The careful choice of nanoparticles as targets and in drug delivery routes enhances therapeutic efficacy in cancer. Nanoparticle-Based Drug Delivery in Cancer Treatment discusses nanotechnological developments of interfering RNA-based nanoparticles, delivery vehicles, and validated therapeutic RNAi-molecular target interactions and explains the results of clinical and preclinical trials. The book also gives strategies for universal methods of constructing hybrid organic-inorganic nanomaterials that can be widely applied in the biomedical field. Key Features: Reviews recent advances of nanoparticle-mediated siRNA delivery systems and their application in clinical trials for cancer therapy Focuses on material platforms that establish NPs and both localized and controlled gene silencing Emphasizes the most promising systems for clinical application Surveys progress in nanoparticle-based nanomedicine in cancer treatment Describes the most advanced of the nonviral nanocarriers for delivery of oligonucleotides to malignant blood cancer cells This book is a valuable resource for researchers, professors, and students researching drug delivery, gene carriers, cancer therapy, nanotechnology, and nanomaterials.

This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental industrial and clinical perspective reflecting the many advances in techniques and methodology. The title will cover new material including the use of enzymes for the synthesis and resolution of enantiomeric compounds as well, as their use in drug discovery; how stereochemistry impacts on decisions taken during the ADMET (absorption, distribution, metabolism, excretion, toxicity) stage of drug discovery; issues faced during the final stages of the drug development process; the impact of ICH (International Conference on Harmonisation) on the use of single isomer drugs; racemic switches; and legal perspectives looking at IP and patent issues surrounding chiral switches and marketing single enantiomer switches.

This Third Edition comprehensively presents all aspects of chiral drugs from scientific, academic, governmental, industrial, and clinical points of view. This one-stop text covers the lifespan of stereochemistry, from its early history, including an overview of terms and concepts, to the current drug development process, legal and regulatory issues, and the new stereoisomeric drugs.

New topics include:

• The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery
• How stereochemistry impacts decisions made in the Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) stages of drug discovery
• A chapter on pharmacokinetics and pharmacodynamics that discusses the issues faced during the final stages of the drug development process
• The impact of International Conference on Harmonisation on the use of single isomer drugs
• Chiral switches
• The concept of molecular chiral recognition and how it affects the separation and behavior of stereochemically pure drugs
• A chapter on the legal perspectives of patent issues surrounding chiral switches and the marketing of single enantiomer switches
• This will be a one-stop shop for pharmaceutical scientists and chemists working with chiral drug molecules
  

The authoritative source on clinical data management Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text will be a timely publication in an ever-changing field. The volume:

• Is written by well-known and experienced authors in this area
• Provides new approaches to major topics in clinical data management
• Contains new chapters on systems software validation, database design and performance measures

Monoclonal antibodies have become important treatments for cancer, inflammation and a wide range of other diseases, representing an increasing share of the most successful pharmaceutical markets. The technologies to discover these drugs have been developed by select centers of excellence in industry and academia, and are continually being fine tuned in the race to identify the best antibody-based drug candidates and accelerate their paths to patients. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field and to offer specialized perspectives to established researchers. The chapters set into context the significance of key developments and important considerations for selecting different approaches, such as antibody humanization, isotype selection, lead candidate selection criteria and protein production. All contributors to this work are experts in their fields, and many have played pivotal roles in the creation of these technologies.

This detailed book collects modern and established computer-based methods aimed at addressing the drug discovery challenge from disparate perspectives by exploiting information on ligand-protein recognition. Beginning with methods that allow for the exploration of specific areas of chemical space and the designing of virtual libraries, the volume continues with sections on methods based on docking, quantitative models, and molecular dynamics simulations, which are employed for ligand discovery or development, as well as methods exploiting an ensemble of protein structures for the identification of potential protein targets. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Protein-Ligand Interactions and Drug Design provides detailed practical procedures of solid computer-aided drug design methodologies employed to rationalize and optimize protein-ligand interactions, for experienced researchers and novices alike.

Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series Topics in Medicinal Chemistry covers all relevant aspects of drug research, e.g. pathobiochemistry of diseases, identification and validation of (emerging) drug targets, structural biology, drugability of targets, drug design approaches, chemogenomics, synthetic chemistry including combinatorial methods, bioorganic chemistry, natural compounds, high-throughput screening, pharmacological in vitro and in vivo investigations, drug-receptor interactions on the molecular level, structure-activity relationships, drug absorption, distribution, metabolism, elimination, toxicology and pharmacogenomics. In general, special volumes are edited by well known guest editors

Bioactive natural products are a rich source of novel therapeutics. Thus, the search for bioactive molecules from nature continues to play an important role in fashioning new medicinal agents. This volume, which comprises sixteen chapters written by active researchers and leading experts in natural products chemistry, brings together an overview of current discoveries in this remarkable field. It also provides information on the industrial application of natural products for medicinal purposes. This book will serve as a valuable resource for researchers to predict promising leads for developing pharmaceuticals to treat various ailments and disease manifestations.

