Drug Safety Evaluation

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Publisher : John Wiley & Sons
ISBN 13 : 1119097401
Total Pages : 918 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Evaluation of Enzyme Inhibitors in Drug Discovery

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Publisher : John Wiley & Sons
ISBN 13 : 111854028X
Total Pages : 588 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Evaluation of Enzyme Inhibitors in Drug Discovery by : Robert A. Copeland

Download or read book Evaluation of Enzyme Inhibitors in Drug Discovery written by Robert A. Copeland and published by John Wiley & Sons. This book was released on 2013-01-31 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers essential guidance for discovering and optimizing novel drug therapies Using detailed examples, Evaluation of Enzyme Inhibitors in Drug Discovery equips researchers with the tools needed to apply the science of enzymology and biochemistry to the discovery, optimization, and preclinical development of drugs that work by inhibiting specific enzyme targets. Readers will applaud this book for its clear and practical presentations, including its expert advice on best practices to follow and pitfalls to avoid. This Second Edition brings the book thoroughly up to date with the latest research findings and practices. Updates explore additional forms of enzyme inhibition and special treatments for enzymes that act on macromolecular substrates. Readers will also find new discussions detailing the development and application of the concept of drug-target residence time. Evaluation of Enzyme Inhibitors in Drug Discovery begins by explaining why enzymes are such important drug targets and then examines enzyme reaction mechanisms. The book covers: Reversible modes of inhibitor interactions with enzymes Assay considerations for compound library screening Lead optimization and structure-activity relationships for reversible inhibitors Slow binding and tight binding inhibitors Drug-target residence time Irreversible enzyme inactivators The book ends with a new chapter exploring the application of quantitative biochemical principles to the pharmacologic evaluation of drug candidates during lead optimization and preclinical development. The Second Edition of Evaluation of Enzyme Inhibitors in Drug Discovery continues to offer a treatment of enzymology applied to drug discovery that is quantitative and mathematically rigorous. At the same time, the clear and simple presentations demystify the complex science of enzymology, making the book accessible to many fields— from pharmacology to medicinal chemistry to biophysics to clinical medicine.

Drug-Induced Liver Injury

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Author :
Publisher : Academic Press
ISBN 13 : 0128173173
Total Pages : 288 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Drug-Induced Liver Injury by :

Download or read book Drug-Induced Liver Injury written by and published by Academic Press. This book was released on 2019-07-13 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug-Induced Liver Injury, Volume 85, the newest volume in the Advances in Pharmacology series, presents a variety of chapters from the best authors in the field. Chapters in this new release include Cell death mechanisms in DILI, Mitochondria in DILI, Primary hepatocytes and their cultures for the testing of drug-induced liver injury, MetaHeps an alternate approach to identify IDILI, Autophagy and DILI, Biomarkers and DILI, Regeneration and DILI, Drug-induced liver injury in obesity and nonalcoholic fatty liver disease, Mechanisms of Idiosyncratic Drug-Induced Liver Injury, the Evaluation and Treatment of Acetaminophen Toxicity, and much more. Includes the authority and expertise of leading contributors in pharmacology Presents the latest release in the Advances in Pharmacology series

Principles of Research Design and Drug Literature Evaluation

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Publisher : Jones & Bartlett Publishers
ISBN 13 : 1449691315
Total Pages : 400 pages
Book Rating : 4.4/5 (496 download)

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Book Synopsis Principles of Research Design and Drug Literature Evaluation by : Rajender R. Aparasu

