Drug Drug Interactions

Author: A. David Rodrigues
Publisher: CRC Press
ISBN: 0429524307
Format: PDF, ePub
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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

A Comprehensive Guide to Toxicology in Preclinical Drug Development

Author: Ali S. Faqi
Publisher: Academic Press
ISBN: 0123878152
Format: PDF, Docs
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A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Introduction to the Pharmaceutical Sciences

Author: Nita K. Pandit
Publisher: Lippincott Williams & Wilkins
ISBN: 0781744784
Format: PDF, Docs
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This unique textbook provides an introductory, yet comprehensive overview of the pharmaceutical sciences. It is the first text of its kind to pursue an interdisciplinary approach in this area of study. Readers are introduced to basic concepts related to the specific disciplines in the pharmaceutical sciences, including pharmacology, pharmaceutics, pharmacokinetics, and medicinal chemistry. In an easy-to-read writing style, the book provides readers with up-to-date information on pharmacogenomics and includes comprehensive coverage of industrial drug development and regulatory approval processes. Each chapter includes chapter outlines and critical-thinking exercises, as well as numerous tables and graphs. More than 160 illustrations complement the text.

Drug Discovery and Evaluation Methods in Clinical Pharmacology

Author: H.Gerhard Vogel
Publisher: Springer Science & Business Media
ISBN: 3540898905
Format: PDF, Mobi
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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".

Drug Drug Interactions for Therapeutic Biologics

Author: Honghui Zhou
Publisher: John Wiley & Sons
ISBN: 1118630211
Format: PDF, ePub, Docs
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Strategize, plan, and execute comprehensive drug-druginteraction assessments for therapeutic biologics Offering both theory and practical guidance, this book fullyexplores drug-drug interaction assessments for therapeuticbiologics during the drug development process. It draws togetherand analyzes all the latest findings and practices in order topresent our current understanding of the topic and point the way tonew research. Case studies and examples, coupled with expertadvice, enable readers to better understand the complex mechanismsof biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics featurescontributions from leading international experts in all areas oftherapeutic biologics drug development and drug-drug interactions.The authors' contributions reflect a thorough review and analysisof the literature as well as their own firsthand laboratoryexperience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small moleculesand other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment andprediction Risk-based strategies for evaluating biologic drug-druginteractions Strategies to minimize drug-drug interaction risk and mitigatetoxic interactions Key regulations governing drug-drug interaction assessments fortherapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics isrecommended for pharmaceutical and biotechnology scientists,clinical pharmacologists, medicinal chemists, and toxicologists. Byenabling these readers to understand how therapeutic biologics mayinteract with other drugs, the book will help them develop safer,more effective therapeutic biologics.

Applications of Microdialysis in Pharmaceutical Science

Author: Tung-Hu Tsai
Publisher: John Wiley & Sons
ISBN: 9781118011287
Format: PDF, ePub, Docs
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Discover new and emerging applications for microdialysis in drug evaluation Microdialysis is a highly valuable sampling tool that can be used in vivo to measure free, unbound analyte concentrations located in interstitial and extracellular spaces. This book explores the full range of clinical applications for microdialysis, focusing on its use in different organ and tissue systems for pharmacokinetic and pharmacodynamic studies. Readers gain a full understanding of the underlying science of microdialysis, current techniques and practices, as well as its many applications in pharmaceutical research. Applications of Microdialysis in Pharmaceutical Science starts with an introduction to basic principles and then covers analytical considerations, pharmacodynamic and pharmacokinetic studies, clinical aspects, and special applications. Topics include: Role of microdialysis in drug development, including crucial sampling considerations and applications for nervous system diseases Continuous measurement of glucose concentrations in diabetics Applications for clinical evaluation and basic research on organ systems, including monitoring exogenous and endogenous compounds in the lungs Pharmacokinetic and pharmacodynamic evaluation of anticancer drugs Comparison of microdialysis with imaging approaches to evaluate in vivo drug distribution Special applications of microdialysis in studies of cell culture assays, drug-drug interactions, and environmental monitoring Throughout the book, readers will find simple models that clarify complex concepts and easy-to-follow examples that guide them through key applications in pharmaceutical research. In short, this book enables pharmaceutical researchers to take full advantage of microdialysis techniques for the preclinical and clinical evaluation of drugs and much more.

Enzyme and Transporter Based Drug Drug Interactions

Author: K. Sandy Pang
Publisher: Springer Science & Business Media
ISBN: 9781441908407
Format: PDF, Mobi
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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.

Psychotropic Drug Handbook

Author: Paul J. Perry
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781762731
Format: PDF, Kindle
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This succinct handbook provides students and practitioners with clinically relevant psychotropic drug information. The Eighth Edition is designed as a reference text that also teaches by delivering informative narrative text under standard headlines with references. Its focus goes beyond drug information to cover pharmacotherapy applications. The book provides detailed, well-referenced, evidence-based information on a wide range of psychotropic drugs, including mood stabilizers, antidepressants, and antianxiety agents. This edition has new chapters on pediatric and geriatric psychopharmacotherapy; new content on antipsychotics, hypnotics, medications used in treating alcoholism and substance dependence, and electroconvulsive therapy; and new algorithms, appendices, and tables.

Drug Drug Interactions Scientific and Regulatory Perspectives

Author:
Publisher: Academic Press
ISBN: 0080581358
Format: PDF, Docs
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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