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.

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.

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.

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

Today, more than ever, the pharmacist is a full-member of the health team and many of the pharmacist's patients are using a host of other devices from various specialty areas of medicine and surgery. Medical Devices for Pharmacy and Other Healthcare Professions presents a comprehensive review of most devices that pharmacists and pharmacy personnel encounter during practice. The devices covered are relevant to pharmacists working in various work settings from hospitals, community pharmacies, and health insurance sector, to regulatory bodies, academia, and research institutes. Even if a pharmacist does not come across each of these devices on a regular basis, the book is a valuable reference source for those occasions when information is needed by a practitioner, and for instructing interns and residents. The book discusses devices needed for special pharmaceutical services and purposes such as residential care homes and primary care based with GPs, pharmacy-based smoking cessation services, pharmacy-based anticoagulant services, pain management and terminal care, medication adherence and automation in hospital pharmacy. Additional features include: Provides information on devices regarding theory, indications, and procedures concerning use, cautions, and place, in therapy. Assists pharmacists in understanding medical devices and instructing patients with the use of these devices. Focuses on providing the available evidence on effectiveness and cost-effectiveness of devices and the latest information in the particular field. Other healthcare providers interested in medical devices or involved in patients care where medical devices represent part of the provided care would benefit from the book.

This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and they have also been contributing to the progress of innovative therapies such as assisted reproductive medicine. Since the eighties, several biopharmaceuticals have been approved and, due to patents expiration, many biosimilars are also marketed. In this book, readers will find the most relevant updated information about the main clinical applications of pharmaceutical biotechnology. The authors provide expert analysis about the industrial challenges of recombinant proteins and the different classes of biopharmaceuticals, including monoclonal antibodies, vaccines, growth factors and stem cells. Topics such as bioprinting technologies in tissue engineering, gene therapy and personalized medicine are also covered in this book. Professionals, students and researchers interested in this field will find this work an important account.

With chapters from highly skilled, experienced, and renowned scientists and researchers from around the globe, Dendrimers for Drug Delivery provides an abundance of information on dendrimers and their applications in the field of drug delivery. The volume begins with an introduction to dendrimers, summarizing dendrimer applications and the striking features of dendrimers. It goes on to present the details of usual properties, structure, classification, and methods of synthesis, with relevant examples. The toxicity of dendrimers is also discussed. The chapter authors provide an exhaustive amount of information about dendrimers and their biomedical applications, including biocompatibility and toxicity aspects, a very useful feature. This informative volume will be valuable resource that will help readers to create products derived from dendrimers and navigate through the regulatory, manufacturing, and quality control hurdles. It will be an important resource for researchers, scientists, upper-level students, and industry professionals.

This collection provides detailed information on current advances in analytical methods and strategies employed for monitoring and discovering a wide range of novel psychoactive substances (NPS) in clinical and forensic laboratories. The main classes of NPS in terms of prevalence include synthetic cannabinoids, synthetic cathinones, synthetic opioids, and designer or synthetic benzodiazepines, and this book explores selecting the appropriate sample matrix and analytical testing approaches for laboratories faced with NPS drug testing, such as in blood, urine, saliva, and hair. Written for the Methods in Pharmacology and Toxicology series, chapters in this volume feature the kind of detailed implementation advice from the experts that leads to successful results in the lab. Authoritative and practical, Methods for Novel Psychoactive Substance Analysis serves as an ideal guide for forensic and clinical toxicologists, pharmacologists and chemists in academic and research settings, as well as for private laboratories seeking to increase our ability to test for these substances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:-536869121 1107305727 33554432 0 415 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:11.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; mso-bidi-font-size:11.0pt; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}

Describes 'real life' examples in Medicinal Chemistry. Integrates the use of physical, chemical, and biological concepts that are important in drug design. Highlights the "ips" and "downs" that come with drug discovery. Aims to inspire students who may be struggling with the challenges and thought process in drug design. Intends to be an excellent companion text, illustrating real life experiences, for graduate and postgraduate students.