Download or read book Principles of Research Design and Drug Literature Evaluation written by Rajender R. Aparasu and published by Jones & Bartlett Publishers. This book was released on 2014-03-07 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Research Design and Drug Literature Evaluation is a unique resource that provides a balanced approach covering critical elements of clinical research, biostatistical principles, and scientific literature evaluation techniques for evidence-based medicine. This accessible text provides comprehensive course content that meets and exceeds the curriculum standards set by the Accreditation Council for Pharmacy Education (ACPE). Written by expert authors specializing in pharmacy practice and research, this valuable text will provide pharmacy students and practitioners with a thorough understanding of the principles and practices of drug literature evaluation with a strong grounding in research and biostatistical principles. Principles of Research Design and Drug Literature Evaluation is an ideal foundation for professional pharmacy students and a key resource for pharmacy residents, research fellows, practitioners, and clinical researchers. FEATURES * Chapter Pedagogy: Learning Objectives, Review Questions, References, and Online Resources * Instructor Resources: PowerPoint Presentations, Test Bank, and an Answer Key * Student Resources: a Navigate Companion Website, including Crossword Puzzles, Interactive Flash Cards, Interactive Glossary, Matching Questions, and Web Links From the Foreword: "This book was designed to provide and encourage practitioner’s development and use of critical drug information evaluation skills through a deeper understanding of the foundational principles of study design and statistical methods. Because guidance on how a study’s limited findings should not be used is rare, practitioners must understand and evaluate for themselves the veracity and implications of the inherently limited primary literature findings they use as sources of drug information to make evidence-based decisions together with their patients. The editors organized the book into three supporting sections to meet their pedagogical goals and address practitioners’ needs in translating research into practice. Thanks to the editors, authors, and content of this book, you can now be more prepared than ever before for translating research into practice." L. Douglas Ried, PhD, FAPhA Editor-in-Chief Emeritus, Journal of the American Pharmacists Association Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Texas at Tyler, Tyler, Texas

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Author :
Publisher : Springer
ISBN 13 : 9783642252396
Total Pages : 0 pages
Book Rating : 4.2/5 (523 download)

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Book Synopsis Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by : H. Gerhard Vogel

Download or read book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2013-02-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: -A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Drug Abuse Treatment Evaluation

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Publisher :
ISBN 13 :
Total Pages : 194 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Drug Abuse Treatment Evaluation by : National Institute on Drug Abuse

Download or read book Drug Abuse Treatment Evaluation written by National Institute on Drug Abuse and published by . This book was released on 1984 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Evaluation of Enzyme Inhibitors in Drug Discovery

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 0471723266
Total Pages : 295 pages
Book Rating : 4.4/5 (717 download)

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Book Synopsis Evaluation of Enzyme Inhibitors in Drug Discovery by : Robert A. Copeland

Download or read book Evaluation of Enzyme Inhibitors in Drug Discovery written by Robert A. Copeland and published by John Wiley & Sons. This book was released on 2005-04-01 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vital information for discovering and optimizing new drugs "Understanding the data and the experimental details that support it has always been at the heart of good science and the assumption challenging process that leads from good science to drug discovery. This book helps medicinal chemists and pharmacologists to do exactly that in the realm of enzyme inhibitors." -Paul S. Anderson, PhD This publication provides readers with a thorough understanding of enzyme-inhibitor evaluation to assist them in their efforts to discover and optimize novel drug therapies. Key topics such as competitive, noncompetitive, and uncompetitive inhibition, slow binding, tight binding, and the use of Hill coefficients to study reaction stoichiometry are all presented. Examples of key concepts are presented with an emphasis on clinical relevance and practical applications. Targeted to medicinal chemists and pharmacologists, Evaluation of Enzyme Inhibitors in Drug Discovery focuses on the questions that they need to address: * What opportunities for inhibitor interactions with enzyme targets arise from consideration of the catalytic reaction mechanism? * How are inhibitors evaluated for potency, selectivity, and mode of action? * What are the advantages and disadvantages of specific inhibition modalities with respect to efficacy in vivo? * What information do medicinal chemists and pharmacologists need from their biochemistry and enzymology colleagues to effectively pursue lead optimization? Beginning with a discussion of the advantages of enzymes as targets for drug discovery, the publication then explores the reaction mechanisms of enzyme catalysis and the types of interactions that can occur between enzymes and inhibitory molecules that lend themselves to therapeutic use. Next are discussions of mechanistic issues that must be considered when designing enzyme assays for compound library screening and for lead optimization efforts. Finally, the publication delves into special forms of inhibition that are commonly encountered in drug discovery efforts, but can be easily overlooked or misinterpreted. This publication is designed to provide students with a solid foundation in enzymology and its role in drug discovery. Medicinal chemists and pharmacologists can refer to individual chapters as specific issues arise during the course of their ongoing drug discovery efforts.

Drug Safety Evaluation

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119097398
Total Pages : 914 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad

Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-07 with total page 914 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Author :
Publisher : Springer
ISBN 13 : 9783540334422
Total Pages : 889 pages
Book Rating : 4.3/5 (344 download)

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Book Synopsis Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by : H. Gerhard Vogel

Download or read book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays written by H. Gerhard Vogel and published by Springer. This book was released on 2006-09-21 with total page 889 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs. The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process. In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.

