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Current Topics In Nonclinical Drug Development
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Book Synopsis Current Topics in Nonclinical Drug Development by : Pritam S. Sahota
Download or read book Current Topics in Nonclinical Drug Development written by Pritam S. Sahota and published by CRC Press. This book was released on 2023-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development"--
Book Synopsis Current Topics in Nonclinical Drug Development by : Pritam S. Sahota
Download or read book Current Topics in Nonclinical Drug Development written by Pritam S. Sahota and published by CRC Press. This book was released on 2020-12-23 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Book Synopsis Current Topics in Nonclinical Drug Development by : Philip Bentley
Download or read book Current Topics in Nonclinical Drug Development written by Philip Bentley and published by CRC Press. This book was released on 2023-11-03 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Assessing cardiovascular risks beyond QT interval. Use of 3D cell cultures in toxicology and ADME. Development of small molecule-antibody complexes. Differentiating adverse from non-adverse findings in nonclinical studies. Current Topics in Nonclinical Drug Development: Volume 2 will aid toxicologists, toxicologic pathologists, consultants, regulators, study directors, and nonclinical scientists dealing with day-to-day issues encountered in drug development and assist in formulating strategies for resolution of these issues. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Book Synopsis New Drug Development by : J. Rick Turner
Download or read book New Drug Development written by J. Rick Turner and published by John Wiley & Sons. This book was released on 2007-07-27 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Book Synopsis Current Topics in Nonclinical Drug Development by : Pritam S. Sahota
Download or read book Current Topics in Nonclinical Drug Development written by Pritam S. Sahota and published by CRC Press. This book was released on 2020-12-22 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. This first volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed. Additional features include: Deals with day-to-day issues in study design, evaluation of findings, and presentation of data. Explains new approaches in the development of medical devices. Includes dedicated chapters on the use of bioinformatics in drug development. Addresses strategies for photosafety testing of drugs. Current Topics in Nonclinical Drug Development, Volume I will aid toxicologists, toxicologic pathologists, consultants, regulators, Study Directors, and nonclinical scientists dealing with day-to-day issues in study design, evaluation of findings, and presentation of data. In addition, the book will be a valuable reference for academicians and graduate students pursuing research related to nonclinical drug development.
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Book Synopsis A Practical Guide to Drug Development in Academia by : Daria Mochly-Rosen
Download or read book A Practical Guide to Drug Development in Academia written by Daria Mochly-Rosen and published by Springer. This book was released on 2023-12-08 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review of first edition from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to start transforming their basic research discoveries into novel drugs. Often many potentially transformative basic science discoveries are not pursued because they are deemed 'too early' to attract industry interest. This comprehensive book lays out simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from discovery, optimization and preclinical studies through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. The SPARK model has been adopted in over 60 institutions on six continents, and the program has been honored with multiple awards including the 2020 Xconomy Award for Ecosystem Development, the 2020 Cures Within Reach Award for Patient Impact Research, and the 2022 California Life Sciences Pantheon Award for Academia, Non-Profits, & Research. The new edition updates every chapter with the latest developments since the 2014 publication of the first edition.
Book Synopsis Preclinical Drug Development by : Mark C. Rogge
Download or read book Preclinical Drug Development written by Mark C. Rogge and published by CRC Press. This book was released on 2005-08-16 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology through the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences.
Book Synopsis Preclinical Development Handbook by : Shayne Cox Gad
Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by Wiley-Interscience. This book was released on 2008-03-14 with total page 1080 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-11-02 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
Book Synopsis Advanced Issue Resolution in Safety Pharmacology by : Mary Jeanne Kallman
Download or read book Advanced Issue Resolution in Safety Pharmacology written by Mary Jeanne Kallman and published by Academic Press. This book was released on 2018-09-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.
Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley
Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.
Book Synopsis Preclinical Drug Development by : Mark Rogge
Download or read book Preclinical Drug Development written by Mark Rogge and published by CRC Press. This book was released on 2016-04-19 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula
Book Synopsis Pharmacokinetics in Drug Development by : Peter L. Bonate
Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2011-02-21 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams. They regard the practical considerations for assessment of selected special development populations. For example, they include characterization of drug disposition in pregnant subjects, for measuring arrhythmic potential, for analysis tumor growth modeling, and for disease progression modeling. Practical considerations for metabolite safety testing, transporter assessments, Phase 0 testing, and development and execution of drug interaction programs reflect current regulatory topics meant to address enhancement of both safety assessment and early decision-making during new candidate selection. Important technologies like whole body autoradiography, digital imaging and dried blood spot sample collection methods are introduced, as both have begun to take a more visible role in pharmacokinetic departments throughout the industry.
