Globally, natural medicine has been considered as an important alternative to modern allopathic medicine. Although natural medicines are popular in society, only limited medicinal herbs have been scientifically evaluated for their potential in medical treatment. This book connects various aspects of the complex journey from traditional medicine to modern medicine. It provides information on topics including global regulations and regulatory hurdles, diverse nutritional challenges and potential health benefits, novel food innovations especially seed-to-clinic approaches, and future trends. FEATURES * Provides information on sustainable use of natural products in the development of new drugs and clinically validated herbal remedies * Discusses issues on evaluation and clinical aspects of herbal medicine, promotion and development, safety evaluation, metabolite profiling, biomarker analysis, formulation, and stability testing * Describes traditional uses of natural medicine through identification, isolation and structural characterization of their active components * Elucidates mechanisms of biological action, adverse effects and identification of their molecular targets of natural medicine * Multidisciplinary appeal including chemistry, pharmacology, pharmacognosy and cell and molecular biology, as well as integration with clinical medicine This book serves as an essential guide for individuals researching natural medicines, and industry employees in areas including drug development, pharmacology, natural products chemistry, clinical efficacy, ethnopharmacology, pharmacognosy, phytotherapy, phyto-technology and herbal science.

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

Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

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

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration, process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource. Key Features: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

With potentially high specificity and low toxicity, biologicals offer promising alternatives to small-molecule drugs. Peptide therapeutics have again become the focus of innovative drug development efforts backed up by a resurgence of venture funds and small biotechnology companies. What does it take to develop a peptide-based medicine? What are the key challenges and how are they overcome? What are emerging therapeutics for peptide modalities? This book answers these questions with a holistic story from molecules to medicine, combining the themes of design, synthesis and clinical applications of peptide-based therapeutics and biomarkers. Chapters are written and edited by leaders in the field from industry and academia and they cover the pharmacokinetics of peptide therapeutics, attributes necessary for commercially successful metabolic peptides, medicinal chemistry strategies for the design of peptidase-resistant peptide analogues, disease classes for which peptide therapeutic are most relevant, and regulatory issues and guidelines. The critical themes covered provide essential background information on what it takes to develop peptide-based medicine from a chemistry perspective and views on the future of peptide drugs. This book will be a valuable resource not only as a reference book for the researcher engaged in academic and pharmaceutical setting, from basic research to manufacturing and from organic chemistry to biotechnology, but also a valuable resource to graduate students to understand discovery and development process for peptide-based medicine.

This volume, the first of the two-volume Drug Delivery Approaches and Nanosystems series, presents a full picture of the state-of-the-art research and development in drug delivery systems using nanotechnology and its applications. It addresses the ever-expanding application of nanotechnology or nano-sized materials in the medical field and the real-world challenges and complexities of current drug delivery methodologies and techniques. Many methods of drug delivery systems have been used, but very few of them have been validated for medical use. A major reason for the above situation, the editors believe, is the gap between academia and research, and the gap between academic research and real-time clinical applications and needs. This volume addresses that gap. This volume presents 12 chapters that provide information about the preparation and characterization of nanocomposite materials used in drug delivery systems; advanced research of carbon nanotubes, nanocomposite materials, and polymer-clay, ceramics, and silicate glass-based nanocomposites; and the functionality of graphene nanocomposites. The book also provides detailed information on the application of nanotechnology in drug delivery systems in health care systems and medicine. The book describes how nanostructures are synthesized and draws attention to wide variety of nanostructures available for biological research and treatment applications. This valuable volume provides a wealth of information that will be valuable to scientists and researchers, faculty, and students. Volume 2 of the two-volume series is subtitled Drug Targeting Aspects of Nanotechnology. The volumes are available separately or as a set.

This volume is a thorough presentation of the state-of-the-art research and developments in drug delivery systems using nanotechnology and its applications. The second of this two-volume set, it addresses the applications of nanotechnology or nano-sized materials in the medical field and the real-world challenges and complexities of current drug delivery methodologies and techniques. This volume includes 11 chapters that focus on the targeting facet of drug delivery systems. Targeting is a focused maneuver to achieve the specified goals, including achieving the desired result and reaching the specific location. Targeting has now been successfully achieved for several diseases/disorders; however, its role is noteworthy in cancer treatment where chemotherapy is a main course of approach. Nanotechnology-based products have great potential by virtue of their inherent features. This edited book provides a detailed application of nanotechnology in drug delivery systems in health care. The book discusses general principles of drug targeting, material of construction and technological concerns of nanoparticles, and different drug delivery systems and their preparation. Taken together, the informative chapters will provide researchers and scientists as well as faculty and students with valuable research on the effective use of new approaches in advanced drug delivery nanosystems. Volume 1 of the two-volume series is subtitled Novel Drug Carriers. The volumes are available separately or as a set.

The deregulation of dietary supplements and natural products marketing by the FDA has widened the natural products market in Europe and worldwide. While the discussion about the validity of the plant approach to nutrition and diseases treatment continues, the explosion of the use of whatever is considered "natural" has generated concern about effectiveness and danger. Incorporating information ranging from regulatory aspects to clinical trial and vigilance, Herbal Medicines: Development and Validation of Plant-Derived Medicines for Human Health: Provides a reference model for those who would like to start the R&D process for a natural product Discusses fundamental issues in the development of traditional medicines for the benefit of human health Takes a sequential rational approach to the subject matter Brings awareness to the many problems facing the development of medicinal herbal products, such as quality control, pharmacokinetic, and pharmacodynamic issues This book takes readers on a rational path for development of efficacious medicinal herbal products. It points out the many problems facing the development of these products, such as quality control, pharmacokinetic, and pharmacodynamic issues. It suggests areas where future developments should occur given healthcare needs and public health considerations.

The approach to drug discovery from natural sources has yielded many important new pharmaceuticals inaccessible by other routes. In many cases the isolated natural product may not be an effective drug for any of several reasons, but it nevertheless may become a drug through chemical modification or have a novel pharmacophore for future drug design. In summarizing the status of natural products as cancer chemotherapeutics, Anticancer Agents from Natural Products, Second Edition covers the: History of each covered drug-a discussion of its mechanism on action, medicinal chemistry, synthesis, and clinical applications Potential for novel drug discovery through the use of genome mining as well as future developments in anticancer drug discovery Important biosynthetic approaches to "unnatural" natural products Anticancer Agents from Natural Products, Second Edition discusses how complex target-oriented synthesis-enabled by historic advances in methodology-has enormously expanded the scope of the possible. This book covers the current clinically used anticancer agents that are either natural products or are clearly derived from natural product leads. It also reviews drug candidates currently in clinical development since many of these will be clinically used drugs in the future. Examples include the drugs etoposide and teniposide derived from the lead compound podophyllotoxin; numerous analogs derived from taxol; topotecan, derived from camptothecin; and the synthetic clinical candidates, E7389 and HTI-286, developed from the marine leads, halichondrin B and hemiasterlin.

Focusing on nanoparticulate nanocarriers and recent advances in the field of drug delivery, the volume begins with chapters that provide an informative introduction to polymeric nanoparticles-their general physicochemical features and characteristics, their applications in drug delivery systems, and the challenges involved. Specific applications are discussed, with attention paid to treatment of particular diseases and disorders and the targeting of specific organs. Part 2 looks at more specific applications and techniques of nanoparticulate nanocarriers for drug delivery, such as the use of magnetic nanoparticles, gold nanoparticles in therapeutics, and superparamagnetic iron oxide nanoparticles (SPIONs) for the treatment of cancer. Part 3 discusses lipid-based nanoparticulates for various applications, including skin care. The last section of the book explores some of the newer nanoarchitectures, including dendrimers in gene delivery and carbon nanotubes for drug delivery. Together, the insightful research presented here provides valuable information for those involved in this area, including scientists and researchers and faculty and upper-level students, as well as for industry professionals.

This important new book provides the fundamental understanding of the peptide and protein drug delivery systems with a special focus on their nanotechnology applications. Addressing an increasing interest in peptide and protein drug delivery systems in both academic and industrial circles worldwide, this book fills the need for a comprehensive review and assessment of conventional and nonconventional routes of administration.

This new volume focuses on the ever-growing and ever-sophisticated use of nanobiomaterials in drug delivery. There have been significant developments in the delivery of the active pharmaceutical ingredients to target sites, thereby sparing the normal functioning biological systems from damage, and this volume highlights some of the most important developments in the field. The book first provides an overview of nanobiomaterials and then goes on to report on new developments in drug delivery and nanotechnology, nanobiomaterials as carriers in cancer therapy, and the diverse uses of nanobiomaterials. Broken into sections, the chapters cover: an overview of nanobiomaterials drug delivery and nanotechnology nanobiomaterials as carriers in cancer therapeutics diverse uses of nanobiomaterials This volume will be a valuable resource on drug delivery for pharmaceutical manufacturers, healthcare personnel, and researchers.

A consolidated and comprehensive reference on ligand-binding assays

Ligand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. "Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena" answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field.

"Ligand-Binding Assays" covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include:

A general discussion of challenges and proven approaches in the development of ligand-binding assays

More detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline

A concise, but detailed, discussion of validation of ligand-binding assays for macromolecules

A practical approach to "fit-for-purpose" validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies

Written by a team of world-recognized authorities in the field, "Ligand-Binding Assays" provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.

Dendrimers are a new class of macromolecule increasingly used in the fields of synthetic organic chemistry, biology, medicine and biotechnology. Dendrimers in Medicine and Biotechnology: New Molecular Tools looks at this exciting and rapidly growing area of science. Using an interdisciplinary approach with particular emphasis on biological applications, the book discusses the relationship between the dendrimer molecular motif and its biological properties. A general introduction to the subject of dendrimers, including definitions of terms and symbols, is provided. Subsequent sections discuss topics including dendrimers in biological systems, dendrimers as drug delivery devices, dendrimers in diagnostics and dendrimer drugs. Throughout the book examples from current research are also provided. This book will appeal to a wide range of scientists, including non specialists who require an introduction to dendrimers, as well as those wishing to know more about the application of dendrimers in the field of biology and medicine.

Hydrogels are crosslinked, macromolecular polymeric materials arranged in a three-dimensional network, which can absorb and retain large amounts of water. Hydrogels are commonly used in clinical practice and experimental medicine for a wide range of applications, including drug delivery, tissue engineering and regenerative medicine, diagnostics, cellular immobilization, separation of biomolecules or cells, and barrier materials to regulate biological adhesions. This book elucidates the underlying concepts and emerging applications of hydrogels and will provide key case studies and critical analysis of the existing research.

This book covers the broad field of cellular, molecular, preclinical, and clinical imaging either associated with or combined with photodynamic therapy (PDT). It showcases how this approach is used clinically for cancer, infections, and diseases characterized by unwanted tissue such as atherosclerosis or blindness. Because the photosensitizers are also fluorescent, the book also addresses various imaging systems such as confocal microscopy and small animal imaging systems, and highlights how they have been used to follow and optimize treatment, and to answer important mechanistic questions. Chapters also discuss how imaging has made important contributions to clinical outcomes in skin, bladder, and brain cancers, as well as in the development of theranostic agents for detection and treatment of disease. This book provides a resource for physicians and research scientists in cell biology, microscopy, optics, molecular imaging, oncology, and drug discovery.

This new book, from the editor of the highly successful Pharmaceutical Analysis, sets out to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. It focuses less on prototypes of drugs that perhaps never came to market and more on the drugs currently in use. The emphasis in the book is on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target. Important physicochemical properties include pKa and partition coefficient and the properties of the structural elements within the drug which provide interactions with the target via a range of intermolecular forces. The last fifteen years has seen a great advance in the knowledge of protein structures and a strong emphasis is given to the interaction of drugs with proteins which shape the majority of drug mechanisms. Features: Focus on intramolecular actions Mechanisms of action richly illustrated Self-assessment included Comprehensive chapters on vitamins and biotechnological products Focus on intramolecular actions Mechanisms of action richly illustrated Self-assessment included Comprehensive chapters on vitamins and biotechnological products

Ethnobotany: Local Knowledge and Traditions discusses various plants that have actually been used in traditional medicine for a specific ailment. It desribes the biological effectiveness (activities) related to each "sickness" which have been scientifically verified. This book will also discuss the bioactivities established/determined that are promising and have potential. Finally, this book will be an appropriate consultation tool for scientists/professionals/experts such as ethnobotanists, botanists, cell/molecular biologists, chemists, pharmacists, pharmacologists, environmentalists/ecologists.

While silk derived from silkworm has been of economic importance for centuries, more recently silkworm has been found to have utility in biomedicine. This has attracted attention for expressing eukaryotic recombinant proteins, which require post-translational modifications. In 1985 Dr. Susumu Maeda demonstrated that silkworm larvae could produce a functional human-interferon. Since then various techniques have been developed to express recombinant proteins in silkworm. With the development of the Bombyx mori nucleopolyhedrovirus (BmNPV) bacmid system, which is capable of replicating in both Escherichia coli and Bombyx mori derived cell lines or silkworm, silkworm larvae or pupae have been used for the expression system for recombinant protein production. This method has the advantage of a bacmid, in that it can be easily prepared for sufficient bacmid DNA for subsequent expression in silkworm. It is potentially a big breakthrough in production of recombinant eukaryotic proteins and viruses, which will be a powerful tool in a new proteome era. This volume contributes to the advancement of our knowledge in the subject, for example gene expression systems and silkworm research, and focuses on silkworm biofactories for the recombinant protein production and commercial applications of proteins.

The pharmaceutical industry recognizes the shift to the use of natural products while also considering the serious concerns that have arisen regarding the claimed efficacy, quality, and safety of these products. This volume showcases how pharmaceutical and nutraceutical compounds from natural products can be used to cure or prevent diseases. The chapters explore the connections between agrochemicals and pharmaceuticals and the use of plants and plant products in the formulation and development of new pharmaceuticals and nutraceuticals.

Structure-based drug discovery is a collection of methods that exploits the ability to determine and analyse the three dimensional structure of biological molecules. These methods have been adopted and enhanced to improve the speed and quality of discovery of new drug candidates. After an introductory overview of the principles and application of structure-based methods in drug discovery, this book then describes the essential features of the various methods. Chapters on X-ray crystallography, NMR spectroscopy, and computational chemistry and molecular modelling describe how these particular techniques have been enhanced to support rational drug discovery, with discussions on developments such as high throughput structure determination, probing protein-ligand interactions by NMR spectroscopy, virtual screening and fragment-based drug discovery. The concluding chapters complement the overview of methods by presenting case histories to demonstrate the major impact that structure-based methods have had on discovering drug molecules. Written by international experts from industry and academia, this comprehensive introduction to the methods and practice of structure-based drug discovery not only illustrates leading-edge science but also provides the scientific background for the non-expert reader. The book provides a balanced appraisal of what structure-based methods can and cannot contribute to drug discovery. It will appeal to industrial and academic researchers in pharmaceutical sciences, medicinal chemistry and chemical biology, as well as providing an insight into the field for recent graduates in the biomolecular sciences.

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models; discusses problems related to frailty models, such as tests for homogeneity; and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using the statistical packages of R, SAS, and Stata. The appendix provides the technical mathematical results used throughout. Written in nontechnical terms accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real-world data application and interpretation of the results. By applying several models to the same data, it allows for the comparison of their advantages and limitations under varying model assumptions. The book also employs simulations to analyze the finite sample size performance of the models.