Drug Drug Interactions Scientific And Regulatory Perspectives
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Drug-Drug Interactions: Scientific and Regulatory Perspectives by Anonim Pdf
Drug Drug Interactions is a comprehensive review of the scientific and regulatory perspectives of drug drug interactions from the point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry, health care, and governmental regulatory agencies. Topics of interest include the mechanistic understanding of drug drug interactions, the prediction of drug drug interaction potential of new drugs, and the avoidance of clinically significant drug drug interaction in patients. Provides useful references on the science of drug-drug interactions Describes in a basic and comprehensive manner drug-drug interactions from the mechanistic viewpoint Contains original data from academic and industrial laboratories Presents an overview of regulatory agency positions
Drug-Drug Interactions: Scientific and Regulatory Perspectives by Anonim Pdf
Drug–Drug Interactions is a comprehensive review of the scientific and regulatory perspectives of drug–drug interactions from the point-of-view of academia, industry, and government regulatory agencies. This book is intended for professionals in the pharmaceutical industry, health care, and governmental regulatory agencies. Topics of interest include the mechanistic understanding of drug–drug interactions, the prediction of drug–drug interaction potential of new drugs, and the avoidance of clinically significant drug–drug interaction in patients.
Author : Y. W. Francis Lam,Shiew-Mei Huang,Stephen D. Hall Publisher : CRC Press Page : 360 pages File Size : 51,8 Mb Release : 2006-06-07 Category : Medical ISBN : 0824725387
Herbal Supplements-Drug Interactions by Y. W. Francis Lam,Shiew-Mei Huang,Stephen D. Hall Pdf
The international popularity of herbal remedies has recently outpaced quality information on the utilization and dosing of these compounds. This book fills a void in the literature by offering an authoritative overview of the mechanisms of herbal remedies and their impact on standard medications. It offers a practical approach that focuses not only on specific drug interactions, but the mechanisms behind those interactions and their clinical significance. With contributions from leading experts on the subject, this text examines the overall use of herbs, includes sections on individual herbs, and considers pertinent regulatory issues and concerns in industry.
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives.Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on:key interplay between transporters and enzymes
Drug-Drug Interactions in Pharmaceutical Development by Binghe Wang Pdf
Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market. The book covers both clinical and nonclinical aspects for understanding drug-drug interactions as well as in vitro and in vivo studies for use in studying interactions at the drug discovery stage.
Author : K. Sandy Pang,A. David Rodrigues,Raimund M. Peter Publisher : Springer Science & Business Media Page : 746 pages File Size : 50,7 Mb Release : 2009-12-17 Category : Medical ISBN : 9781441908407
Enzyme- and Transporter-Based Drug-Drug Interactions by K. Sandy Pang,A. David Rodrigues,Raimund M. Peter Pdf
Germination of the thought of "Enzymatic- and Transporter-Based Drug-Drug Interactions: Progress and Future Challenges" Proceedings came about as part of the annual meeting of The American Association of Pharmaceutical Scientists (AAPS) that was held in San Diego in November of 2007. The attendance of workshop by more than 250 pharmaceutical scientists reflected the increased interest in the area of drug-drug interactions (DDIs), the greater focus of PhRMA, academia, and regulatory agencies, and the rapid pace of growth in knowledge. One of the aims of the workshop was to address the progress made in quantitatively predicting enzyme- and transporter-based DDIs as well as highlighted areas where such predictions are poor or areas that remain challenging for the future. Because of the serious clinical implications, initiatives have arisen from the FDA (http://www.fda.gov/cber/gdlns/interactstud.htm) to highlight the importance of enzyme- and transporter-based DDIs. During the past ten to fifteen years, we have come to realize that transporters, in addition to enzymes, play a vital role in drug elimination. Such insight has been possible because of the continued growth in PK-ADME (pharmacokinetics-absorption-distribution-metabolism-excretion) knowledge, fueled by further advances in molecular biology, greater availability of human tissues, and the development of additional and sophisticated model systems and sensitive assay methods for studying drug metabolism and transport in vitro and in vivo. This has sparked an in-depth probing into mechanisms surrounding DDIs, resulting from ligand-induced changes in nuclear receptors, as well as alterations in transporter and enzyme expression and function. Despite such advances, the in vitro and in vivo study of drug interactions and the integration of various data sets remain challenging. Therefore, it has become apparent that a proceeding that serves to encapsulate current strategies, approaches, methods and applications is necessary. As Editors, we have assembled a number of opinion leaders and asked them to contribute chapters surrounding these issues. Many of these are the original Workshop speakers whereas others had been selected specially to contribute on topics related to basic and applied information that had not been covered in other reference texts on DDI. The resulting tome, entitled Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges, comprises of four sections. Twenty-eight chapters covering various topics and perspectives related to the subject of metabolic and transporter-based drug-drug interactions are presented.
Authored by renowned leaders in the field, this comprehensive volume covers all aspects of drug-drug interactions, including preclinical, clinical, toxicological, and regulatory perspectives. Thoroughly updated, this second edition reflects the significant advances and includes extensive new material on: key interplay between transporters and enzymes in drug metabolism and drug interactions the integral role of pharmacogenetics in metabolism-based drug-drug interactions in vivo - in vitro correlations (reversible, mechanism-based inhibition, induction) in silico approaches enabling structure-activity and structure-function studies high-throughput screening and GLP methods for evaluating drug interactions in vitro the use of transgenic animal models to evaluate drug interactions Providing helpful case examples and computer-aided modeling, Drug-Drug Interactions is filled with over 200 invaluable tables, equations, and figures to clarify key concepts, and incorporates critical new updated information.
