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Author : Pritam S. Sahota,P. Bentley,Zbigniew W. Wojcinski Publisher : Current Topics in Nonclinical Drug Development Series Page : 0 pages File Size : 54,9 Mb Release : 2023-10 Category : Drug development ISBN : 0367466686
Current Topics in Nonclinical Drug Development by Pritam S. Sahota,P. Bentley,Zbigniew W. Wojcinski Pdf
Written by a variety of experts in the field, this book explores the critical issues and current topics in nonclinical drug development. It covers individual topics and strategies in drug development from compound characterization to drug registration.
Current Topics in Nonclinical Drug Development by Philip Bentley,Pritam S. Sahota,Zbigniew Wojcinski Pdf
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.
Current Topics in Nonclinical Drug Development by Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski Pdf
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.
Current Topics in Nonclinical Drug Development by Pritam S. Sahota,Philip Bentley,Zbigniew Wojcinski Pdf
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.
Author : J. Rick Turner Publisher : Springer Science & Business Media Page : 269 pages File Size : 49,7 Mb Release : 2010-07-16 Category : Medical ISBN : 9781441964182
New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.
Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 107 pages File Size : 53,5 Mb Release : 2014-02-06 Category : Medical ISBN : 9780309292498
Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
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.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Publisher : National Academies Press Page : 442 pages File Size : 52,8 Mb Release : 2011-04-03 Category : Medical ISBN : 9780309158060
Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf
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.
A Comprehensive Guide to Toxicology in Preclinical Drug Development by Ali S. Faqi Pdf
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 --
Toxicologic Pathology by Pritam S. Sahota,Robert H. Spaet,Zbigniew W. Wojcinski Pdf
There has been an enormous growth of interest in the field of toxicologic pathology and particularly on its impact on nonclinical safety assessment in global drug development and in the environment. Toxicologic pathologists play an important role in detecting test article-related adverse effects by characterizing morphologic changes in animal tissues and/or body fluids under prescribed study conditions or less clearly defined conditions in the environment and in the interpretation of these findings relative to human risk. In fact, pathology evaluation is often the single most important decision-making factor in nonclinical safety assessments as 80% of drug candidate attrition has been attributed to pathology findings in toxicity studies. There are currently no primers or basic overviews covering the field of toxicologic pathology, whereas there are at least several basic books that cover the sister field of toxicology. Toxicologic Pathology: A Primer is a practical, easy-to-use reference designed to contain core information provided by board-certified veterinary pathologists, all experts in the field. The Primer contains the basic, underlying principles of toxicologic pathology at the introductory level; thus it will be valuable to the veterinary pathology student who may be considering a career in the field as well as a companion to the seasoned toxicologic pathologist who wants a succinct refresher. The Primer is arranged as chapters presenting each major organ system preceded by an overview chapter covering the field of toxicologic pathology followed by a “concept” chapter describing the role of toxicologic pathology in drug development. Photomicrographs and illustrations provide visual context. The organ system chapters provide histopathologic descriptions of lesions observed in toxicity studies of test articles in drug development and testing of chemicals that may negatively impact the environment. Each organ system chapter provides additional information related to a particular lesion to aid the reader in better understanding its toxicologic significance relative to human risk. Each organ system chapter contains: A brief introduction A succinct description of the anatomy and physiology of the system Descriptions of the most important pathological lesions Differential diagnoses Biological consequences, pathogenesis, and/or mechanism of lesion formation Associated clinical pathology correlates Nonclinical safety scientists such as study directors, non-pathology-oriented contributing scientists such as senior toxicology report reviewers, scientific management of Contract Research Organizations (CROs), and students should find the Primer useful in helping them understand the fundamentals of toxicologic pathology.
Advanced Issue Resolution in Safety Pharmacology by Mary Jeanne Kallman,Michael Pugsley Pdf
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.
National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services Publisher : National Academies Press Page : 103 pages File Size : 49,5 Mb Release : 2020-01-27 Category : Medical ISBN : 9780309498517
The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services Pdf
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.
Preclinical Drug Development by Mark Rogge,David R. Taft Pdf
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
Clinical Pharmacology: Current Topics and Case Studies by Markus Müller Pdf
This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry.
Atkinson's Principles of Clinical Pharmacology by Shiew-Mei Huang,Juan J.L. Lertora,Paolo Vicini,Arthur J. Atkinson Jr. Pdf
Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK
