This new volume focuses on clinical biochemistry fundamentals, cell culture techniques, and drug discovery and development concepts. It deals with three different fields of clinical research: cell culture, clinical biochemistry, and drug discovery and development. The book introduces cell animal and bacterial culture techniques and their potential uses as well as cell culture techniques. The biochemistry aspect of the book covers the principles of clinical biochemistry and biochemical analysis, biochemical aids to clinical diagnosis, measurement, and quality control. The book also presents important concepts in cell membrane receptor signal transduction pathways as drug targets. The drug development focus of the book discusses the fundamentals of human disease and drug discovery. Various in silico, in vitro, and in vivo approaches for drug discovery are examined, along with a discussion on drug delivery carriers and clinical trials. Overall, the volume provides an overview of the journey from clinical fundamentals to clinical output.

This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.

Design of Hybrid Molecules for Drug Development reviews the principles, advantages, and limitations involved with designing these groundbreaking compounds. Beginning with an introduction to hybrid molecule design and background as to their need, the book goes on to explore a range of important hybrids, with hybrids containing natural products, molecules containing NO- and H2S-donors, dual-acting compounds acting as receptor ligands and enzyme inhibitors, and the design of photoresponsive drugs all discussed. Drawing on practical case studies, the hybridization of molecules for development as treatments for a number of key diseases is then outlined, including the design of hybrids for Alzheimer's, cancer, and malaria. With its cutting-edge reviews of breaking developments in this exciting field, the book offers a novel approach for all those working in the design, development, and administration of drugs for a range of debilitating disorders.

Covering all major arthropods of medical importance worldwide, this award-winning resource has established itself as a standard reference for almost 25 years. With the globilization of commerce and the world becoming more intimately connected through the everyday ease of travel, unknown arthropod species are being increasingly encountered. This means access to up-to-date, authoritative information in medical entomology has never been more important. Now in its seventh edition, this book maintains its well-acclaimed status as the ultimate easy-to-use guide to identify disease-carrying arthropods, the common signs and symptoms of vector-borne diseases, and the current recommended procedures for treatment. Includes an in-depth chapter with diagnostic aids to help physicians to recognize and accurately diagnose arthropod-related diseases and conditions more easily Updates all chapters with the latest medical and scientific findings, including Zika virus, red meat allergy, new viruses found in ticks, and vaccine development for malaria and dengue fever Presents a greater medical parasitology emphasis throughout Offers electronic downloads containing additional photographs of arthropod-caused diseases and lesions, as well as instructional videos with pest identification aids, basic entomology, and insect and pest ecology. Illustrated throughout with detailed color images to aid identification, The Goddard Guide to Arthropods of Medical Importance, Seventh Edition will remain an essential guide for physicians, public health officials, and pest control professionals.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Organic chemistry research has moved rapidly toward synthesis and medicinal application of nitrogen-containing compounds such as triazenes, triazines, and hydroxytriazenes due to their excellent biological activities. Many of them are presently in clinical trials. Triazene compounds have excellent medicinal properties and limited toxicity. Hydroxytriazenes are excellent chelating agents for transition metals. Newer studies show very promising biological and medicinal applications of these classes of compounds. Hydroxytriazenes and Triazenes: The Versatile Framework, Synthesis, and Medicinal Applications highlights synthetic methods, recent advances, and potential applications of triazines, triazenes, and hydroxytriazenes. This book includes holistic information on synthetic methods for novel compounds based on this moiety, up-to-date information on the how and why of their diverse or even multitargeted medicinal application, and future state of the art of both aspects. Other features include: Highlights recent advances and diverse possible applications of biological functions Covers the chemistry of triazine, triazene, and hydroxytriazene systems On the basis of in silico predictions, the book highlights synthetic methods and their applications A valuable source of information for those actively engaged in medicinal chemistry, drug discovery, and synthetic organic chemistry

1. Emphasis on the role of education to combat behavioral changes in AMR 2. Useful for people doing research in Microbiology, Public Health Sciences, Pharmaceutical Biology and Biotechnology 3. Discusses comparative economic analysis of AMR burden in Europe and other world regions 4. Reviews measures to preserve the pre-existing antimicrobials

Provides insight to extremophiles. Unveils the mysticism of extreme environments. Explores applications of extremophiles in biorefineries. Throws light on the advancement of industrially important extremozymes. Explores applications in biofilms and microbial corrosion.