Drug Discovery and Evaluation: Pharmacological Assays

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Publisher : Springer
ISBN 13 : 9783319053912
Total Pages : 0 pages
Book Rating : 4.0/5 (539 download)

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Book Synopsis Drug Discovery and Evaluation: Pharmacological Assays by : Franz J. Hock

Download or read book Drug Discovery and Evaluation: Pharmacological Assays written by Franz J. Hock and published by Springer. This book was released on 2015-11-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 4th edition of this successful reference book contains an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Effects covered include cardiovascular, analgesic, endocrine, psychotropic, respiratory, renal and immunomodulatory activities. Each of the more than 1,000 assays comprises a detailed protocol outlining the purpose and rationale of the method, a critical assessment of the results and their pharmacological and clinical relevance. In addition, animal models of rare diseases are described. For this 4th edition, all existing chapters have been revised and completely updated. A large number of assays were added. Sections that have been specifically enlarged include - Pharmacological assays in thrombosis and haemostasis, - Antidiabetic activity (includes completely new chapters such as Biochemical Methods in Diabetology), - Anti-atherosclerotic activity. New chapters are added such as Auditory Pharmacology, Oncology Activity, Stem Cells, Omics, Personalized Medicine, etc.

Drug Discovery and Evaluation: Pharmacological Assays

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Publisher : Springer Science & Business Media
ISBN 13 : 3540714200
Total Pages : 2118 pages
Book Rating : 4.5/5 (47 download)

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Book Synopsis Drug Discovery and Evaluation: Pharmacological Assays by : Hans Vogel

Download or read book Drug Discovery and Evaluation: Pharmacological Assays written by Hans Vogel and published by Springer Science & Business Media. This book was released on 2007-10-30 with total page 2118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new edition of this successful reference offers both cutting-edge and classic pharmacological methods. Thoroughly revised and expanded to two volumes, it offers an updated selection of the most frequently used assays for reliably detecting the pharmacological effects of potential drugs. Every chapter has been updated, and numerous assays have been added. Each of the more than 1,000 assays comprises a detailed protocol outlining purpose and rationale, and a critical assessment of the results and their pharmacological and clinical relevance.

General Considerations for the Clinical Evaluation of Drugs

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Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis General Considerations for the Clinical Evaluation of Drugs by : United States. Food and Drug Administration. Bureau of Drugs

Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Approved Drug Products with Therapeutic Equivalence Evaluations

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Publisher :
ISBN 13 :
Total Pages : 72 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Approved Drug Products with Therapeutic Equivalence Evaluations by :

Download or read book Approved Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 2005 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 30th Edition (2010)

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Author :
Publisher : DrugPatentWatch.com
ISBN 13 : 1934899801
Total Pages : 1115 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 30th Edition (2010) by : Food and Drug Administration

Download or read book Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 30th Edition (2010) written by Food and Drug Administration and published by DrugPatentWatch.com. This book was released on 2010 with total page 1115 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Orange Book 30th Edition - 2010 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Approved Drug Products With Therapeutic Equivalance Evaluations - FDA Orange Book 27th Edition (2007)

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Author :
Publisher : DrugPatentWatch.com
ISBN 13 : 1934899771
Total Pages : 1070 pages
Book Rating : 4.9/5 (348 download)

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Book Synopsis Approved Drug Products With Therapeutic Equivalance Evaluations - FDA Orange Book 27th Edition (2007) by : Food and Drug Administration

Download or read book Approved Drug Products With Therapeutic Equivalance Evaluations - FDA Orange Book 27th Edition (2007) written by Food and Drug Administration and published by DrugPatentWatch.com. This book was released on 2007 with total page 1070 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Orange Book 27th Edition - 2007 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Approved Prescription Drug Products with Therapeutic Equivalence Evaluations

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Publisher :
ISBN 13 :
Total Pages : 294 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Approved Prescription Drug Products with Therapeutic Equivalence Evaluations by :

Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on 1982 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.

Field Evaluation of the Los Angeles Police Department Drug Detection Program. Technical Report

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Publisher :
ISBN 13 :
Total Pages : 58 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Field Evaluation of the Los Angeles Police Department Drug Detection Program. Technical Report by : Richard P. Compton

Download or read book Field Evaluation of the Los Angeles Police Department Drug Detection Program. Technical Report written by Richard P. Compton and published by . This book was released on 1986 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: