"Practical Utility of Biomarkers in Drug Discovery and Development" covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.

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.

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

• advances in international regulatory requirements, including ICH guidelines and harmonization
• a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
• the latest regulatory requirements for expediting new drug approvals
• strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

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.

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.

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.

To understand the drug interactions you must have a good grasp of the unit operations involved in making a tablet. This book's strategy is to begin with the fundamental physical and chemical processes that the different unit operations use and then apply this knowledge to the discussion of the different unit operations and processes.

Discovering & Developing Molecules with Optimal Drug-Like Properties provides a contemporary view on the latest research in the areathat will help readers benchmark current best practices, new research techniques and strategies, and understanding of informatics.Written with anunderlying theme of early collaboration opportunities between pharmaceutical and discovery sciences, emphasis is made ofpractical considerations, with the opportunities examined from a number of different perspectives to maximize utility to the reader. Questions like What properties of a molecule are important from a drug-like standpoint? and What are some of the new techniques and approaches that can be used to characterize and understand molecular properties relevant to molecule druggability? will be addressed in an objective scientific manner. The text covers: - in silico predictive tools - contemporary approaches to physiochemical measurements - case studies in lead optimization for drug-like properties - assessing the risk and challenges related to key physicochemical properties - design of molecules tailored for specific drug delivery approaches - the importance of phase discovery and selection on drug molecule development - use of physicochemical properties for preclinical formulation selection and early clinical formulations - new approaches to link physiochemical properties to formulation selection"

Volume 7 of the Jenny Stanford Series on Biocatalysis deals with several different aspects of pharmaceuticals, which include not only various applications of drugs and their metabolism but also natural resources for active pharmaceutical ingredients as well as the removal of pharmaceutical pollution. In detail, novel approaches for developing microbial fermentation processes to produce vitamin B6 using microorganisms are described together with novel routes for vitamin B6 biosynthesis. The other topics discussed are new approaches for producing the successful anticancer drug Taxol from naturally occurring precursors, molecular farming through plant engineering as a cost-effective means to produce therapeutic and prophylactic proteins, and successful screening of potent microorganisms producing L-asparaginase for various chemotherapeutic applications. Furthermore, microbial biotransformations in the production and degradation of fluorinated pharmaceuticals are described. The other chapters inform the reader about the biotransformation of xenobiotics/drugs in living systems, the degradation of pharmaceuticals by white-rot fungi and their ligninolytic enzymes, and the removal of pharmaceutical pollution from municipal sewage using laccase.

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.

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.

As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

Dendrimers, hyperbranched macromolecules, emerged just few decades ago but show promising potential as drug delivery nanocarriers, theranostic agents and gene vectors; in the pharmaceutical research and innovation area as well as in other healthcare applications. Although tremendous advancements have been made in dendrimer chemistry and their applications since their emergence, the synthesis, development and design of pure and safe dendrimer-based products have been a major challenge in this area. This book, edited by well-known researchers in the area of nanomaterials and drug-based drug delivery applications, exhaustively covers the nanotechnological aspects, concepts, properties, characterisation, application, biofate and regulatory aspects of dendrimers. It includes sixteen vivid chapters by renowned formulators, researchers and academicians from all over the world, highlighting their specialised areas of interest in the fields of chemistry, biology, pharmacy and nanomedicine. Features: * Highlights dendrimers' advancements in nanomedicine in the development of safe healthcare and biotechnological products * Covers physicochemical aspects, biofate, drug delivery aspects and gene therapy using dendrimers * Covers biomedical application of dendrimers in the field of biological sciences * Gives examples of dendrimer-guest interaction chemistry Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives provides the comprehensive overview of the latest research efforts in designing, optimising, development and scale-up of dendrimer-mediated delivery systems. It analyses the key challenges of synthesis, design, molecular modelling, fundamental concepts, drug delivery aspects, analytical tools and biological fate as well as regulatory consideration to the practical use of dendrimer application. Dr. Neelesh Kumar Mehra Assistant Professor of Pharmaceutics in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He has authored more than sixty peer-reviewed publications in highly reputed international journals, as well as book chapters and contributions on two patents. Dr. Mehra has 11 years of rich research and teaching experience in the formulation and development of complex, innovative biopharmaceutical products including micro- and nanotechnologies for regulated markets. Dr. Keerti Jain Assistant Professor of Pharmaceutics in the Department of Pharmaceutics, NIPER, Raebareli, India. For more than 10 years, she has been actively engaged in formulation and development of nanomedicines. Dr. Jain has supervised masters and doctoral pharmaceutics students in their research works which have been published in high quality, good impact factor journals. She has also authored more than 60 international manuscripts in peer reviewed high impact journals. In 2019, she was awarded the prestigious ICMR-Amir Shakuntala Award.

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.

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.

