Chirality in Drug Design and Development

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Author :
Publisher : CRC Press
ISBN 13 : 0203021819
Total Pages : 1200 pages
Book Rating : 4.2/5 (3 download)

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Book Synopsis Chirality in Drug Design and Development by : Indra K. Reddy

Download or read book Chirality in Drug Design and Development written by Indra K. Reddy and published by CRC Press. This book was released on 2004-03-15 with total page 1200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characterist

Chiral Drugs

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1118075633
Total Pages : 469 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Chiral Drugs by : Guo-Qiang Lin

Download or read book Chiral Drugs written by Guo-Qiang Lin and published by John Wiley & Sons. This book was released on 2011-08-08 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: An integrated view of chiral drugs from concept and synthesisto pharmaceutical properties Chirality greatly influences a drug's biological and pharmacological properties. In an effort to achieve more predictable results from chiral drugs, the Food and Drug Administration now requires that these medicines be as pure as possible, which places great demands on drug synthesis, purification, analysis, and testing. To assist researchers in acquiring the essential knowledge to meet these rigid guidelines, Chiral Drugs focuses on three vital chiral technologies asymmetric synthesis, biocatalytic process, and chiral resolution to offer details on the basic concepts, key developments, and recent trends in chiral drug discovery, along with: The history of chiral drugs development and industrial applications of chiral technologies A section listing twenty-five approved or advanced-trial chiral drugs that lists each drug name, chemical name and properties, a representative synthetic pathway, pharmacological characterizations, and references An interdisciplinary approach combining synthetic organic chemistry, medicinal chemistry, and pharmacology Nearly two-thirds of the drugs on today's market are chiral drugs. Reducing and eliminating their negative characteristics is an ongoing and serious challenge for the pharmaceutical industry. With its well-balanced approach to covering each important aspect of chirality, Chiral Drugs champions important strategies for tipping the medical scale in a positive direction for the production of more effective and safer drugs.

Chirality in Drug Research

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527608710
Total Pages : 370 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Chirality in Drug Research by : Eric Francotte

Download or read book Chirality in Drug Research written by Eric Francotte and published by John Wiley & Sons. This book was released on 2007-09-24 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Divided into the three main sections of synthesis, analysis and drug development, this handbook covers all stages of the drug development process, including large-scale synthesis and purification of chirally pure pharmaceuticals. The two editors from academia and a major pharmaceutical company have assembled an experienced, international team who provide first-hand practical advice and report previously unpublished data. In the first section, the isolation of chiral drugs from natural sources, their production in enzymatic processes and the resolution of racemic mixtures in preparative chromatography are outlined in separate chapters. For the section on qualitative and quantitative analysis, enantioselective chromatographic methods are presented as well as optical methods and CE-MS, while the final section deals with the pharmacology, pharmacokinetics and metabolic aspects of chiral drugs, devoting whole chapters to stereoselective drug binding and modeling chiral drug-receptor interactions. With its unique industry-relevant aspects, this is a must for medicinal and pharmaceutical chemists.

Chirality in Drug Design and Synthesis

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Author :
Publisher : Academic Press
ISBN 13 : 1483288242
Total Pages : 264 pages
Book Rating : 4.4/5 (832 download)

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Book Synopsis Chirality in Drug Design and Synthesis by : C. Brown

Download or read book Chirality in Drug Design and Synthesis written by C. Brown and published by Academic Press. This book was released on 2013-10-22 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chirality in Drug Design and Synthesis is a collection of papers that discusses the property of asymmetry in the structural and synthetic chemistry of natural products, including the significance of chirality in medicinal chemistry. These papers examine the need for the preparation and study of pure enantiomers of chiral drug substances and their mechanism of interaction with enzymes and receptors. These papers also investigate the techniques in studying these interactions, as well as analyze the methods for their synthesis in enantiomerically pure form. One paper discusses the pharmacological and pharmacokinetic analyses made that point to the differences in the activity and disposition of enantiometric pairs. Another paper reviews the implications of the neglect of stereoselectivity at the different levels during the examination process of racemic drugs. Since no general guidelines exists for the development of drugs with chiral centers, one paper suggests a case-by-case approach in evaluating the safety and efficacy of drugs, particularly as regards how isomers differ in their effects. This collection is suitable for the pharmacologist, medicinal chemists, toxicologists, mechanistic chemists and synthetic organic chemists.

