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Drug Metabolism and Pharmacokinetics: Frontiers, Strategies, and Applications
by Liang Shen WuXi AppTec DmpkPractical, state-of-the-art pharmacokinetic research methods, ideas, advancements, applications, and strategies Drawing on a wealth of extensive practical experience and theoretical research, Drug Metabolism and Pharmacokinetics encapsulates the most recent advancements and illustrative applications in the field. Sixty-eight relatively independent yet interconnected articles are included, each offering a unique perspective and providing in-depth interpretation. Readers can either read systematically or select specific topics of interest from the table of contents. Basic concepts, frontier advancements, DMPK research strategies, and technical methods are covered for novel drug modalities and therapeutics in different disease areas. The book encompasses a wide range of application and validation cases for DMPK research, including studies in in vitro ADME, in vivo pharmacokinetics, metabolite profiling and identification, radiolabeled ADME, and bioanalysis. Case studies showing the application of topics covered are included throughout, along with valuable insights into problem-solving and critical thinking. Written by a team of scientists specializing in DMPK research from the DMPK Department of WuXi AppTec, Drug Metabolism and Pharmacokinetics discusses sample topics including: ADME properties, metabolite identification, and bioanalytical strategies for oligonucleotide drugsStrategies and challenges in the determination of drug-to-antibody ratio (DAR) values of antibody-drug conjugates (ADCs)Breaking barriers in CNS drug development with intrathecal and intracerebroventricular administrationApplication and detection techniques of biomarkers in drug developmentFlux dialysis method for assessing plasma protein binding of high protein-binding drugs Drug Metabolism and Pharmacokinetics is an essential forward-thinking reference on the subject for pharmacy students, pharmaceutical industry researchers, and DMPK scientists, especially those exploring novel drug modalities.
Drug Metabolism: Chemical and Enzymatic Aspects
by Jack P. Uetrecht William TragerIn order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structure and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market. This title is a comprehensive guide for recognizing the chemica
Drug Metabolism: Chemical and Enzymatic Aspects
by Jack P. Uetrecht William TragerIn order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structures and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market. This comprehensive textbook will aid in guiding students throu
Drug Metabolizing Enzymes: Cytochrome P450 and Other Enzymes in Drug Discovery and Development
by R. Scott Obach Jae S. Lee Michael B. FisherCritical in the elimination of drugs and other xenobiotics from the body, cytochrome P450 has strong bearing on scientific assessments of genetic polymorphism in metabolism, possible drug-drug interactions, and bioavailability of candidate drugs. This text systematizes findings on P450 and similar enzymes--as well as parallel issues shaping the pharmaceutical industry--to promote the next generation of safer, more effective drugs. Topics include dioxygen activation, the identification and characterization of metabolites, bioactivation, P450 in lab animal species, enzyme kinetics, reaction phenotyping, drug-drug interactions, pharmacogenetics, hepatic clearance, and the role of UGTs.
Drug Products for Clinical Trials
by Charles F. Carney Donald C. Monkhouse James L. ClarkAddressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection o
Drug Repositioning: Approaches and Applications for Neurotherapeutics (Frontiers in Neurotherapeutics Series)
by Joel Dudley Laura BerliocchiNervous system diseases represent a major health concern worldwide. Although important financial and professional investment, their etiology and pathophysiology still remain mostly elusive. Moreover, the clinical need of disease-modifying therapies is still unmet. In the last decades, traditional R&D has failed in identifying new effective therapies in many medical areas and drug repositioning has recently emerged as a promising alternative strategy to de novo drug discovery to improve and accelerate therapeutic development. For the first time, Drug Repositioning: Approaches and Applications for Neurotherapeutics reviews history and advances in drug repositioning, with a special focus on therapeutics for nervous system diseases. International experts from Academia, Industry and Non-profit organisations will provide different views on drug repositioning advantages, challenges and specific applications, which will be covered for nervous system diseases including Alzheimer's, Parkinson's, Huntington's diseases, Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, ischemic stroke, and psychiatric disorders. This book provides a balanced overview and synthesis of drug repositioning concept, methods and applications for neurotherapeutics. It represents a valuable resource for students, scientists and clinicians working in academic settings, industry and government agencies within the fields of neuroscience, pharmacology, neurology, pharmaceutical sciences, drug discovery and development.
Drug Repurposing: Innovative Approaches to Drug Discovery and Development
by Amit Alexander Naveen Chella Om Prakash RanjanThis book offers an insightful exploration of drug repurposing, an innovative approach to drug discovery and development that has the potential to revolutionize the field of medicine. It begins with an introduction to drug repurposing and its history, providing a comprehensive overview of the subject. The readers will embark on a journey through the diverse landscape of drug repurposing strategies. From in silico methods of predicting drug-disease associations to experimental approaches to the integrations of artificial intelligence (AI) and machine learning (ML) in drug repurposing for validating repurposed candidates. The book also delves into the application of drug repurposing in various disease areas, including cancer, inflammatory disorders, and CNS disorders. It explores the potential hurdles involved in the regulatory aspects of the process. The book further covers drug products under clinical trials and provides an overview of the future perspectives of drug repurposing. With its detailed and informative content, this book is a must-read for researchers, clinicians, and healthcare professionals interested in the exciting field of drug repurposing.
Drug Resistance in Leishmania Parasites
by Maritza Padrón-Nieves Emilia Diaz Alicia Ponte-SucreOne of the main problems concerning therapeutic tools for the treatment of parasitic diseases, including leishmaniasis, is that some field parasites are naturally resistant to the classical drugs; additionally, current therapies may select parasites prone to be resistant to the applied drugs. These features are (at least partially) responsible for the disappointing persistence of the disease and resultant deaths worldwide. This book provides a comprehensive view of the pathology of the disease itself, and of parasitic drug resistance, its molecular basis, consequences and possible treatments. Scientists both from academic fields and from the industry involved in biomedical research and drug design, will find in this book a valuable and fundamental guide that conveys the knowledge needed to understand and to improve the success in combating this disease worldwide.
Drug Resistance in Leishmania Parasites: Consequences, Molecular Mechanisms And Possible Treatments
by Maritza Padrón-Nieves Alicia Ponte-SucreDrug resistance is a fundamental factor in treatment failure in diseases like leishmaniasis, although additional factors also play a role in this phenomenon. This volume is the second edition of a well-received book that provides a comprehensive update on the pathology of the disease, as well as on the concept of parasitic drug resistance, its molecular basis, consequences and possible treatments. A valuable resource for scientists both from academia and industry involved in biomedical research and drug design, the book provides the knowledge needed to understand leishmaniasis and to contibute to combatting this disease worldwide.
Drug Safety Evaluation
by Shayne Cox GadThis practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics.* Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development* Explains scientific and philosophical bases for evaluation of specific concerns - including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity* Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars* Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation* Adds almost 20% new and thoroughly updates existing content from the last edition
Drug Safety Evaluation (Pharmaceutical Development Series)
by Shayne Cox Gad Dexter W. Sullivan Jr.Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.
Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition (Drugs and the Pharmaceutical Sciences)
by Irving W. Wainer Krzysztof Józwiak W. John LoughDrug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology. Topics include:The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug disc
Drug Target Selection and Validation (Computer-Aided Drug Discovery and Design #1)
by Marcus T. Scotti Carolina L. BelleraThe first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis.Many often-overlooked approximations and concepts in drug discovery are fully covered. Drug Target Selection and Validation includes both introductory sections and research-based sections to be of use to both students and research scientists in drug discovery, design, kinetics and metabolic analysis. Pharmaceutical scientists, pharmaceutics, drug developers, pharmacologists, biomedical researchers in computer science, medicinal chemists, and precision medicine developers benefit from the information provided. The book concludes with a chapter on chemical and structural databases.
