of the diphyllin lignan, penta[b]benzofuran, triterpenoid, and tropane alkaloid types. The second review presents 40 more erythrinan alkaloids, which were either new or were missed out in the last major reviews, bringing to a total of 154 known erythrinan alkaloids known to date. The reported pharmacological activities of the new and known alkaloids showed a greater bias towards central nervous system and related activities. Other prominent activities reported were antifeedant or insecticidal, cytotoxicity/anti tumor/anti cancer/estrogenic, antiprotozoal, antiinflammatory, antioxidant, antifungal and antiviral activities.

This book reviews the challenges and opportunities posed by flow chemistry in drug discovery, and offers a handy reference tool for medicinal chemists interested in the synthesis of biologically active compounds. Prepared by expert contributors, the respective chapters cover not only fundamental methodologies and reactions, such as the application of catalysis, especially biocatalysis and organocatalysis; and non-conventional activation techniques, from photochemistry to electrochemistry; but also the development of new process windows, processes and reactions in drug synthesis. Particular attention is given to automatization and library synthesis, which are of great importance in the pharmaceutical industry. Readers will also find coverage on selected topics of general interest, such as how flow chemistry is contributing to drug discovery R&D in developing countries, and the green character of this enabling technology, for example in the production of raw materials for the pharmaceutical industry from waste. Given its scope, the book appeals to medicinal chemistry researchers working in academia and industry alike, as well as professionals involved in scale-up and drug development.

Molecular similarity searching is fast becoming a key tool in organic chemistry. In this book, the editor has brought together an international team of authors, each working at the forefront of this technology, providing a timely and concise overview of current research. The chapters focus principally on those methods which have reached sufficient maturity to be of immediate practical use in molecular design.

This installment in the Techniques in Life Science and Biomedicine for the Non-Expert series aims to describe ESR spectroscopy as a tool for different applications, such as Healthcare & Pharmaceutical Science, Paleontology & Geochronology and Food Science. In keeping with the series theme, this text is presented in such a manner that the amateur researcher or graduate student can absorb it, while highlighting recent advances and applications of the field. Chapters include solved examples and questions to reinforce themes and encourage readers to apply what they've learnt.

This volume highlights natural products, molecular methods for identifying, and current trends in designing non-natural natural products. Chapters guide readers through protocols on heterologous expression techniques, gene disruption, modified pathway regulators, and in-vitro studies. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Engineering Natural Product Biosynthesis: Methods and Protocols aims to be a useful and practical guide to new researchers and experts looking to expand their knowledge. Chapter 13 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Honey typically has a complex chemical and biochemical composition that invariably includes complex sugars, specific proteins, amino acids, phenols, vitamins, and rare minerals. It is reported to be beneficial in the treatment of various diseases, such as those affecting the respiratory, cardiovascular, gastrointestinal, and nervous systems, as well as diabetes mellitus and certain types of cancers; however, there is limited literature describing the use of honey in modern medicine. This book provides evidence-based information on the pharmaceutical potential of honey along with its therapeutic applications and precise mechanisms of action. It discusses in detail the phytochemistry and pharmacological properties of honey, highlighting the economic and culturally significant medicinal uses of honey and comprehensively reviewing the scientific research on the traditional uses, chemical composition, scientific validation, and general pharmacognostical characteristics. Given its scope, it is a valuable tool for researchers and scientists interested in drug discovery and the chemistry and pharmacology of honey.

Recent developments in the field of nutrition have led to increased interest in herbs and medicinal plants as phytochemical-rich sources for functional food, nutraceuticals, and drugs. As research sheds light on the therapeutic potential of various bioactive phytochemicals, the demand for plant extracts and oils has increased. Black cumin or black seeds (Nigella sativa) have particularly widespread nutritional and medicinal applications. In traditional medicine, black seeds are used to manage fatigue and chronic headache. Black seed oil is used as an antiseptic and analgesic remedy and for treatment of joint's pain and stiffness and can be mixed with sesame oil to treat dermatosis, abdominal disorders, cough, headache, fever, liver ailments, jaundice, sore eyes, and hemorrhoids. Thymoquinone, the main constituent in black seed volatile oil, has been shown to suppress carcinogenesis. Black cumin (Nigella sativa) seeds: Chemistry, Technology, Functionality, and Applications presents in detail the chemical composition, therapeutic properties, and functionality of high-value oils, phytochemicals, nutrients, and volatiles of the Nigella sativa seed. Organized by formulation (seeds, fixed oil, essential oil, and extracts), chapters break this seed down into its chemical constituents and explore their role in the development of pharmaceuticals, nutraceuticals, novel food, natural drugs, and feed. Following numerous reports on the health-promoting activities of Nigella sativa, this is the first comprehensive presentation of the functional, nutritional, and pharmacological traits of Nigella sativa seeds and seed oil constituents.

