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Mitchell Cayen N. Early Drug Development. Strategies and Routes to First-in-Human Trials


The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

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Dimitri Semizarov Genomics in Drug Discovery and Development


Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

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Raimund Mannhold Early Drug Development


This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

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Lu Chuang Enzyme Inhibition in Drug Discovery and Development. The Good and the Bad


The science and applied approaches of enzyme inhibition in drug discovery and development Offering a unique approach that includes both the pharmacologic and pharmaco-kinetic aspects of enzyme inhibition, Enzyme Inhibition in Drug Discovery and Development examines the scientific concepts and experimental approaches related to enzyme inhibition as applied in drug discovery and drug development. With chapters written by over fifty leading experts in their fields, Enzyme Inhibition in Drug Discovery and Development fosters a cross-fertilization of pharmacology, drug metabolism, pharmacokinetics, and toxicology by understanding the «good» inhibitions—desirable pharmacological effects—and «bad» inhibitions—drug–drug interactions and toxicity. The book discusses: The drug discovery process, including drug discovery strategy, medicinal chemistry, analytical chemistry, drug metabolism, pharmacokinetics, and safety biomarker assessment The manipulations of drug metabolizing enzymes and transporters as well as the negative consequences, such as drug–drug interactions The inhibition of several major drug target pathways, such as the GPCR pathway, the NFkB pathway, and the ion channel pathway Through this focused, single-source reference on the fundamentals of drug discovery and development, researchers in drug metabolism and pharmacokinetics (DMPK) will learn and appreciate target biology in drug discovery; discovery biologists and medicinal chemists will also broaden their understanding of DMPK.

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Urban Laszlo Predictive ADMET. Integrated Approaches in Drug Discovery and Development


This book helps readers integrate in silico, in vitro, and in vivo ADMET (absorption, distribution, metabolism, elimination and toxicity) and PK (pharmacokinetics) data with routine testing applications so that pharmaceutical scientists can diagnose ADMET problems and present appropriate recommendations to move drug discovery programs forward. The book introduces the current clinical practice for drug discovery and development along with the impact on early risk assessment; consolidates the tools and models to intelligently integrate existing in silico, in vitro and in vivo ADMET data; and demonstrates successful cases and lessons learned from real drug discovery and development. In short, it is a book aimed to provide a practical road map for drug discovery and development scientists to generate efficacious and safe drugs for unmet medical needs.

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Группа авторов Molecular Pathology in Drug Discovery and Development


Covers powerful new tools for drug development Molecular pathology offers tools and techniques that can greatly enhance the drug discovery and development process, helping to make the promises of personalized medicine a reality. Molecular Pathology in Drug Discovery and Development provides an unmatched guide to this cutting-edge discipline and its applications to pharmaceutical science. With contributions from leading lights in drug discovery, drug development, and molecular pathology balanced by a consistent editorial approach, this reference offers both an overview of molecular pathology and a close look at the methods as they are applied to the process of drug discovery and development. Presented as steps in the drug development process, the coverage includes the use of molecular pathology to: Identify and validate new drug candidates Enhance transcriptional profiling to better find and validate biomarkers Assess toxicology Employ toxicogenomics to identify genes relevant to the safety of compounds Identify correct doses for different drugs Identify patients for treatment Develop molecular therapies Further the new techniques of Immunohistochemistry and Immunofluorescence With many tests and treatments already working today, drug research and development using molecular pathology has shown itself an extremely fruitful area. Molecular Pathology in Drug Discovery and Development gives practitioners an up-to-date resource on this highly active discipline and its role in furthering pharmaceutical research.

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Binghe Wang Drug-Drug Interactions in Pharmaceutical Development


Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.

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Группа авторов Innovative Dosage Forms


Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

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Mike Lee S. LC/MS Applications in Drug Development


Breakthroughs in combinatorial chemistry and molecular biology, as well as an overall industry trend toward accelerated development, mean the rate of sample generation now far exceeds the rate of sample analysis in the pursuit of producing new and better pharmaceuticals. LC/MS is an analytical tool that helps the researcher identify the most promising sample early in the selection process, effectively creating a shortcut to finding new drugs. This book is the first to describe LC/MS applications within the context of drug development, including the discovery, preclinical, clinical, and manufacturing phases. In addition to the thorough technical analysis of this tool, LC/MS Applications in Drug Development provides perspective on the significant changes in strategies for pharmaceutical analysis. A process overview of drug development from an analytical point of view is provided along with essential data required to successfully bring a drug to market. The incorporation of LC/MS is illustrated from target to product. Chapters pertaining to the discovery process itself include: Proteomics Glycoprotein Mapping Natural Products Dereplication Lead Identification Screening Open-Access LC/MS In Vitro Drug Screening Written for both the analytical chemist who uses LC/MS applications and the pharmaceutical scientist who works with the drugs they produce, LC/MS Applications in Drug Development is the premier reference on the subject.

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Litwin Virginia Flow Cytometry in Drug Discovery and Development


This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

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[원서] Mitchell N. Cayen - Early Drug Development Strategies ...

Download : Mitchell N Cayen Early Drug Development Strategies and Routes to First in Human Trials (2010).pdf( 31 ) 순서 [원서] Mitchell N. Cayen - Early Drug Development Strategies and Routes to First-in-Human Trials (2010)

Mitchell N. Cayen (Author of Drug Development)

Mitchell N. Cayen is the author of Drug Development (0.0 avg rating, 0 ratings, 0 reviews, published 2010)

Porsche Cayenne | mobile.de

Der Cayenne stand von Anfang an für sportliche Fahrleistungen in Verbindung mit großzügigen Platzverhältnissen und luxuriöser Ausstattung. Lange Zeit sperrte sich Porsche gegen den Diesel. Als er schließlich eingeführt wurde, machte er in Deutschland schnell die meisten Verkäufe aus – und zog Porsche mit in den Dieselskandal. Analog zu 911 oder Panamera gibt es den Cayenne in den ...

Joni Mitchell Archives Vol.1:the Early Years - Mitchell ...

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Joni Mitchell in Philly - The Early Years | dosage MAGAZINE

Including Mitchell’s first known tape – a 1963 Canadian radio performance of the blues standard, “House Of The Rising Sun” – along with early home demos and initial live performances. Combine those with a new interview between Mitchell and film director and writer Cameron Crowe and a detailed collection of liner notes, and Joni Mitchell Archives Vol. 1: The Early Years (1963-1967) is ...

Joni Mitchell Archives – Vol. 1: The Early Years (1963 ...

Joni Mitchell Archives – Vol. 1: The Early Years (1963–1967) is a five-disc box set by Canadian singer-songwriter Joni Mitchell, released on October 30, 2020, by Rhino Records. The box set is the first release of the Joni Mitchell Archives, a planned series of releases containing remastered material from the singer's archives. Formatted in chronological order, the first volume of the ...

Peter Mitchell - Early Sunday Morning – RRB Photobooks

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Porsche Cayenne S - Porsche Deutschland

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Mitchell Early - Finance Director - General Motors | LinkedIn

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Utah Jazz guard Donovan Mitchell isn’t a fan of how his team performs early during games. The 24-year-old All-Star lamented their slow start on Tuesday after they were blown out by the Brooklyn ...

Mitchell College program approved for Early Childhood ...

Mitchell’s Early Childhood Studies degree offers innovative educational practice designed around the National Association for the Education of Young Children (NAEYC) standards. Students gain an understanding of developmentally appropriate practice, the skills to implement lessons, a base in language, literacy, math, and science; and the expertise in assessment and observation needed to work ...

Cleta Mitchell, a key figure in president’s phone call ...

Cleta Mitchell, a key figure in president’s phone call, was an early backer of Trump’s election fraud claims

Sharon mitchell • Schnell einkaufen

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Joni Mitchell Archives, Vol. 1: The Early Years 1963-1967 ...

Joni Mitchell Archives, Vol. 1: The Early Years 1963-1967 fills in an important chapter that heretofore has gone undocumented through in her official discography: her formative years as a folkie, playing intimate venues and radio stations while recording the occasional demo or gift tape at home. It's every manner of amateur recording, spanning a period from when Mitchell first started singing ...

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Joni Mitchell - Early Joni - 1963 (2020, 180g, Vinyl ...

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Joni Mitchell: Archives Volume 1: The Early Years (5 CDs ...

Archives Vol. 1: The Early Years (1963 - 1967) erscheint als 5CD-Collection mit fast sechs Stunden unveröffentlichter Tonaufnahmen. Neben ihren ersten bekannten Aufnahmen überhaupt sind darin auch diverse Home-Demos und Live-Mitschnitte enthalten, die die prägenden Entwicklungen ihrer Anfangsjahre als Performerin und Songwriterin porträtieren.

Joni Mitchell: Archives Vol.1: The Early Years album ...

A box set like this is not intended for casual fans, nor for those for whom Joni Mitchell’s work starts and ends with an annual festive spin of River. Incredibly comprehensive, and including cuts that most have never heard before, this five-disc anthology covering Mitchell’s early years, way before the release of her 1968 debut album Song To A Seagull, is a gift for completists, music ...

Early Joni - 1963 1LP Limited Edition ... - Joni Mitchell

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Fotobücher | MITCHELL, Peter - Early Sunday Morning ...

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Joni Mitchell - Archives Volume 1: The Early Years 1963 ...

View credits, reviews, tracks and shop for the 2020 Box Set release of Archives Volume 1: The Early Years 1963-1967 on Discogs. Label: Rhino Records (2) - R2 604555,Rhino Records (2) - 603497849963 • Series: Joni Mitchell Archives - 1 • Format: Box Set 5x, CD • Country: Europe • Genre: Rock • Style: Folk. Label: Rhino Records (2) - R2 604555,Rhino Records (2) - 603497849963 ...

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Marlin girls jump on Oahe early for second win | The ...

FORT PIERRE -- The Mitchell Marlins girls hockey team scored three goals in the third period to snap a seven game losing streak with a 6-1 win over Oahe on Saturday. Brooke Jarman scored a short ...

Porsche Cayenne - autobild.de

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Pastor Carl E. Mitchell III - Early Morning Prayer with ...

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CD-Kritik Joni Mitchell Archives – Vol. 1: The Early Years ...

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Mitchell Trubisky (born August 20, 1994) is an American football quarterback for the Chicago Bears of the National Football League (NFL). He played college football at North Carolina, and was drafted by the Bears with the second overall pick in the 2017 NFL Draft. Early life. Trubisky was born in Mentor, Ohio. He attended Mentor High School where he played for the Cardinals football team ...

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Joni Mitchell Gets First Vault Collection With 'Archives ...

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Huang Xianhai Case Studies in Modern Drug Discovery and Development


Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.

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Группа авторов Mass Spectrometry for Drug Discovery and Drug Development


Facilitates the discovery and development of new, effective therapeutics With coverage of the latest mass spectrometry technology, this book explains how mass spectrometry can be used to enhance almost all phases of drug discovery and drug development, including new and emerging applications. The book's fifteen chapters have been written by leading pharmaceutical and analytical scientists. Their contributions are based on a thorough review of the current literature as well as their own experience developing new mass spectrometry techniques to improve the ability to discover and develop new and effective therapeutics. Mass Spectrometry for Drug Discovery and Drug Development begins with an overview of the types of mass spectrometers that facilitate drug discovery and development. Next it covers: HPLC–high-resolution mass spectrometry for quantitative assays Mass spectrometry for siRNA Quantitative analysis of peptides Mass spectrometry analysis of biological drugs Applications that support medicinal chemistry investigations Mass spectrometry imaging and profiling Throughout the book, detailed examples underscore the growing role of mass spectrometry throughout the drug discovery and development process. In addition, images of mass spectra are provided to explain how results are interpreted. Extensive references at the end of each chapter guide readers to the primary literature in the field. Mass Spectrometry for Drug Discovery and Drug Development is recommended for readers in pharmaceutics, including medicinal chemists, analytical chemists, and drug metabolism scientists. All readers will discover how mass spectrometry can streamline and advance new drug discovery and development efforts.

