The book provides valuable information on wild plants and their ethnopharmacological properties, discussion on ethnobotany, phytotherapy, diversity, chemical and pharmacological properties including antifungal, anti-inflammatory and antiprotozal properties. The chapters include a wide range of case studies, giving updated evidence on importance of wild plant resources from different countries including Nepal, India, Brazil, Chile, Argentina, Colombia, Egypt, Peru, etc. In addition, some specific species are used to explain their potential properties. Discussing traditional usage and pharmacological properties of wild plants, this book is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policy making, etc.

Metals in pharmaceuticals have played an increasingly important role in medicine over the last century, particularly in cancer therapy and diagnostic imaging methods. Medicinal Applications of Coordination Chemistry focuses on the role that transition metals play in clinical applications. Medicinal Applications of Coordination Chemistry begins with a brief historical review and an introduction to the chemistry of d- and f- block metals. Subsequent sections discuss metallodrugs for a number of different applications, the design of new drugs and the relationship between structure and function. Key sections include diagnostic applications of metal compounds in anatomical and functional imaging, and therapeutic applications of metals compounds. This book is ideal for researchers in academia and industry and comes complete with examples of real life applications.

Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies. Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference: Describes statistical models used to characterize dose-response patterns of monotherapies and evaluate the combination drug synergy Offers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interaction Introduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate use Examines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviews Evaluates computational tools and software packages used to apply novel statistical methods in combination drug development Statistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.

The first edition of Pharmaceutical Extrusion Technology, published in 2003, was deemed the seminal book on pharmaceutical extrusion. Now it is expanded and improved, just like the usage of extrusion has expanded, improved and evolved into an accepted manufacturing technology to continuously mix active pharmaceutical ingredients with excipients for a myriad of traditional and novel dosage forms. Pharmaceutical Extrusion Technology, Second Edition reflects how this has spawned numerous research activities, in addition to hardware and process advancements. It offers new authors, expanded chapters and contains all the extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms. Key Features: Reviews how extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients Focuses on equipment and process technology Explains various extrusion system configurations as a manufacturing methodology for a variety of dosage forms Presents new opportunities available only via extrusion and future trends Includes contributions of experts from the process and equipment fields

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies-experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections-causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, industry, and health organizations address various aspects of the important problems in global clinical development and MRCTs. The book first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics from MRCT perspectives, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices. Explaining how to design, conduct, and interpret MRCTs, this book will help biostatisticians working in the late-stage clinical development of medical products. It will also be useful for statisticians and clinicians in the biopharmaceutical industry, regulatory agencies, and medical research institutes.

Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials. The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving. This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.

Since the first TRP ion channel was discovered in Drosophila melanogaster in 1989, the progress made in this area of signaling research has yielded findings that offer the potential to dramatically impact human health and wellness. Involved in gateway activity for all five of our senses, TRP channels have been shown to respond to a wide range of stimuli from both within and outside the cell body. How we sense heat and cold, how we taste food, how eggs are fertilized, how the heart expands and contracts is each dependent on the function of these channels. While no single book could possibly cover all the research being undertaken, TRP Ion Channel Function in Sensory Transduction and Cellular Signaling Cascades presents the most advanced compilation of work in this area to date. All 31 chapters are written by international pioneers working at the vanguard of TRP ion channel research. They explain much about the pivotal function and behavior of these channels, which are most exquisitely tuned to their specific tasks, and delve into how researchers are putting this knowledge to use in the development of novel pharmaceuticals, which may well prove effective in ameliorating treatment-resistant conditions including cancer, heart disease, inflammation, and immune system dysfunctions. Individual chapters shed light on selected topics of interest in the TRP arena, such as signal transduction in axonal path-finding, and in vascular, renal, and auditory functions, as well as pain. The text also covers subjects as diverse as mating and fertilization, inflammatory pain, and mechanisms of pheromone detection in mammals. While the book presents much new insight and explores findings that will be ofinterest to those involved with advanced research, it also includes significant background material for those looking to familiarize themselves with this exceptionally promising path of inquiry.

Liposome Technology, Volume I: Liposome Preparation and Related Techniques, Third Edition, is a thoroughly updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume I illustrates numerous methods for liposome preparation and auxiliary techniques necessary for the stabilization and characterization of liposomes. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.

In order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structure and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market. This title is a comprehensive guide for recognizing the chemical underpinnings of drug metabolism. While there are numerous resources available to medicinal chemists for understanding drug structure, and to pharmacologists for discerning drug metabolism from a biological standpoint, no resource currently exists that links the chemical and biological aspects in language accessible to both-making it challenging for both groups to fully comprehend how a drug is metabolized, as well as the potential effects of the metabolites. Drug Metabolism: Chemical and Enzymatic Aspects provides extensive material to help understand drug metabolism within a biological context, and for predicting and mitigating adverse drug reactions.

Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine. Written mainly by industry experts, the book includes information sourced directly from the company that developed or manufactured the product. It explores major development issues, from manufacturing and marketing to delivery of the finished product. Chapter 1 reviews applied enzymology while chapter 2 delineates theory and applications. Between them, the first two chapters set the appropriate backdrop for the remaining chapters, which focus on actual enzyme products that have gained regulatory approval for general medical use. The chapter authors discuss the biochemistry of the enzymes, the reactions they catalyze, how they are produced or manufactured, and their medical applications. The book highlights the many applications of approved therapeutic enzymes, including use in the treatment of blood-clotting disorders, certain cancers, and a variety of genetic disorders. Illustrated with tables and figures that support the text, the book is a single source of in-depth technical information.