Learn how AI and data science are upending the worlds of biology and medicine In Silico Dreams: How Artificial Intelligence and Biotechnology Will Create the Medicines of the Future delivers an illuminating and fresh perspective on the convergence of two powerful technologies: AI and biotech. Accomplished genomics expert, executive, and author Brian Hilbush offers readers a brilliant exploration of the most current work of pioneering tech giants and biotechnology startups who have already started disrupting healthcare. The book provides an in-depth understanding of the sources of innovation that are driving the shift in the pharmaceutical industry away from serendipitous therapeutic discovery and toward engineered medicines and curative therapies. In this fascinating book, you'll discover: An overview of the rise of data science methods and the paradigm shift in biology that led to the in silico revolution An outline of the fundamental breakthroughs in AI and deep learning and their applications across medicine A compelling argument for the notion that AI and biotechnology tools will rapidly accelerate the development of therapeutics A summary of innovative breakthroughs in biotechnology with a focus on gene editing and cell reprogramming technologies for therapeutic development A guide to the startup landscape in AI in medicine, revealing where investments are poised to shape the innovation base for the pharmaceutical industry Perfect for anyone with an interest in scientific topics and technology, In Silico Dreams also belongs on the bookshelves of decision-makers in a wide range of industries, including healthcare, technology, venture capital, and government.

Accounts in Drug Discovery describes recent case studies in medicinal chemistry with a particular emphasis on how the inevitable problems that arise during any project can be surmounted or overcome. The Editors cover a wide range of therapeutic areas and medicinal chemistry strategies, including lead optimization starting from high throughput screening "hits" as well as rational, structure-based design. The chapters include "follow-ons" and "next generation" compounds that aim to improve upon first generation agents. This volume surveys the range of challenges commonly faced by medicinal chemistry researchers, including the optimization of metabolism and pharmacokinetics, toxicology, pharmaceutics and pharmacology, including proof of concept in the clinic for novel biological targets. The case studies include medicinal chemistry stories on recently approved and marketed drugs, but also chronicle "near-misses", i.e., exemplary compounds that may have proceeded well into the clinic but for various reasons did not result in a successful registration. As the vast majority of projects fail prior to registration, much can be learned from such narratives. By sharing a wide range of drug discovery experiences and information across the community of medicinal chemists in both industry and academia, we believe that these accounts will provide insights into the art of medicinal chemistry as it is currently practiced and will help to serve the needs of active medicinal chemists.

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.

Consumer interest in diet and nutritional supplements is increasing dramatically. Patients and members of the public are seeking advice from health professionals, nutritionists and food scientists. This book is designed to meet the needs of those professionals who are called upon to advise patients and the general public. It provides also a valuable text for those who are researchers or decision makers in the food and pharmaceutical industries. The text presents a thorough account of this topical subject and enables the reader to appreciate the functions of nutrients in health and common disease states, to understand the current debates over the roles of nutrients and supplements in the diet, and to answer those questions frequently asked by patients and consumers.

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

Highlighting 15 selected chiral structures, which represent candidate or marketed drugs, and their chemical syntheses, the authors acquaint the reader with the fascinating achievements of synthetic and medicinal chemistry.

The book starts with an introduction treating the discovery and development of a new drug entity. Each of the 15 subsequent chapters presents one of the target structures and begins with a description of its biological profile as well as any known molecular mechanisms of action, underlining the importance of its structural and stereochemical features. This section is followed by detailed discussions of synthetic approaches to the chiral target structure, highlighting creative ideas, the scaling-up of laboratory methods and their replacement by efficient modern technologies for large-scale production. Nearly 60 synthetic reactions, most of them stereoselective, catalytic or biocatalytic, as well as chiral separating methodologies are included in the book.

Vitomir Sunjic and Michael J. Parnham provide an invaluable source of information for scientists in academia and the pharmaceutical industry who are actively engaged in the interdisciplinary development of new drugs, as well as for advanced students in chemistry and related fields.

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.

This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.

This book outlines the production of chitooligossacharides and their derivatives and discusses their main biological activities, biomedical applications and their role in disease prevention. Chitooligosaccharides are products of chitosan or chitin degradation, prepared by enzymatic or chemical hydrolysis of chitosan, and they consist mainly of N-acetyl glucosamine and glucosamine bonded with a glycosidic bond. Compared to chitin and chitosan, chitooligossacharides offer advantages for large-scale and commercial applications due to their solubility in water and lower molecular weight. Written by leading experts, this book is divided into four parts. The first part provides a general introduction to chitooligossacharides. The second part focuses on the bioproduction of chitooligossacharides through enzymatic synthesis and also covers physical and chemical methods of synthesis. The third part explores the major biological activities of chitooligosaccharides, including antioxidant, antimicrobial, anti-allergic, anti-inflammatory, anti-cancer and neuroprotective activities, and discusses the disease preventing mechanisms of chitooligosaccharides. In this section, readers will also find about the latest in vivo studies which support the use of chitooligosaccharides in the prevention and control of disease. The final part highlights important biomedical applications of chitooligosaccharides, including in tissue engineering, drug delivery and wound healing applications. It also includes the volume editor's perspective on the health and safety risks of chitooligosaccharides. Given its scope, this book is useful not only for researches in the field but also for students interested in biomaterials, pharmaceuticals, marine biotechnology, nutraceuticals and food science.