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Группа авторов Drug Discovery and Development, Volume 2


From first principles to real-world applications-here is the first comprehensive guide to drug discovery and development Modern drug discovery and development require the collaborative efforts of specialists in a broadarray of scientific, technical, and business disciplines-from biochemistry to molecular biology, organic chemistry to medicinal chemistry, pharmacology to marketing. Yet surprisingly, until now, there were no authoritative references offering a complete, fully integrated picture of the process. The only comprehensive guide of its kind, this groundbreaking two-volume resource provides an overview of the entire sequence of operations involved in drug discovery and develop-?ment-from initial conceptualization to commercialization to clinicians and medical practitioners. Volume 1: Drug Discovery describes all the steps in the discovery process, including conceptualizing a drug, creating a library of candidates for testing, screening candidates for in vitro and in vivo activity, conducting and analyzing the results of clinical trials, and modifying a drug as necessary. Volume 2: Drug Development delves into the nitty-gritty details of optimizing the synthetic route, drug manufacturing, outsourcing, and marketing-including drug coloring and delivery methods. Featuring contributions from a world-class team of experts, Drug Discovery and Development: Features fascinating case studies, including the discovery and development of erythromycin analogs, Tagamet, and Ultiva (remifentanil) Discusses the discovery of medications for bacterial infections, Parkinson's disease, psoriasis, peptic ulcers, atopic dermatitis, asthma, and cancer Includes chapters on combinatorial chemistry, molecular biology-based drug discovery, genomics, and chemogenomics Drug Discovery and Development is an indispensable working resource for industrial chemists, biologists, biochemists, and executives who work in the pharmaceutical industry.

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Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies


This book provides a comprehensive overview of the development of metabolic syndrome, the underlying mechanisms and therapeutic strategies for drug development. The authors examine the context of underlying molecular pathways and integrated physiology, then expanding the discussion to diseases associated with metabolic syndrome. The development of drug therapies for these diseases and complications is extensively covered. The book offers a comprehensive and in-depth view of energy metabolism, metabolic tissues and pathways, molecular mechanism-based drug discovery and clinical implications.

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Rossi John J. RNA Interference. Application to Drug Discovery and Challenges to Pharmaceutical Development


RNA Interference: Application to Drug Discovery and Challenges to Pharmaceutical Development provides a general overview of this rapidly emerging field, with a strong emphasis on issues and aspects that are important to a drug development team. The first part covers more general background of RNA interference and its application in drug discovery. In the second part, the book addresses siRNA (small interfering RNA), a pharmaceutically potent form, and its use and delivery in therapeutics along with manufacturing and delivery aspects.

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Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies


This book provides a comprehensive overview of the development of metabolic syndrome, the underlying mechanisms and therapeutic strategies for drug development. The authors examine the context of underlying molecular pathways and integrated physiology, then expanding the discussion to diseases associated with metabolic syndrome. The development of drug therapies for these diseases and complications is extensively covered. The book offers a comprehensive and in-depth view of energy metabolism, metabolic tissues and pathways, molecular mechanism-based drug discovery and clinical implications.

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Zhou Honghui Drug-Drug Interactions for Therapeutic Biologics


Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering 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 biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key 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.

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Jie Jack Li Contemporary Drug Synthesis


An integrated and insightful look at successful drug synthesis in today's drug discovery market The pharmaceutical industry is unquestionably vibrant today, with drug synthesis making a vital contribution. Whether in the early developmental stages of identifying and optimizing a lead, or the latter stages of process development and cost-effective scale-up, the ability to design elegant and economical synthetic routes is often a major factor in the eventual viability and commercial success of a drug. Contemporary Drug Synthesis examines how leading researchers and manufacturers have integrated chemistry, biology, pharmacokinetics, and a host of other disciplines in the creation and development of leading drugs. Authored by four of the pharmaceutical industry's most respected scientists, this timely volume: Focuses on the processes that resulted in high-profile drugs including Lipitor, Celebrex, Viagra, Gleevec, Nexium, Claritin, and over a dozen others Provides an in-depth introduction to each drug, followed by a detailed account of its synthesis Organizes the drugs into fourteen therapeutic areas for clarity and ease of use Process chemists provide an essential bridge between chemistry and the marketplace, creating scientifically practical drug processes while never losing sight of the commercial viability of those processes. Contemporary Drug Synthesis meets the needs of a growing community of researchers in pharmaceutical research and development, and is both a useful guide for practicing pharmaceutical scientists and an excellent text for medicinal and organic chemistry students.

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