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity. The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods. A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.

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.

This book on hollow fiber contractors presents an up-to-date compilation of the latest developments and milestones in this membrane technology. Hollow Fiber Membrane Contactors: Module Fabrication, Design and Operation, and Potential Applications provides a comprehensive discussion of hollow fiber membrane applications (including a few case studies) in biotechnology, chemical, food, and nuclear engineering. The chapters in this book have been classified using the following, based on different ways of contacting fluids with each other: Gas-liquid contacting; Liquid-liquid contacting; Supported liquid membrane; Supported gas membrane; Fluid-fluid contacting. Other features include: Discusses using non-dispersive solvent extraction, hollow fiber strip dispersion, hollow fiber supported liquid membranes and role of process intensification in integrated use of these processes Provides technical and economic perspectives with several case studies related to specific scenarios Demonstrates module fabrication, design, operation and maintenance of hollow fiber contactors for different applications and performance Presents discussion on newer concepts like membrane emulsification, membrane nanoprecipitation, membrane crystallization and membrane condenser Special focus on emerging areas such as the use of hollow fiber contactor in back end of nuclear fuel cycle, membrane distillation, dehumidification of air and gas absorption and stripping Discusses theoretical analysis including computational modeling of different hollow fiber membrane processes, and presents emphasis on newly developed area of hollow fiber membrane based analytical techniques Presents discussion on upcoming area dealing with hollow fiber contactors-based technology in fermentation and enzymatic transformation and in chiral separations This book is equally suited for newcomers to the field, as well as for engineers and scientists that have basic knowledge in this field but are interested in obtaining more information about specific future applications.

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.

The proliferation of herbal remedies worldwide has most dangerously outpaced quality information on their safe use. This book fills a tremendous void by offering authoritative information on the actions of herbal remedies and the results of their interactions with standard medications. It offers specific, authoritative information with a conceptual approach that focuses not only on the specific interactions, but also on the mechanisms behind those interactions and their clinical significance. With contributions from leading experts on herb-drug interactions, the text examines the overall use of herbs, includes sections on individual herbs, and considers regulatory issues and concerns.

In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of polymeric nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. Beginning with the combinatorial approach for polymer design, it discusses star-shaped amphiphilic polymers, self-assembling polymer-drug conjugates, amphiphilic dendrimers, dendrimer nanohybrids, sustainable green polymeric nanoconstructs, chitosan-based nanogels, and multifunctional hybrid nanogels. The book provides all available information about these materials and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully.

Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may facilitate more advanced technologies in the field.

This book provides a broad range of applications and recent advances in the search for biofilm materials in nature. It also explains the future implications for biofilms in the areas of advanced molecular genetics, pharmaceuticals, pharmacology, and toxicology. This book is comprised of 20 chapters from leading experts in the field and it examines immunology and microbiological studies derived from biofilms as well as explores environmental, agricultural, and chemical impacts on biofilms. It is divided into five subdivisions: biofilms and its complications, biofilm infections in human body, detection of biofilm-forming pathogens, antibiofilm chemotherapy, and biofilms production tools in aquaculture. This book may be used as a text or reference for everyone interested in microbial biofilms and their current applications. It is also highly recommended for environmental microbiologists, medical microbiologists, bioremediation experts, and microbiologists working in biocorrosion, biofouling, biodegradation, water microbiology, quorum sensing, and many other related areas. Scientists in academia, research laboratories, and industry will also find it of interest. This book includes chapter homework problems and case studies. Powerpoints are also available for adopting instructors. Discusses and clarifies the resource of isolation and chemical properties from biofilms Discusses the latest pharmaceutical, pharmacological, and medicinal approaches toward the treatment of chronic and uncured diseases, such as Alzheimer's osteoporotic, sexual dysfunction, sleep sickness, allergy treatment, asthma, hair loss, AIDS, hypertension, antiaging, etc. Examines immunology and microbiological studies derived from biofilms Explores environmental, agricultural, and chemical impacts on biofilms. Dr. Bakrudeen Ali Ahmed Abdul is an Associate Professor, the Head of the Department of Biochemistry and Dean of the School of Life Sciences, Centre for Research and Development (CRD), PRIST Deemed University, Vallam, Thanjavur, Tamil Nadu, India. His research areas include the application of plant biochemistry, bioactive compound production, biotechnological methods, development of pharmaceutical products and pharmacological studies.

This book offers a broad summary of the wild plants and their usage, as well as the growing interest in ethnopharmacology research. The book comprises of important issues such as diversity of wild plants with emphasis on medicinal and food plants, threats to wild plants and traditional ethnobotanical knowledge, their uses in skin diseases, snake-bites, in cosmeceuticals, etc. Moreover, the ethnopharmacological relevance of wild plants in Latin America has been discussed. The chapters include a wide range of case studies, giving updated evidence on the importance of their wild plant resources from different countries including Peru, Nepal, Bangladesh, India, Pakistan, Brazil. In addition, some specific species are used to explain their potential properties, as well as the dangers of their use without guidance of trained natural healers. The book discusses traditional usage and properties of wild plants and is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policymakers, etc.

Divided into three expansive sections on biotechnological advances, applications, and research prospects, this reference provides expert summaries of the state-of-the-science in personal care product development-clearly depicting the latest breakthroughs and practices in biotechnology for the formulation and increased safety of new personal care ingredients.