The recent introduction of nanomedicines in the drug therapy arena is revolutionizing the management of severe diseases. The key advance in the field is the optimization of the biological fate of drug molecules, thus improving the therapeutic effect while keeping to a very minimum the associated toxicity. Volume one of this book series, Nanoplatforms in Drug Delivery, established the basic aspects in the development of drug-loaded nanoplatforms, the so-called nanomedicines or nanodrugs, focusing on representative materials and strategies used in their formulation. Taking advantage of the advanced conceptualizations on nanomedicine engineering that were described in volume one, volume two, Nano-Engineering Strategies and Nanomedicines against Severe Diseases, analyzes in depth special features related to the formulation of nanoplatforms for oral, dental, topical and transdermal, pulmonary and nasal, ocular and otic, vaginal, and brain drug delivery and targeting. Particular aspects of nanomedicine engineering and in vivo fate associated with the routing of drug administration are given special attention. In addition, an up-to-date view is presented on the use of nanomedicines against severe diseases, such as cancer, cardiovascular diseases, neurodegenerative disorders, infectious diseases, chronic inflammatory diseases, and metabolic diseases. The chapters analyze the key factors that need to be controlled to achieve the optimum therapeutic effect. Attention is further given to gene delivery and the recent concept of nanotheranosis.

Computational methods impact all aspects of modern drug discovery and most notably these methods move rapidly from academic exercises to becoming drugs in clinical trials.

This insightful book represents the experience and understanding of the global experts in the field and spotlights both the structural and medicinal chemistry aspects of drug design. The need to 'encode' the factors that determine adsorption, distribution, metabolism, excretion and toxicology are explored, as they remain the critical issues in this area of research. This indispensable resource provides the reader with:
A rich understanding of modern approaches to docking;
A comparison and critical evaluation of state-of-the-art methods;
Details on harnessing computational methods for both analysis and prediction;
An insight into prediction potencies and protocols for unbiased evaluations of docking and scoring algorithms;
Critical reviews of current fragment based methods with perceptive applications to kinases.

Addressing a wide range of uses of protein structures for drug discovery the Editors have created an essential reference for professionals in the pharmaceutical industry and moreover an indispensable core text for all graduate level courses covering molecular interactions and drug discovery.

The first edition of this work was written by W.A. Poucher in 1923. His aim was to produce a comprehensive coverage of products giving simple background theories with basic formulations and their methods of manufacture. This new edition follows in this tradition and maintains the simplicity of approach aimed at students or specialists in one discipline, with some knowledge of science, who need an introduction to cosmetic science and technology. In the 17 years since the publication of the last edition, cosmetic science has developed to such an extent that men and women working in research and the industry, specialize in different disciplines and selected product categories, therefore each chapter has been written by specialist authors. Part 1 deals with products in alphabetical order, following previous editions. In the respective chapters, an outline of the biology and function of the skin and its appendages, ie hair, teeth and nails, is given, followed by descriptions of the needs for products, their formulation and manufacture. In Part 2 there are seven chapters covering the knowledge required and the procedures to follow when marketing cosmetics. They are analytical methods, efficacy testing, emulsion theory, microbial control, legislation, safety and stability. Part 3 contains three chapters covering historical background, the perfuming of products and lastly the psychology of fragrance. This book provides a basic knowledge of "cosmetics" - a word which covers any product used to cleanse, protect or adorn the human body. It aims to serve as a valuable introduction and source of reference for all those involved in the cosmetics and toiletries industry, including suppliers of raw materials, manufacturers of finished products, R&D laboratories in industry and educational institutions as well as beauty clinics and schools.

One of the most promising new approaches for the prevention of HIV transmission, particularly for developing countries, involves topical, self-administered products known as microbicides. The development of microbicides is a long and complicated process, and this volume provides an overview of all the critical areas, from the selection of appropriate candidate molecules and their formulation, preclinical and clinical testing for safety and efficacy, strategies for product registration and finally, issues associated with product launch, distribution and access. The book will prove valuable to both those working in the field and all others who are interested in learning more about this product class, which has the potential to significantly impact the future of this devastating epidemic.

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

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 metal-based and other nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. It discusses silver, hybrid gold, and surface-modified magnetic nanoparticles, fluorescent quantum dots, lipid bubbles, and nanobubbles. It provides all available information about these materials and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully. The text also covers topics such as improving bioactivity of poorly soluble actives, cellular and molecular toxicology of nanoparticles, and biofate of nanoemulsions.

Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research. Interpreting lessons learned from the clinical trials of first generation drugs, the book evaluates the technology as a whole and offers new directions and avenues of research and development.

Divided into five parts, the book begins with a thorough introduction to the mechanism of antisense drug action including the RNase H mechanism, small RNA silencing pathways, and the potential therapeutics of splice switching oligonucleotides. Leading researchers demonstrate the basics of oligonucleotide therapeutics in part two by delineating medicinal chemistry, pharmacokinetics, and delivery routes such as liposomal formulations for nucleic acid delivery. Part three details hybridization based drugs and considers the dramatic advances represented by 2' methoxyethyl chimeric antisense inhibitors and duplex RNA drugs. Other chemical classes of drugs and mechanisms of action are described in part four with further discussions on improving the second generation antisense drugs. The final part delves deeply into therapeutic applications. Contributing authors examine the potential of antisense drugs for the alleviation of cardiovascular diseases, metabolic diseases, inflammatory diseases, cancer, neurological disorders, and immune modulation.

Presenting a highly detailed, lucid discussion of the remarkable advances in the field, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition provides theplatform for researchers to continue to aggressively pursue the great opportunity represented by this exciting technology.

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.