Get Up to Speed on Many Types of Adaptive Designs Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials. New to the Second Edition Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials Twenty new SAS macros and R functions Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

Biotechnology in the Modern Medicinal System: Advances in Gene Therapy, Immunotherapy, and Targeted Drug Delivery presents an informative picture of the state-of-the-art research and development of actionable knowledge in medical biotechnology, specifically involving gene therapy, immunotherapy, and targeted drug delivery systems. The book includes novel approaches for therapy of various ailments and the real-world challenges and complexities of the current drug delivery methodologies and techniques. The volume helps to bridge the gap between academic research and real-time clinical applications and the needs of medical biotechnology methods. This edited book also provides a detailed application of medical biotechnology in drug discovery and the treatment of various deadly diseases. Chapters discuss targeted drug delivery to specific sites to avoid possible entry to non-targeted sites, minimizing adverse effects. The volume provides information about the roles of alternative routes of drug targeting, like intranasal and transdermal, resulting in improving patient compliance. Targeted drug delivery is explored for several health issues, such as neurodegenerative disorders, cancer, malaria, and hemoglobin disorders. Also considered is the role of genes in various genetic diseases and gene therapy, and immunogene therapy as alternative approaches to conventional cancer therapy. Finally, the book investigates the important role of computers in biotechnology to accelerate research and development in the modern medicinal field for better and optimum results. Studies show that significant improvement has been observed in the development of a faster and less invasive diagnostic system for the treatment of diseases by utilizing both artificial intelligence (AI) and biotechnology. This valuable volume provides a wealth of information that will be valuable to scientists and researchers, faculty, and students.

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

Defines best practices for leveraging of discovery research to facilitate a science-based, rational, and predictive preclinical development program to ensure clinical efficacy and safety Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications

During the past decade, the importance of amorphous water-soluble substances has been increasingly recognised within the food and pharmaceutical industries. In response, Amorphous Food and Pharmaceutical Systems brings together current leading experts to contribute to this unique cross-disciplinary account of the subject. Coverage includes: water-compatible amorphous solids (physical, chemical behaviour), low water content systems (water as plasticizer); applications in food and pharmaceutical sciences and industries (processing and stability) along with state-of-the-art technology in food and pharmaceutical systems. This timely publication will be welcomed by academic and industrial researchers and professionals in the pharmaceuticals, food, materials and polymer sciences.

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products-from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval. Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug product performance ANDA regulatory process Post-approval changes Post-marketing surveillance Legislative and patent challenges This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.

The pace and sophistication of advances in medicine in the past two decades have necessitated a growing need for a comprehensive reference that highlights current issues in medicine. Each volume in the Current Issues in Medicine series is a stand-alone text that provides a broad survey of various critical topics-all accomplished in a user-friendly yet interconnected format. The series not only highlights current advances but also explores related topics such as translational medicine, regulatory science, neglected diseases, global pandemics, patent law, immunotoxicology, theranostics, big data, artificial intelligence, novel imaging tools, combination drug products, and novel therapies. While bridging the gap between basic research and clinical medicine, this series provides a thorough understanding of medicine's potential to address health problems from both the patient's and the provider's perspectives in a healthcare setting. The range of topics covered and the expertise of the contributing authors accurately reflect the rapidly evolving areas within medicine-from basic medical sciences to clinical specialties. Each volume is essential reading for physicians, medical students, nurses, fellows, residents, undergraduate and graduate students, educators, policymakers, and biomedical researchers. The multidisciplinary approach of the series makes it a valuable reference resource for the pharmaceutical industry, academia, and governments. However, unlike other series on medicine or medical textbooks, this series focuses on current trends, perspectives, and issues in medicine that are central to healthcare delivery in the 21st century. Volume 1 focuses on the current issues in basic medical sciences, subjects that are fundamental to the practice of medicine. Specifically, it covers medical biochemistry, genomics, physiology, and pathology. These subjects, traditionally taught in the first two years of medical school that precede clinical instruction, provide a core of basic knowledge critical to the success in clinical medicine during rotations, training, and medical practice.

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.

Hugo Chavez won re-election in the 2012 Venezuelan presidential election, despite a closer margin between candidates than in previous elections. The results were puzzling for those who believed that Chavez's government had long ago reached its limits, while Chavez's supporters were struck by the growth of the opposition vote. Thus understanding the Venezuelan election of 2012 has proved to be challenging, with various recent studies focused upon it. Luis F. Angosto Ferrandez's book advances two ideas not previously discussed: the relationship between electoral behavior in Venezuela and contemporary Latin American geopolitics, and the way that relationship is projected through the candidates' appeal to narratives that situate Venezuela at the core of a heroic Latin American tradition and of a new regional process of integration. This edited volume first contextualizes and explains the results of the last re-election of Hugo Chavez in terms of its geopolitical conditionings and implications. Contributors tackle Latin American geopolitics by analyzing Venezuelan foreign policy and the country's role in continental projects of supra-national integration. Contributors also examine electoral strategy and tactics in order to show how the two main candidates built their campaign on emotional grounds as much on rational ones. This will be connected to the investigation of new narratives of national identification in contemporary Venezuela and how they may have practical implications in the design of policies addressing issues such as indigenous rights, community media and national security. Compiling state-of-the-art research on Latin American and Venezuelan politics, this book will appeal to academics and professionals who specialize in Latin American studies, international relations, democracy, and indigenous peoples.

There is an increasing interest in plants of the Moringa genus used as a source of phytochemicals with biopharmaceutical potential, as a functional ingredient in many products and as an additive in poultry feeding stocks. Biological and Pharmacological Properties of the Genus Moringa is the first publication to comprehensively assess the latest research on Moringa studies. This book reviews recent studies covering the botanical, agronomical, genomic, biotechnological, and ethnopharmacological aspects. It presents specialized work in a user-friendly way that will appeal to undergraduates, graduates and researchers primarily in ethnopharmacology, functional foods and with a linkage to veterinary treatments. Key Features: Describes the ethnopharmacological and ethnobotanical use of plants from all Moringa species Presents recent information that will be helpful for the future development of biopharmaceuticals Reviews the phytochemical content from all Moringa species Assesses the potential of all Moringa species as a functional ingredient

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.

Increase in antibiotic resistance has forced researchers to develop new drugs against microorganisms. Lipopeptides are produced as secondary metabolites by some microorganisms. Computer-aided Design of Antimicrobial Lipopeptides as Prospective Drug Candidates provides the identification of novel ligands for different antimicrobial lipopeptides. Along with identification, it also provides some of the in silico drug design processes, namely homology modelling, molecular docking, QSAR studies, drug ADMET studies and pharmacophore studies to check the ligand-lipopeptide interaction. Some lipopeptides have shown anti-cancerous properties too, and this book discusses the required templates to design new drugs using computational techniques. Key Features: Focuses on the use lipopeptides as new antimicrobial compounds Presents the basics of in silico modelling for design and development of new drug molecules, and is therefore of interest to beginners in the field Provides a step-by-step process for identification of drug molecules and testing its efficacy in silico Couples with courses on patents and intellectual property rights

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.