Drug Targets for Plasmodium Falciparum: Historic to Future Perspectives
by Mohammed TariqueThis book offers a comprehensive exploration of malaria, a life-threatening disease affecting millions globally, with a focus on the parasitic organisms of the genus Plasmodium that cause it. It discusses the challenges posed by the disease, especially in economically developing regions, and delves into the biology and pathophysiology of the Plasmodium species, including their genetic flexibility and resistance to treatments. Special attention is given to P. falciparum, the most dangerous of these parasites, detailing its complex life cycle, interaction with human hosts, and the severe clinical manifestations it can induce. The book further explores the global health concern of antimalarial drug resistance, highlighting the WHO's efforts in combating the disease and the necessity for novel treatments. Innovative research directions, such as targeting the unique organelles of Plasmodium like the apicoplast and employing proteasome inhibitors, are thoroughly examined as potential strategies in the development of new antimalarial drugs. Additionally, it addresses the critical role of the hemoglobin digestion process in the parasite's lifecycle, presenting it as a promising target for therapeutic intervention. This work is an essential resource for researchers, clinicians, and policymakers involved in malaria control and drug development, providing insights into the current challenges and future directions in the fight against this endemic disease.
Drug Targets in Cellular Processes of Cancer: From Nonclinical to Preclinical Models
by Hardeep Singh TuliThis book explores potential cellular drug targets for cancer therapy. The first couple of chapters describe conventional treatment (radiotherapy, chemotherapy, and immunotherapy) & detection (biosensors) strategies for cancer. In contrast, the subsequent chapters address the role of cyclin-dependent kinases and cell cycle regulatory proteins in the growth of cancer cells and their potential as target for cancer treatment. The book then discusses the regulation of various pro-apoptotic and anti-apoptotic proteins via chemotherapeutic drugs. In addition, it examines the molecular mechanisms that are critical for mediating autophagic cell death in cancer cells. It subsequently reviews the role of reactive oxygen (ROS) species during carcinogenesis and during chemotherapy, and the potential of anti-inflammatory routes for the development of new therapeutic modulators. Lastly, it describes therapeutic strategies that target the tumor microenvironment and various angiogenic pathways for the treatment of cancer and to develop personalized medicine. Given its scope, the book is valuable resource for oncologists, cancer researchers, clinicians, and pharmaceutical industry personnel.
Drug Testing Technology: Assessment of Field Applications
by Tom MieczkowskiCovering a wide range of research currently being done in drug analysis, Drug Testing Technology: Assessment of Field Applications compares and evaluates various methods used to determine abused drugs taken by individuals, and their application in various programs and contexts. Controversies associated with various methods, including urine analysis and hair analysis, are examined. Contributors from a wide diversity of disciplines offer advanced knowledge, encompassing work which is technical as well as markedly philosophical. Chapters provide overviews of drug incorporation into hair; the use of hair analysis for compliance measurement in the use of anti-epileptic medications; and the application of drug testing to the psychiatric treatment of substance abuse disorders. Drug Testing Technology: Assessment of Field Applications provides information useful in medical applications, workplace testing, criminal justice monitoring community epidemiology, and drug treatment assessment.
Drug Testing in Hair
by Pascal KintzDrug Testing in Hair is the first book on this timely and controversial topic. The book's purpose is to validate hair testing as an accepted form of evidence for use in courts and elsewhere, such as the military and the workplace. This volume presents the most recent experiments and clinical applications to provide missing information and insight into the unanswered questions of hair testing.Active researchers working in hair testing have contributed chapters to this book. New data, never before published, are incorporated into the text, so the reader receives cutting-edge information from experts in the field. This is must-have information on everything you need to know about drug testing in hair.