S. Ren and E.J. Lien: CaCo-2 cell permeability vs human gastrointestinal absorption: QSPR analysis.- J.C.G. Halford and J.E. Blundell: Pharmacology of appetite suppression.- B. Olivier, W. Soudijn and I. van Wijngaarden: Serotonin, dopamine and norepinephrine transporters in the central nervous system and their inhibitors.- D. Poyner, H. Cox, M. Bushfield, J.M. Treherne and M.K. Demetrikopoulos: Neuropeptides in drug research.- M. Kumari and M.K. Ticku: Regulation of NMDA receptors by ethanol.- H. Horikoshi, T. Hashimoto and T. Fujiwara: Troglitazone and emerging glitazones: new avenues for potential therapeutic benefits beyond glycemic control.- Rosamund C. Smith and Simon J. Rhodes: Applications of developmental biology to medicine and animal agriculture

A suitable drug delivery system is an essential element in achieving efficient therapeutic responses of drug molecules. With this desirability in mind, the book unites different techniques through which extremely small-sized particles can be utilized as a successful carrier for curing chronic as well as life-threatening diseased conditions. This is a highly informative and prudently organized book, providing scientific insight for readers with an interest in nanotechnology. Beginning with an overview of nanocarriers, the book impetuses on to explore other essential ways through which these carriers can be employed for drug delivery to varieties of administrative routes. This book discusses the functional and significant features of nanotechnology in terms of Lymphatic and other drug targeting deliveries. The book is presenting depth acquaintance for various vesicular and particulate nano-drug delivery carriers, utilized successfully in Pharmaceutical as well as in Cosmeceutical industries along with brief information on their related toxicities. In addition, the work also explores the potential applications of nanocarriers in biotechnology sciences for the prompt and safe delivery of nucleic acid, protein, and peptide-based drugs. An exclusive section in the book illuminates the prominence and competent applicability of nanotechnology in the treatment of oral cancer. The persistence of this book is to provide basic to advanced information for different novel carriers which are under scale-up consideration for the extensive commercialization. The book also includes recent discoveries and the latest patents of such nanocarriers. The cutting-edge evidence of these nanocarriers available in this book is beneficial to students, research scholars, and fellows for promoting their advanced research.

Essentials of Industrial Pharmacy is an attempt to comprehensively present, in a single book, various pharmaceutical processes and equipment that are frequently used for production of pharmaceutical dosage forms, along with quality control tests of these dosage forms. Pictorial/graphical illustrations provide easier understanding of complex pharmaceutical concepts, manufacturing processes of pharmaceutical dosage forms. Since it is imperative for pharmacy students to have a clear understanding of the basic concepts used in development of drugs into suitable and stable dosage forms. This book offers a wealth of information regarding basic aspects of pharmaceutical processes and dosage forms, in a single book, for undergraduate pharmacy students or science students (with no pharmacy background) intended to work in the pharmaceutical Industry.

This volume begins with a short history of malaria and follows with a summary of its biology. It then traces the fascinating history of the discovery of quinine for malaria treatment, and then describes quinine's biosynthesis, its mechanism of action, and its clinical use, concluding with a discussion of synthetic antimalarial agents based on quinine's structure. It also covers the discovery of artemisinin and its development as the source of the most effective current antimalarial drug, including summaries of its synthesis and biosynthesis, its mechanism of action, and its clinical use and resistance. A short discussion of other clinically used antimalarial natural products leads to a detailed treatment of additional natural products with significant antiplasmodial activity, classified by compound type. Although the search for new antimalarial natural products from Nature's combinatorial library is challenging, it is very likely to yield new antimalarial drugs. This book thus ends by identifying ten natural products with development potential as clinical antimalarial agents.