Chirality in Drug Design and Development

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Author :
Publisher : CRC Press
ISBN 13 : 9780203021811
Total Pages : 472 pages
Book Rating : 4.0/5 (218 download)

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Book Synopsis Chirality in Drug Design and Development by : Indra K. Reddy

Download or read book Chirality in Drug Design and Development written by Indra K. Reddy and published by CRC Press. This book was released on 2004-03-15 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characterist

Drug Discovery and Development

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Author :
Publisher : Springer Nature
ISBN 13 : 9811555346
Total Pages : 522 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Drug Discovery and Development by : Ramarao Poduri

Download or read book Drug Discovery and Development written by Ramarao Poduri and published by Springer Nature. This book was released on 2021-02-15 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the processes that are involved in the development of new drugs. The authors discuss the history, role of natural products and concept of receptor interactions with regard to the initial stages of drug discovery. In a single, highly readable volume, it outlines the basics of pharmacological screening, drug target identification, and genetics involved in early drug discovery. The final chapters introduce readers to stem therapeutics, pharmacokinetics, pharmacovigilance, and toxicological testing. Given its scope, the book will enable research scholars, professionals and young scientists to understand the key fundamentals of drug discovery, including stereochemistry, pharmacokinetics, clinical trials, statistics and toxicology.

Signposts to Chiral Drugs

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3034801254
Total Pages : 249 pages
Book Rating : 4.0/5 (348 download)

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Book Synopsis Signposts to Chiral Drugs by : Vitomir Sunjic

Download or read book Signposts to Chiral Drugs written by Vitomir Sunjic and published by Springer Science & Business Media. This book was released on 2011-05-10 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highlighting 15 selected chiral structures, which represent candidate or marketed drugs, and their chemical syntheses, the authors acquaint the reader with the fascinating achievements of synthetic and medicinal chemistry. The book starts with an introduction treating the discovery and development of a new drug entity. Each of the 15 subsequent chapters presents one of the target structures and begins with a description of its biological profile as well as any known molecular mechanisms of action, underlining the importance of its structural and stereochemical features. This section is followed by detailed discussions of synthetic approaches to the chiral target structure, highlighting creative ideas, the scaling-up of laboratory methods and their replacement by efficient modern technologies for large-scale production. Nearly 60 synthetic reactions, most of them stereoselective, catalytic or biocatalytic, as well as chiral separating methodologies are included in the book. Vitomir Sunjic and Michael J. Parnham provide an invaluable source of information for scientists in academia and the pharmaceutical industry who are actively engaged in the interdisciplinary development of new drugs, as well as for advanced students in chemistry and related fields.

Physico Chemical Methods in Drug Discovery and Development

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Author :
Publisher : IAPC Publishing
ISBN 13 : 9535694200
Total Pages : 500 pages
Book Rating : 4.5/5 (356 download)

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Book Synopsis Physico Chemical Methods in Drug Discovery and Development by : Zoran Mandic

Download or read book Physico Chemical Methods in Drug Discovery and Development written by Zoran Mandic and published by IAPC Publishing. This book was released on 2012 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Impact of Stereochemistry on Drug Development and Use

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Author :
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 736 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Impact of Stereochemistry on Drug Development and Use by : Hassan Y. Aboul-Enein

Download or read book The Impact of Stereochemistry on Drug Development and Use written by Hassan Y. Aboul-Enein and published by Wiley-Interscience. This book was released on 1997-04-11 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past fifteen years have seen a revolution in the field of stereochemistry, with breakthrough analytical techniques in enantiomeric separation profoundly affecting drug development and use. This practical reference written by leading researchers focuses on the important roles chirality and stereoisomerism play in drug development efforts--presenting for the first time a comprehensive overview of this rapidly evolving area of pharmacological research. The book explores analytical, pharmacological, and regulatory topics in dealing with the theory and practice of stereochemistry in the pharmaceutical industry today. This exciting, broad-appeal treatment extends from the analytical viewpoint in enantiomeric separation to the regulatory issues involved in the "racemate-versus-enantiomer" debate. The authors include numerous examples and case studies, and integrate material from a wide range of studies, publications, and workshops. The introductory chapters outline the pharmacological effects of stereochemistry, cover stereochemistry in drug metabolism, and discuss problems inherent in the duality of enantiomers--chemically identical yet spatially different molecules. Contributions on the specific aspects of chirality and drug activity explore the toxicological effects of stereoselectivity, illustrate how an understanding of the stereochemical composition of certain drugs can help avoid problems, and offer tips on new clinical applications for existing drugs. A full chapter is devoted to research opportunities in the development of new chirally pure drugs. Other practical research topics range from the preparation of chirally pure compounds to the analytical determination of stereochemical composition, to applications of circular dichroism (CD) spectroscopy. Regulatory issues concerning the development and approval of stereoisomeric drugs are discussed in the final chapters. This section offers an international perspective as well as a historical review of the ongoing debate surrounding regulatory guidelines. Impact of Stereochemistry on Drug Development and Use is an essential reference for medicinal and analytical chemists, pharmacologists, drug metabolism and pharmacokinetic scientists, and personnel of regulatory agencies. It is also a useful text for graduate students in stereochemistry, and for anyone who wants to keep up with the swift pace of change in this dynamic field. Impact of Stereochemistry on Drug Development and Use is an essential reference for medicinal and analytical chemists, pharmacologists, drug metabolism and pharmacokinetic scientists, and personnel of regulatory agencies. It is also a useful text for graduate students in stereochemistry, and for anyone who wants to keep up with the swift pace of change in this dynamic field. IMPACT OF STEREOCHEMISTRY ON DRUG DEVELOPMENT AND USE Twenty-three expert contributions on the "stereochemical revolution" of the last fifteen years--covering analytical, pharmacological, and regulatory topics--show that "drug development can no longer occur without consideration of drug stereochemistry." "We have...come full circle and stand alongside Pasteur in amazement of nature's duality, symmetry and dissymmetry, and its chemical and pharmacological consequences."--from the Preface