Drug Toxicity and Metabolism in Pediatrics
by Sam KacewThe aim of this text is to examine the physiological development of the fetus. It allows the reader to study the unique pharmacokinetic and metabolic features of newborns and gives specific examples of drug metabolism in the newborn. The purpose of this book is to enhance the current knowledge of pharmacology of the newborn by observing the embryo and placenta in normal and abnormal development, placental transfer of drugs, metabolic pathways, and metabolism of specific drugs such as theophylline, benzodiazepines, and antibiotics. This is a useful book for those involved in pediatric research, pharmacology, toxicology, experimental therapeutics and biology.
Drug Transporters
by Binghe Wang Guofeng You Marilyn E. MorrisThis new edition overviews drug transporters and presents the principles of drug transport and associated techniques, featuring new chapters on multidrug and toxin extrusion proteins, placental transport, in silico approaches in drug discovery, and regulatory guidance for drug transport studies in drug development. * Describes drug transporter families, mechanisms, and clinical implications along with experimental methods for studying and characterizing drug transporters * Includes new chapters on multidrug and toxin extrusion proteins, placental transport and in silico approaches in drug discovery * Has a new chapter covering regulatory guidance for the evaluation of drug transport in drug development with global criteria used for drug transporters in clinical trials * Arranges material to go from fundamental mechanisms to clinical outcomes, making the book useful for novice and expert readers
Drug Transporters in Drug Disposition, Effects and Toxicity (Advances in Experimental Medicine and Biology #1141)
by Xiaodong Liu Guoyu PanThis book provides with a comprehensive overview of the role of drug transporters in drug disposition and efficacy/toxicity, as well as drug-drug interactions and recent advances in the field. Transporters are known determinants of drug disposition and efficacy/toxicity. In general, they are divided into solute carrier (SLC) and ATP binding cassette (ABC) families, and are located along cell membranes, where they mediate drug uptake into cells and export out of cells. Drug transporters are essential in maintaining cell homeostasis, and their gene mutations may cause or contribute to severe human genetic disorders, such as cystic fibrosis, neurological disease, retinal degeneration, anemia, and cholesterol and bile transport defects. Conversely, some diseases may also alter transporter functions and expressions, in turn aggravating disease process. Further, since over-expression of some ABC transporters is a potential contributor to multidrug-resistance (MDR), the book presents a number of strategies to overcome MDR, including ABC transporter inhibitors and applying epigenetic methods to modulate transporter expressions and functions. This book is useful for graduate students and professionals who are looking to refresh or expand their knowledge of this exciting field.
Drug Transporters: Molecular Characterization and Role in Drug Disposition (Wiley Series in Drug Discovery and Development)
by Binghe WangDRUG TRANSPORTERS Drug transporter fundamentals and relevant principles and techniques, featuring new and expanded chapters Drug Transporters: Molecular Characterization and Role in Drug Disposition provides in-depth analysis of the conceptual evolution and technical development for studying drug transporters. Contributions by an international panel of leading researchers address advances in transporters as drug targets, transporters in pharmacotherapy, the impact of transporters on drug efficacy and safety, the development of sophisticated model systems and sensitive assay methods, and more. Divided into two parts, the book first provides a thorough overview of relevant drug transporters before detailing the principles of drug transport and associated techniques. The updated and expanded third edition includes new chapters on in vitro-in vivo scale-up of drug transport activities, the ontogeny of drug transporters, the application of physiologically-based pharmacokinetic and pharmacodynamic modeling, and the use of transporters as therapeutic targets for diseases. Reflects the current state of the field and offers perspectives on future directions Covers basic knowledge, clinical outcomes, and emerging discoveries in transporter science Provides up-to-date information on drug transporter families, mechanisms, and clinical implications Includes extensive references and numerous figures and tables throughout Understandable for novices while offering sufficient depth for more experienced researchers, Drug Transporters: Molecular Characterization and Role in Drug Disposition, Third Edition is an excellent textbook for pharmacological or physiological science courses in drug/membrane transport, and an invaluable reference for academic or industrial scientists working in the transporter field and related areas of drug metabolism, pharmacokinetics, and pharmacodynamics.
Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear
by Dr. Carl L. HartFrom one of the world's foremost experts on the subject, a powerful argument that the greatest damage from drugs flows from their being illegal, and a hopeful reckoning with the possibility of their use as part of a responsible and happy lifeDr. Carl L. Hart, Ziff Professor at Columbia University and former chair of the Department of Psychology, is one of the world's preeminent experts on the effects of so-called recreational drugs on the human mind and body. Dr. Hart is open about the fact that he uses drugs himself, in a happy balance with the rest of his full and productive life as a colleague, husband, father, and friend. In Drug Use for Grown-Ups, he draws on decades of research and his own personal experience to argue definitively that the criminalization and demonization of drug use--not drugs themselves--have been a tremendous scourge on America, not least in reinforcing this country's enduring structural racism.Dr. Hart did not always have this view. He came of age in one of Miami's most troubled neighborhoods at a time when many ills were being laid at the door of crack cocaine. His initial work as a researcher was aimed at proving that drug use caused bad outcomes. But one problem kept cropping up: the evidence from his research did not support his hypothesis. From inside the massively well-funded research arm of the American war on drugs, he saw how the facts did not support the ideology. The truth was dismissed and distorted in order to keep fear and outrage stoked, the funds rolling in, and Black and brown bodies behind bars. Drug Use for Grown-Ups will be controversial, to be sure: the propaganda war, Dr. Hart argues, has been tremendously effective. Imagine if the only subject of any discussion about driving automobiles was fatal car crashes. Drug Use for Grown-Ups offers a radically different vision: when used responsibly, drugs can enrich and enhance our lives. We have a long way to go, but the vital conversation this book will generate is an extraordinarily important step.
Drug-DNA Interaction Protocols
by Keith R. FoxIn Drug-DNA Interactions, expert researchers describe powerful molecular techniques designed to illuminate and explore the interaction of drugs and ligands with DNA, often perfected in their own laboratories, . These easily reproducible methods involve sequence recognition properties, as well as physical approaches to measuring both the strength of interaction and the mode of drug binding to DNA. Drug interactions are also examined from a cellular perspective and for their usefulness in the development of new therapeutic agents. <P><P> Drug-DNA Interactions will be highly useful to all investigators needing the kind of detailed experimental and technical information often omitted from scientific papers. Those wishing to expand their repertoire of experimental techniques or to improve their current techniques will also find these powerful methods particularly helpful in elucidating the action of existing therapeutic agents, as well as in designing new anticancer drugs with improved action and reduced toxicity.
Drug-DNA Interaction Protocols, 2nd Edition
by Keith R. FoxThe last few years have witnessed the creation of new generations of sequence reading compounds, which have incredible potential for targeting specific DNA sequences. In "Drug-DNA Interaction Protocols, Second Edition", expert researchers explore these compounds, revealing how a deeper understanding of the structure of DNA, along with an improved ability to manipulate it, has led to much progress in recent years. Chapters describe a new arsenal of techniques for probing the interactions between drugs and DNA, including various biophysical techniques for quantifying these interactions and for describing them in molecular and atomic detail, and they comprehensively consider both molecular and cellular approaches. Composed in the highly successful Methods in Molecular BiologyTM series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls.<P><P> Authoritative and current, "Drug-DNA Interaction Protocols, Second Edition", is a critical volume that includes a wide range of chapters, which together provide methods for assessing the strength and mode of binding, the sequence selectivity, and the effect on biological systems.
Drug-Drug Interactions for Therapeutic Biologics
by Bernd Meibohm Honghui ZhouStrategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologicsOffering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions.Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as:Drug-drug interaction risks in combination with small molecules and other biologicsPharmacokinetic and pharmacodynamic drug-drug interactionsIn vitro methods for drug-drug interaction assessment and predictionRisk-based strategies for evaluating biologic drug-drug interactionsStrategies to minimize drug-drug interaction risk and mitigate toxic interactionsKey regulations governing drug-drug interaction assessments for therapeutic biologics.Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.