Encyclopedia of Drug Metabolism and Interactions, Clinical Aspects by Anonim Pdf
The ideal place to begin researching any question involving drug metabolism and interactions The Encyclopedia of Drug Metabolism and Interactions provides essential support during all phases of drug development, from drug design to drug action and interaction within the human body. This six-volume work covers both preclinical and clinical aspects of drug metabolism and interactions. It also provides a wealth of toxicological, regulatory, and marketing information, all written and edited by leading international experts in the field. By collecting and reviewing the current literature in the field in one expertly organized work, this encyclopedia is the ideal place to begin researching any question involving drug metabolism and interactions. Readers will find such important topics and working tools as: Inhibited or induced enzymes and their impact on drug toxicity and altered response in both animal and human models Effects of both genetic and non-genetic factors on drug metabolism Relationships between a drug metabolism, its activation or inactivation, and a drug's potential toxicity/safety Examples demonstrating all aspects of drug metabolism and interactions in silico, in vitro, in laboratory animals, and in humans Methods and protocols enabling readers to perform seamless studies of metabolism and drug interactions All articles are based on recent findings and standards of practice. By reviewing and contextualizing the current literature, the authors offer new perspectives on our current state of knowledge as well as future directions for research in drug metabolism and interactions. References at the end of each article serve as a gateway to the literature. The Encyclopedia of Drug Metabolism and Interactions is recommended for researchers, physicians, and students at all levels. It introduces the basics to novices and explores the latest science and applications for more experienced investigators.
Pharmacogenomics by Yui-Wing Francis Lam,Larisa H. Cavallari Pdf
Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation includes discussions and viewpoints from the academic, regulatory, pharmaceutical, clinical, socio-ethical and economic perspectives. Each chapter presents an overview of the potential or opportunity within the areas discussed and also outlines foreseeable challenges and limitations in moving pharmacogenomics into drug development and direct therapeutic applications. This edited book contains review questions for a more in-depth analysis of the implications of pharmacogenomics and discussion points to generate ideas on best to move the field forward. Clinical pearls and case studies are used to illustrate real-life experiences and both successful and unsuccessful applications. Tables, figures, and annotations are included throughout the book to facilitate understanding and further reference. Multi-contributed book and chapters are written by contributors who are experts in their field Provides perspectives from those involved in all aspects of pharmacogenomics—including academic, regulatory, economic, industry and medical—to illustrate how all of the pieces fit together and where the challenges may be Includes case studies of both successful and unsuccessful applications so readers can consider the potential and challenges in moving the science into drug development and direct therapeutic applications Chapters contain discussion questions and clinical pearls and enable readers to reflect on how to move pharmacogenomics forward and apply these observations and useful tips to their own work and research
Encyclopedia of Drug Metabolism and Interactions, Clinical Aspects by Anonim Pdf
"This multi-volume encyclopedia discusses all preclinical, clinical, toxicological, regulatory and marketing perspectives of drug metabolism and interactions. The various types of enzymes that can be inhibited or induced and their impact on drug toxicity and altered response are covered both for animal models and humans"--Provided by publisher.
Pharmacogenomics by Yui-Wing Francis Lam,Larisa H. Cavallari Pdf
Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation includes discussions and viewpoints from the academic, regulatory, pharmaceutical, clinical, socio-ethical and economic perspectives. Each chapter presents an overview of the potential or opportunity within the areas discussed and also outlines foreseeable challenges and limitations in moving pharmacogenomics into drug development and direct therapeutic applications. This edited book contains review questions for a more in-depth analysis of the implications of pharmacogenomics and discussion points to generate ideas on best to move the field forward. Clinical pearls and case studies are used to illustrate real-life experiences and both successful and unsuccessful applications. Tables, figures, and annotations are included throughout the book to facilitate understanding and further reference.
Encyclopedia of Drug Metabolism and Interactions by Alexander Lyubimov Pdf
This multi-volume, state-of-the-art encyclopedia discusses all preclinical, clinical, toxicological, regulatory and marketing perspectives of drug metabolism and interactions. Methods and detailed protocols describing how to perform studies of metabolism and drug interactions are presented in one of the volumes. All aspects of drug metabolism and interactions in silico, in laboratory animals and in humans, are backed with a range of examples. This reference is essential for researchers interested in all aspects of drug development, and chemists, pharmacologists, pharmaceutical specialists, toxicologists, molecular toxicologists, and clinicians including practitioners and physicians.
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 : 118 pages File Size : 50,6 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.
Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards
Author : Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards Publisher : John Wiley & Sons Page : 738 pages File Size : 47,8 Mb Release : 2001-11-28 Category : Medical ISBN : 0471899275
Drug Benefits and Risks by Chris J. van Boxtel,Budiono Santoso,I. Ralph Edwards Pdf
This is an inclusive reference exploring the scientific basis and practice of drug therapy. The key concept is to look at the balance between the benefits and risks of drugs but in this context also the social impact which drugs have in modern societies is highlighted. Taking an evidence-based approach to the problem, the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world is examined. For this purpose the book * Covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases * Gives guidance on how doctors should act so that drugs can be used effectively and safely * Encourages the rational use of drugs in society This book brings together a large amount of excellent content that will be invaluable for anyone working within, or associated with, the field of clinical pharmacology and pharmacotherapy - undergraduates, postgraduates, regulatory authorities and the pharmaceutical industry.
Drug Discovery and Evaluation: Methods in Clinical Pharmacology by H.Gerhard Vogel,Jochen Maas,Alexander Gebauer Pdf
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