Chiral Drugs

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Author :
Publisher : Routledge
ISBN 13 : 1351808044
Total Pages : 1360 pages
Book Rating : 4.3/5 (518 download)

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Book Synopsis Chiral Drugs by : Cynthia A Challener

Download or read book Chiral Drugs written by Cynthia A Challener and published by Routledge. This book was released on 2017-10-23 with total page 1360 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title was first published in 2001: In the early twentieth century the relevance of chirality to the pharmaceutical industry was established by the fact that one enantiomer of hyoscyamine possessed greater pharmacological activity than the other. Today, most new drugs and those under development consist of a single optically active isomer, and chirality is also becoming an issue for the agrochemical and other industries. Regulatory agencies throughout the world are currently reviewing the importance of chirality with regard to pharmaceutical and agrochemical products. New guidelines from such agencies have been key drivers for the focus on single enantiomer products in these industries. These scientific and regulatory developments have created the need for a guide for workers in the pharmaceutical and chemical industries seeking information on chiral molecules, processes, and commercially available chiral chemicals. Chiral Drugs is a comprehensive listing of over 2500 chiral drugs, classified by therapeutic class, and including structures and physical properties for each entry in the listing. Its companion volume, Chiral Intermediates, presents the same detailed information for over 4700 commercially available chiral chemicals. The 'Chiral Pool' of readily available, relatively inexpensive chiral compounds has been expanding at a rapid rate as more and more products are produced in large quantities at economical prices. New developments in various technologies for isolating, preparing, and purifying chiral materials have greatly increased the opportunities for utilizing optically pure compounds in commercial applications. Novel techniques for classical resolution, new methodologies for developing selective enzymes for biocatalysis, advances in the application of microorganisms for chemical production, and continued progress in the area of asymmetric synthesis have all contributed to the growth of this field. Part One of each book contains four chapters which provide an introduction to topics relevant to the field of chiral chemistry and includes a brief overview of chirality, a short discussion on the current market drivers in the area of chiral chemistry, and a basic presentation of the various sources and methods for obtaining chiral compounds. Part Two presents entries for over 2500 chiral drugs, classified by therapeutic class. For each main entry, the chemical name and a list of trade names and synonyms is provided; the CAS Registry Number, the European Inventory of Existing Commercial Chemical Substances (EINECS) number, and the Merck Index (12th edition) number are given when available. The physical properties, including specific rotation, of each compound are described and indicated applications are presented. The structure of nearly every compound is provided, and the manufacturers and suppliers of the compounds are also given. Indexes, including a master index of names and synonyms and an index of custom manufacturing services for production of chiral compounds, are appended. Chiral Drugs provides an introduction to the types of sources and methods currently in use for obtaining chiral molecules and is an invaluable resource for researchers in the pharmaceutical and biotechnology sectors as well as to those working in the basic biochemical sciences. Chiral Intermediates provides an introduction to the types of sources and methods currently in use for obtaining chiral molecules and is an invaluable resource for information on available chiral molecules. Chiral Intermediates and Chiral Drugs are the most comprehensive and detailed guides to chiral compounds available.

Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 111953030X
Total Pages : 6057 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set by :

Download or read book Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set written by and published by John Wiley & Sons. This book was released on 2021-04-20 with total page 6057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.