There is a clear need for innovative technologies to improve the delivery of therapeutic and diagnostic agents in the body. Recent breakthroughs in nanomedicine are now making it possible to deliver drugs and therapeutic proteins to local areas of disease or tumors to maximize clinical benefit while limiting unwanted side effects. Nanomedicine in Drug Delivery gives an overview of aspects of nanomedicine to help readers design and develop novel drug delivery systems and devices that build on nanoscale technologies. Featuring contributions by leading researchers from around the world, the book examines: The integration of nanoparticles with therapeutic agents The synthesis and characterization of nanoencapsulated drug particles Targeted pulmonary nanomedicine delivery using inhalation aerosols The use of biological systems-bacteria, cells, viruses, and virus-like particles-as carriers to deliver nanoparticles Nanodermatology and the role of nanotechnology in the diagnosis and treatment of skin disease Nanoparticles for the delivery of small molecules, such as for gene and vaccine delivery The use of nanotechnologies to modulate and modify wound healing Nanoparticles in bioimaging, including magnetic resonance, computed tomography, and molecular imaging Nanoparticles to enhance the efficiency of existing anticancer drugs The development of nanoparticle formulations Nanoparticles for ocular drug delivery Nanoparticle toxicity, including routes of exposure and mechanisms of toxicity The use of animal and cellular models in nanoparticles safety studies With its practical focus on the design, synthesis, and application of nanomedicine in drug delivery, this book is a valuable resource for clinical researchers and anyone working to tackle the challenges of delivering drugs in a more targeted and efficient manner. It explores a wide range of promising approaches for the diagnosis and treatment of diseases using cutting-edge nanotechnologies.

Pharmaceutical science deals with the whole spectrum of drug development from start to finish. There are many different facets to the pharmaceutical industry, from initial research to the finished product, including the equipment used, trials performed, and regulations that must be followed. Presenting an overview of all of these different aspects, the Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition is a must-have reference guide for all laboratories and libraries in the pharmaceutical field. Bringing together leaders from every specialty related to pharmaceutical science and technology, this is the single-source reference at the forefront of pharmaceutical R&D. The strength of this work is not only its breadth but also the caliber of contributing writers, all experts in their field, writing on all aspects of pharmaceutical science and technology. The fourth edition offers 29 new chapters ranging from biomarkers, computational chemistry, and contamination control to high-throughput screening, orally disintegrating tablets, and quality by design. The encyclopedia details best practices of equipment used, methods for manufacturing, options for packaging, and routes for drug delivery. The volumes also provide a thorough understanding of the choices behind each method. In addition, the regulations, safety aspects, patent guidance, and methods of analysis are presented. Key Areas Covered: Analytics Biomarkers Dosage forms Drug delivery Formulation Informatics Manufacturing Packaging Processing Regulatory affairs Systems validation This is an authoritative reference source for those practicing in any area of pharmaceutical science and technology, enabling the pharmaceutical specialist and novice alike to keep abreast of developments in this constantly evolving and highly competitive field.

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;}

Covers micro- and Nano- technologies approaches with current trends with safety and efficacy in product development. Presents overview of recent progress of stability testing, reverse engineering, validation and regulatory perspectives as per regulatory requirements. Provides comprehensive overview of latest research related to the micro and nanotechnological including designing, optimization, validation, scale of micro and nanotechnologies. This book is edited by the two-well known researchers by contribution of the vivid chapters from renowned scientists across the globe in field of pharmaceutical sciences.

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.

In a living body, a variety of molecules are working in a concerted manner to maintain its life, and to carry forward the genetic information from generation to generation. A key word to understand such processes is "water," which plays an essential role in life phenomena. This book sheds light on life phenomena, which are woven by biomolecules as warp and water as weft, by means of statistical mechanics of molecular liquids, the RISM and 3D-RISM theories, both in equilibrium and non-equilibrium. A considerable number of pages are devoted to basics of mathematics and physics, so that students who have not majored in physics may be able to study the book by themselves. The book will also be helpful to those scientists seeking better tools for the computer-aided-drug-discovery. Explains basics of the statistical mechanics of molecular liquids, or RISM and 3D-RISM theories, and its application to water. Provides outline of the generalized Langevin theory and the linear response theory, and its application to dynamics of water. Applies the theories to functions of biomolecular systems. Applies the theories to the computer aided drug design. Provides a perspective for future development of the method.

Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence of the COVID-19 virus has brought lung and lung delivery systems into focus, this book covers new developments and research used to address the prevention and treatment of respiratory diseases. Written by well-known scientists with years of experience in the field this timely handbook is an excellent reference book for the scientists and industry professionals. Key Features: Focuses particularly on the chemistry, clinical pharmacology, and biological developments in this field of research. Presents comprehensive information on emerging nanotechnology applications in diagnosing and treating pulmonary diseases Explores drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications Examines specific formulations targeted to pulmonary systems

Diverse and abundant, marine-derived bioactive compounds offer a plethora of pharmacologically active agents with the potential to produce valuable therapeutic entities. Marine-derived organisms, including some macroalgae, microalgae, blue-green algae, invertebrates, and vertebrates-valued in traditional Chinese medicine since ancient times-are now recognized as rich sources of pharmaceutically active compounds. These factors, coupled with the growing need for novel bioactives for the treatment of severe human diseases such as cancer, diabetes, microbial infections, and inflammatory processes, has brought marine pharmaceuticals to the forefront of pharmacology. Marine Pharmacognosy: Trends and Applications provides a comprehensive account of marine-derived bioactive pharmaceuticals and their potential health benefits, including antioxidant, anticancer, antiviral, anticoagulant, antidiabetic, antiallergy, anti-inflammatory, antihypertensive, antibacterial, and radioprotective activities. Moreover, it discusses the sources, isolation and purification, chemistry, functionality interactions, applications, and industrial features of a variety of marine-derived pharmaceuticals. Marine pharmacognosy is a dynamic field that has been systematically investigated over the last 50 years, and the number of publications and patents are increasing every year. Bringing together a global team of experts, Marine Pharmacognosy: Trends and Applications reviews current research on marine-derived bioactive compounds and provides insight into future research on their potential as pharmacologically active agents.

Encapsulation of bioactives is a fast-growing approach in the food and pharmaceutical industry. Spray Drying Encapsulation of Bioactive Materials serves as a source of information to offer specialized and in-depth knowledge on the most well-known and used encapsulation technology (i.e., spray drying) and corresponding advances. It describes the efficacy of spray drying in terms of its advantages and challenges for encapsulation of bioactive ingredients. Discusses the potential of this technique to pave the way toward cost-effective, industrially relevant, reproducible, and scalable processes that are critical to the development of delivery systems for bioactive incorporation into innovative functional food products and pharmaceuticals Presents the latest research outcomes related to spray drying technology and the encapsulation of various bioactive materials Covers advances in spray drying technology that may result in a more efficient encapsulation of bioactive ingredients Includes computational fluid dynamics, advanced drying processes, as well as the morphology of the dried particles, drying kinetics analyzers, process controllers and adaptive feedback systems, inline powder analysis technologies, and cleaning-in-place equipment Aimed at food manufacturers, pharmacists, and chemical engineers, this work is of interest to anyone engaged in encapsulation of bioactive ingredients for both nutraceutical and pharmaceutical applications.

Provides an understanding of (mostly) enzymatic reactions that are responsible for the function and maintenance of living things This innovative text for non-biochemistry majors includes introductory material at the beginning of each chapter that contextualizes chapter themes in real-life scenarios Online supporting materials with further opportunities for research and investigation Synthesis questions at the end of each chapter that encourage students to make connections between concepts and ideas, as well as develop critical-thinking skills

Medicinal Chemistry: A Look at How Drugs Are Discovered is written for those who are interested in learning how drugs are discovered. Compared to other books on the market, this text takes a different approach by presenting the subject on chemical reaction mechanism terms, which ideally makes the subject matter more interesting and easier to comprehend. The authors describe the drug discovery process, from advancing an initial lead to the approval process, and include drug discovery sources. Additional features: Explains medicinal chemistry on chemical mechanism terms, allowing for a more interesting and easier to comprehend text Includes valuable insights toward the various pathways taken at pharmaceutical industries in drug discoveries Improved by including questions raised and suggestions made from students in the authors' medicinal chemistry classes This book will benefit both upper level undergraduates and graduates studying in the fields of medicinal chemistry and drug discovery, as well as scientists working in the pharmaceutical industry.

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