Written by a pioneer in the development of spin labeling in biophysics, this expert book covers the fundamentals of nitroxide spin labeling through cutting-edge applications in chemistry, physics, materials science, molecular biology, and biomedicine. Nitroxides have earned their place as one of the most popular organic paramagnets due to their suitability as inhibitors of oxidative processes, as a means to polarize magnetic nuclei, and, in molecular biology, as probes and labels to understand molecular structures and dynamics AS DRAGS FOR CANCER AND OTHER DISEASES. Beginning with an overview of the basic methodology and nitroxides' 145-year history, this book equips students with necessary background and techniques to undertake original research and industry work in this growing field.

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Include advance knowledge and detailed developments in natural product science Discusses about the most important phytopharmaceuticals used in pharmaceutical industries Explores the analysis and classification of novel plant-based medicinal compounds Includes standardization, quality control, global trade of natural products Gives a deep understanding related to recent advances in the herbal medicines to treat various ailments Discusses about national and WHO regulations and policies related to herbal medicine Covers the complete profile of some important traditional medicinal plants especially their historical background, biology and chemistry

With the continued advancement of better-quality control and patient outcome reporting systems, changes in the development, control, and regulation of all pharmaceutical delivery systems including transdermal and topical products have been happening on a continuous basis. In light of various quality issues that have been reported by patients and practitioners resulting in the recall or removal of products from the market, both the pharmaceutical industries and regulatory agencies have been adopting new measures to address these issues. With chapters written by experts in this field, this book takes a 21st century multidisciplinary and cross-functional look at these dosage forms to improve the development, design, manufacturing, quality, clinical performance, safety, and regulation of these products. This book offers a wealth of up-to-date information organized in a logical sequence corresponding to various stages of research, development, and commercialization of dermal drug delivery products. The authors have been carefully selected from different sectors of pharmaceutical science for their expertise in their selected areas to present objectively a balanced view of the current state of these products development and commercialization via regulatory approval. Their insights will provide useful information to others to ensure the successful development of the next generation dermal drug products. Key Features: Presents current advancements including new technologies of transdermal and topical dosage forms. Presents challenges in the development of the new generation of transdermal and topical dosage forms. Introduces new technologies and QbD (quality by design) aspects of manufacturing and control strategies. Includes new perspectives on pre-clinical and clinical development, regulatory considerations, safety and quality. Discusses regulatory challenges, gaps, and future considerations for dermal drug delivery systems.

Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds under development. In the most comprehensive resource on the topic, this third edition of Water-Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe the detailed discussion on solubility theories, solubility prediction models, the aspects of preformulation, biopharmaceutics, pharmacokinetics, regulatory, and discovery support of water-insoluble drugs to various techniques used in developing delivery systems for water-insoluble drugs. This book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies and featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. The aim of this book is to provide a handy reference for pharmaceutical scientists in the handling of formulation issues related to water-insoluble drugs. In addition, this book may be useful to pharmacy and chemistry undergraduate students and pharmaceutical and biopharmaceutical graduate students to enhance their knowledge in the techniques of drug solubilization and dissolution enhancement.

Natural Substances for Cancer Prevention explores in detail how numerous investigations in chemical biology and molecular biology have established strong scientific evidence demonstrating how the properties of naturally occurring bioactive chemicals hamper all stages of cancers (from initiation to metastasis). Accordingly, important goals for cancer prevention are the modification of our dietary habits and an increase in the intake of more anticancer-related natural substances. More significantly, the bioactive chemicals presented in the functional foods should be readily available, inexpensive, non-toxic, and nutritional.

The advances in drug delivery systems over recent years have resulted in a large number of novel delivery systems with the potential to revolutionize the treatment and prevention of diseases. Bio-Targets and Drug Delivery Approaches is an easy-to-read book for students, researchers and pharmaceutical scientists providing a comprehensive introduction to the principles of advanced drug delivery and targeting their current applications and potential future developments.

Recent advances in high-throughput gene sequencing and other omics biotechnologies have served as a springboard for the field of pharmacogenomics. Pharmacogenomics is now generally accepted as the major determinant of variable drug safety, efficacy, and cost-effectiveness. Therefore, widespread use of pharmacogenomics for patient care has become a critical requirement. There is an unprecedented urgency for aspiring and practicing clinicians to become trained on how to interpret data from pharmacogenomic testing in preparation for the future of healthcare-i.e., personalized medicine. Applying Pharmacogenomics in Therapeutics provides timely coverage of the principles, practice, and potential of pharmacogenomics and personalized medicine. Comprised of chapters contributed by well-established pharmacologists and scientists from US and Chinese academia and industry, this authoritative text: Demonstrates how to apply the principles of pharmacogenomics and its biotechnologies in patient care Depicts the use of genetic biomarkers in drug discovery and development, laboratory medicine, and clinical services Describes the practice of pharmacogenomics in the treatment of cancers, cardiovascular diseases, neurologic and psychiatric disorders, and pulmonary diseases Discusses the merging of pharmacogenomics and alternative medicine, as well as the integration of pharmacogenomics into pharmacoeconomics Each chapter begins with the key concepts, followed by in-depth explorations of case reports or critical evaluations of genetic variants/biomarkers, and concludes with questions for self-examination.

The book Nanopharmaceuticals in regenerative medicine is a collective and comprehensive volume of the latest innovations in nanoscience technology for practical use in clinical, biomedicine and diagnostic arena. The term nanotechnology pops up in every segment of modern-day life. The primary aim of this book is to deliver the precise information to students, educators, technologists and researchers. A conglomerate of scientists from various research fields contributed to the chapters, giving detailed descriptions on the most recent developments of nanotechnology in the area of disease management. This book will also be useful for industrial research and development partners, start-up entrepreneurs, government policy makers and other professionals who are interested in nanomedicines.

With contributions from leading researchers in the nanomedicine field from industry, academia, and government and private research institutions across the globe, the volume provides an up-to-date report on topical issues in nano-drug delivery and nanotechnological approaches to tissue engineering. The volume offers research on a variety of diverse nano-based drug delivery systems along with discussions of their efficacy, safety, toxicology, and applications for different purposes. Focusing on nanotechnology approaches to tissue engineering, this volume considers the use of hydrogel systems, nanoceria and micro- and nano-structured biomaterials for bone tissue engineering, mesenchymal stem cells, and more.

This book closes a current gap by providing the scientific basis for consumer exposure assessment in the context of regulatory risk assessment. Risk is defined as the likelihood of an event occurring and the severity of its effects. The margin between the dose that leads to toxic effects and the actual dose of a chemical is identified by estimating population exposure. The objective of this book is to provide an introduction into the scientific principles of consumer exposure assessment, and to describe the methods used to estimate doses of chemicals, the statistics applied and computer tools needed. This is presented through the backgrounds of the special fields in exposure analysis, such as exposure via food and by the use of consumer products, toys, clothing and other items. As a general concept, human exposure is also understood to include exposure via the environment and from the work setting. In this context, the specific features of consumer exposure are pointed out and put into the context of regulation, in particular food safety, chemicals safety (REACh) and consumer product safety. The book is structured into three parts: The first part deals with the general concepts of consumer exposure as part of the overall risk analysis framework of risk characterization, risk assessment and risk communication. It describes the three basic features of exposure assessment (i) the exposure scenario (ii) the exposure model and (iii) the exposure parameters, addressing external and internal exposure. Also, the statistical presentation of data to characterize populations, in connection with variability, uncertainty and quality of information and the presentation of exposure evaluation results is described. The second part deals with the specific issues of exposure assessment, exposure via food consumption, exposure from use of consumer products, household products, toys, cosmetic products, textiles, pesticides and others. This part also covers methods for acquisition of data for exposure estimations, including the relevant information from regulations needed to perform an accurate exposure assessment. The third part portrays a prospect for further needs in the development and improvement of consumer exposure assessment, as well as international activities and descriptions of the work of institutions that are involved in exposure assessment on the regulatory and scientific level. And conversely, it creates the rationale for the exposure assessment details necessary to satisfy regulatory needs such as derivation of upper limits and risk management issues.

Gene delivery is a transport of genes of therapeutic values into the chromosomes of the cells or tissues which can be targeted to replace the faulty genes. In last two decades lot of research efforts are dedicated to gene delivery for therapeutic applications. Today gene therapy is promising approach in treatment of genetic diseases including mitochondrial related diseases like blindness, muscular dystrophy, cystic fibrosis, and some cancers. Gene Delivery Systems: Nano Delivery Technologies observes the exploration of nanotechnology for gene therapy and gene delivery. Written by prominent authors in the field, this book covers various aspects of gene delivery including challenges in delivering gene therapy, advances in genome editing, RNA-based gene therapy, Green nanoparticles for oligonucleotide delivery. Additional features include" Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Includes knowledge of the current application of CRISPR/Cas9 gene-editing technique; an approach that has recently been given the Noble Prize. Examines the development of mRNA vaccines for Covid -19 in challenging pandemic scenario Discusses siRNA, mRNA, and DNA plasmids.

This comprehensive book brings together experts from both the marine science and pharmacy disciplines to relay important aspects on the pharmaceutical and nutraceutical values of 175 species of bony and cartilaginous fishes as well as the uses of fish processing byproducts and wastes.Presented in an easy-to-read style, the volume provides precise identification of freshwater and marine fishes possessing pharmaceutical and nutraceutical compounds along with over 180 photographs. Aspects covered include biology, ecology, diagnostic features, and pharmaceutical and nutraceutical compounds along with their activities for each of the fish included. The book details the bioactive compounds, including fish muscle proteins, peptides, collagen and gelatin, fish oil, etc., from such species, as well as the bioactive peptides that are derived from various fish muscle proteins, which have various biological activities, including cardio protective, antihypertensive, anticancer, anti-diabetic, antibacterial, anticoagulant, anti-inflammatory, and antioxidant activities. Also discussed are the nutritional benefits of fish consumption, which are largely due to the presence of proteins, unsaturated essential fatty acids, minerals, and vitamins. The waste products obtained during fish processing are also a potential source of bioactive peptides that can be used as a source of nitrogen and amino acids, which have immunomodulatory, antibacterial, antitrombotic, and antihypertensive properties. This volume provides the information needed to tap into these vast pharmaceutical and nutraceutical benefits. Pharmaceuticals and Nutraceuticals from Fish and Fish Wastes will be of great use for students and researchers of disciplines such as pharmaceutical sciences, marine/fisheries sciences, marine microbiology, and marine biotechnology. It will also be a standard reference for libraries of colleges and universities and a guide for pharmaceutical companies involved in the development of new drugs from fishes and their wastes.

Calculations in Chemical Kinetics for Undergraduates aims to restore passion for problem solving and applied quantitative skills in undergraduate chemistry students. Avoiding complicated chemistry jargon and providing hints and step wise explanations in every calculation problem, students are able to overcome their fear of handling mathematically applied problems in physical chemistry. This solid foundation in their early studies will enable them to connect fundamental theoretical chemistry to real experimental applications as graduates. Additional Features Include: Contains quantitative problems from popular physical chemistry references. Provides step by step explanations are given in every calculation problem. Offers hints to certain problems as "points to note" to enable student comprehension. Includes solutions for all questions and exercises. This book is a great resource for undergraduate chemistry students however, the contents are rich and useful to even the graduate chemist that has passion for applied problems in physical chemistry of reaction Kinetics.

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Completely revised and updated, this third edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, biopharmaceutics, dosage form design, and drug delivery - including emerging new biotechnology-based treatment modalities. The authors integrate aspects of physical pharmacy, chemistry, biology, and biopharmaceutics into drug delivery. This book highlights the increased attention that the recent spectacular advances in gene therapy and nanotechnology have brought to dosage form design and drug delivery. With the expiration of older patents and generic competition, the biopharmaceutical industry is evolving faster than ever. Apart from revising and updating existing chapters on the basic principles, this edition highlights the emerging emphasis on drug discovery, antibodies and antibody-drug conjugates as therapeutic moieties, individualized medicine including patient stratification strategies, targeted drug delivery, and the increasing role of modeling and simulation. Although there are numerous books on pharmaceutics and dosage forms, most cover different areas of the discipline and do not provide an integrated approach. The integrated approach of this book not only provides a singular perspective of the overall field, but also supplies a unified source of information for students, instructors and professionals, saving their time and money.

The respiratory tract has been used to deliver biologically active chemicals into the human body for centuries. However, the lungs are complex in their anatomy and physiology, which poses challenges to drug delivery. Inhaled formulations are generally more sophisticated than those for oral and parenteral administration. Pulmonary drug development is therefore a highly specialized area because of its many unique issues and challenges. Rapid progress is being made and offers novel solutions to existing treatment problems. Advances in Pulmonary Drug Delivery highlights the latest developments in this field.