Signposts to Chiral Drugs

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Author :
Publisher : Springer
ISBN 13 : 9783034801263
Total Pages : 232 pages
Book Rating : 4.8/5 (12 download)

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Book Synopsis Signposts to Chiral Drugs by : Vitomir Sunjic

Download or read book Signposts to Chiral Drugs written by Vitomir Sunjic and published by Springer. This book was released on 2013-01-02 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Highlighting 15 selected chiral structures, which represent candidate or marketed drugs, and their chemical syntheses, the authors acquaint the reader with the fascinating achievements of synthetic and medicinal chemistry. The book starts with an introduction treating the discovery and development of a new drug entity. Each of the 15 subsequent chapters presents one of the target structures and begins with a description of its biological profile as well as any known molecular mechanisms of action, underlining the importance of its structural and stereochemical features. This section is followed by detailed discussions of synthetic approaches to the chiral target structure, highlighting creative ideas, the scaling-up of laboratory methods and their replacement by efficient modern technologies for large-scale production. Nearly 60 synthetic reactions, most of them stereoselective, catalytic or biocatalytic, as well as chiral separating methodologies are included in the book. Vitomir Sunjic and Michael J. Parnham provide an invaluable source of information for scientists in academia and the pharmaceutical industry who are actively engaged in the interdisciplinary development of new drugs, as well as for advanced students in chemistry and related fields.

Drug Discovery and Development, Third Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1351625136
Total Pages : 860 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Drug Discovery and Development, Third Edition by : James J. O'Donnell

Download or read book Drug Discovery and Development, Third Edition written by James J. O'Donnell and published by CRC Press. This book was released on 2019-12-13 with total page 860 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business

Chiral Separations

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 1592596487
Total Pages : 427 pages
Book Rating : 4.5/5 (925 download)

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Book Synopsis Chiral Separations by : Gerald Gübitz

Download or read book Chiral Separations written by Gerald Gübitz and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prominent experts from around the world detail the chromatographic and electroseparation techniques they have developed for chiral separations on an analytical scale. Described in step-by-step detail to ensure successful experimental results, the procedures are presented as either general methods or as specific applications to substance classes and special compounds, with emphasis on high performance liquid chromatography and capillary electrophoresis techniques, but also including thin layer chromotographic, gas chromatographic, supercritical fluid chromatographic as well as recent electrochromotographic techniques.

Drug-like Properties: Concepts, Structure Design and Methods

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Author :
Publisher : Elsevier
ISBN 13 : 0080557619
Total Pages : 549 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Drug-like Properties: Concepts, Structure Design and Methods by : Li Di

Download or read book Drug-like Properties: Concepts, Structure Design and Methods written by Li Di and published by Elsevier. This book was released on 2010-07-26 with total page 549 pages. Available in PDF, EPUB and Kindle. Book excerpt: Of the thousands of novel compounds that a drug discovery project team invents and that bind to the therapeutic target, typically only a fraction of these have sufficient ADME/Tox properties to become a drug product. Understanding ADME/Tox is critical for all drug researchers, owing to its increasing importance in advancing high quality candidates to clinical studies and the processes of drug discovery. If the properties are weak, the candidate will have a high risk of failure or be less desirable as a drug product. This book is a tool and resource for scientists engaged in, or preparing for, the selection and optimization process. The authors describe how properties affect in vivo pharmacological activity and impact in vitro assays. Individual drug-like properties are discussed from a practical point of view, such as solubility, permeability and metabolic stability, with regard to fundamental understanding, applications of property data in drug discovery and examples of structural modifications that have achieved improved property performance. The authors also review various methods for the screening (high throughput), diagnosis (medium throughput) and in-depth (low throughput) analysis of drug properties. Serves as an essential working handbook aimed at scientists and students in medicinal chemistry Provides practical, step-by-step guidance on property fundamentals, effects, structure-property relationships, and structure modification strategies Discusses improvements in pharmacokinetics from a practical chemist's standpoint

Chiral Separation Techniques

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Author :
Publisher : Wiley-VCH
ISBN 13 :
Total Pages : 376 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Chiral Separation Techniques by : G. Subramanian

Download or read book Chiral Separation Techniques written by G. Subramanian and published by Wiley-VCH. This book was released on 2001 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a completely revised and updated sequel to 'A Practical Approach to Chiral Separations by Liquid Chromatography' by the same editor. The scope has been extended to further chiral separation techniques like electrophoresis, membrane separations, or biological assays. More emphasis is put on preparative separation techniques. From reviews of the previous edition: 'A team of experts from academic and industrial laboratories throughout the world have compiled their findings and experience to make this book an exceptionally timely and unique contribution to the field' European Journal of Drug Metabolism 'The dense mass of information contained in this book will make it a valuable resource ...' Chemical Engineering Research '... this is a worthwhile addition to the expanding chiral literature and the book should be of value to those working in this field' The Analyst

Drug Discovery and Development

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Author :
Publisher : BoD – Books on Demand
ISBN 13 : 1789239753
Total Pages : 166 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Drug Discovery and Development by : Vishwanath Gaitonde

Download or read book Drug Discovery and Development written by Vishwanath Gaitonde and published by BoD – Books on Demand. This book was released on 2020-03-11 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.