This book includes an international group of researchers who present the latest achievements in the field of enzyme, immune system, and microbial and nano-biosensors. It highlights the experimental evidence for formation of biological fuel cells (BFCs)-which has a dual purpose - as a device that produces electricity and the systems which produce it simultaneously cleaning up the environment from polluting organic compounds. Considering the work in the field of macro, micro and nano-biosensors, considerable attention is paid to the use of nanomaterials for the modification of working electrodes. Nanomaterials in some cases can significantly improve the parameters of analytical systems. Readers will be interested in the projection of the presented theoretical and experimental materials in the field of practical application of modern analytical developments. The presented results in many cases imply the possibility of using the created models of macro, micro and nano-biosensors, and biofuel elements in the field of health, and protection/restoration of the environment. It includes information about all existing types of transducers of signals in biosensors - electrochemical, optical and quantum-optics, thermoelectric, data of atomic force microscopy, piezoelectric, and more. On the basis of these principles, descriptions are given about the functioning of macro, micro and nano- biosensors for the detection of compounds used in medicine, detection of compounds that clog the environment, and thus affect human health, for compounds that are potentially the basis for the production of drugs, for the selection of compounds that have medicinal activity, for immunodetection, and to assess the quality of food. These questions form the basis of research carried out in the field of biosensors in the world. Since the described models of biosensors have high sensitivity, high measurement speed and selectivity, the described results attract the attention of both the ordinary reader and business class specialists who create and implement analytical technologies. This book is very useful for researchers in life sciences, chemical sciences, physics, and engineering. In addition, it will be useful for the persons working in industry. Advanced technologies specialists will be attracted by the novelty of the proposed solutions and their relevance and ease of implementation. Since the studies contain sections describing the parameters of different biosensors, BFCs, they are easily navigated into assessing the effectiveness of the practical use of the proposed device. The relevant sections indicate such characteristics as detection ranges, life span, type of biological material used, the method of formation of the bio-receptor part. These parameters are of interest to both developers of new models of biosensors and BFC, and their manufacturers.

The book presents a comprehensive and up-to-date overview of phytochemicals as efficient cancer therapeutics. Over the last few decades there has been a paradigm shift from conventional cancer therapeutic approaches to alternative and complementary medicinal approaches especially using phytoconstituents from natural products. As such, the book provides an in-depth understanding of phytochemicals targeting diverse signaling pathways involved in cancer along with the evaluation of the cancer modulatory effects of phytochemicals. It also highlights the potential modulatory effect of single nucleotide polymorphisms (SNPs) on the cancer-associated cellular pathways and their interactions with the phytochemicals. Further, it analyzes the drug delivery methods, bioavailability of active components of botanicals, and toxicity of phytochemicals. Lastly, the book elucidates the 3D cell culture and animal models systems to analyze the beneficial effects of phytochemicals in cancer.

This book targets new advances in areas of treatment and drug delivery sciences for Malaria. This is the only published book which compiles the complete road map of malarial drug delivery systems along with an overview on the pathology, current state of malaria across the globe, new clinical trials, emerging drugs and evolving novel drug delivery platforms. A wide variety of novel micro-and nano-formulations using promising technologies are being explored to deliver the malarial drug via different administration routes. This book addresses the gap between new approaches and old treatment modalities and how the former is superior in pharmacological performance when tested in in-vitro and in-vivo. Audience from wide range group like from researchers to regulatory bodies can benefit from the compiled information to find out patient needs and addresses a much-needed update to the existing malaria drug delivery research.

This book presents a multidisciplinary assessment of the state of science in the use of systemic delivery technologies to deliver anti-aging therapeutics now under development. There is a gap between basic aging research and the development of intervention technologies. This major obstacle must be overcome before biogerontological interventions can be put into clinical practice. As biogerontology comes to understand aging as a systemic degenerative process, it is clear that there is a pressing need for technologies that enable cells and tissues in a fully developed adult body to be manipulated systemically to combat aging. The authors review advances in the chemistry and engineering of systemic delivery methods and analyze the strengths and limitations of each. The book is organized into six sections. The first offers an overview of the need for systemic delivery technologies alongside the development of anti-aging therapies and describes approaches that will be required for studying the properties and efficiency of carriers for systemic delivery. Sections II, III and IV describe recent advances in a range of strategies that may enable systemic delivery to help combat aging conditions ranging from cell senescence to decline in immune function and hormonal secretion. Section V discusses practical strategies to engineer and optimize the performance of delivery technologies for applications in systemic delivery, along with their working principles. The final section discusses technical and biological barriers that must be overcome as systemic delivery technologies move from research laboratory to clinical applications aimed at tackling aging and age-associated diseases.Benefiting scholars, students and a broader audience of interested readers, the book includes helpful glossary sections in each chapter, as well as sidebars that highlight important notes, and questions for future research.