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Author : Jochen Kuhlmann
Publisher : W. Zuckschwerdt
ISBN 13 : 9783886035199
Total Pages : 73 pages
Book Rating : 4.0/5 (351 download)
Download or read book Drug Interaction Studies During Drug Development written by Jochen Kuhlmann and published by W. Zuckschwerdt. This book was released on 1994-01-01 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Honghui Zhou
Publisher : John Wiley & Sons
ISBN 13 : 1118630211
Total Pages : 272 pages
Book Rating : 4.1/5 (186 download)
Download or read book Drug-Drug Interactions for Therapeutic Biologics written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2013-05-10 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.
Author : Binghe Wang
Publisher : John Wiley & Sons
ISBN 13 : 9786612022067
Total Pages : 244 pages
Book Rating : 4.0/5 (22 download)
Download or read book Drug-drug Interactions in Pharmaceutical Development written by Binghe Wang and published by John Wiley & Sons. This book was released on 2008-03-05 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Binghe Wang
Publisher : John Wiley & Sons
ISBN 13 : 0470187913
Total Pages : 261 pages
Book Rating : 4.4/5 (71 download)
Download or read book Drug-Drug Interactions in Pharmaceutical Development written by Binghe Wang and published by John Wiley & Sons. This book was released on 2008-03-05 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Donglu Zhang
Publisher : John Wiley & Sons
ISBN 13 : 9780470191682
Total Pages : 448 pages
Book Rating : 4.1/5 (916 download)
Download or read book Drug Metabolism in Drug Design and Development written by Donglu Zhang and published by John Wiley & Sons. This book was released on 2007-11-16 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The essentials of drug metabolism vital to developing new therapeutic entities Information on the metabolism and disposition of candidate drugs is a critical part of all aspects of the drug discovery and development process. Drug metabolism, as practiced in the pharmaceutical industry today, is a complex, multidisciplinary field that requires knowledge of sophisticated analytical technologies and expertise in mechanistic and kinetic enzymology, organic reaction mechanism, pharmacokinetic analysis, animal physiology, basic chemical toxicology, preclinical pharmacology, and molecular biology. With chapters contributed by experts in their specific areas, this reference covers: * Basic concepts of drug metabolism * The role of drug metabolism in the pharmaceutical industry * Analytical techniques in drug metabolism * Common experimental approaches and protocols Drug Metabolism in Drug Design and Development emphasizes practical considerations such as the data needed, the experiments and analytical methods typically employed, and the interpretation and application of data. Chapters highlight facts, common protocols, detailed experimental designs, applications, and limitations of techniques. This is a comprehensive, hands-on reference for drug metabolism researchers as well as other professionals involved in pre-clinical drug discovery and development.
Author : Binghe Wang
Publisher : John Wiley & Sons
ISBN 13 : 0471794414
Total Pages : 276 pages
Book Rating : 4.4/5 (717 download)
Download or read book Drug-Drug Interactions in Pharmaceutical Development written by Binghe Wang and published by John Wiley & Sons. This book was released on 2007-11-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Markus Müller
Publisher : Springer Science & Business Media
ISBN 13 : 3709101441
Total Pages : 438 pages
Book Rating : 4.7/5 (91 download)
Download or read book Clinical Pharmacology: Current Topics and Case Studies written by Markus Müller and published by Springer Science & Business Media. This book was released on 2011-02-04 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP.
Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 1441992162
Total Pages : 556 pages
Book Rating : 4.4/5 (419 download)
Download or read book Applications of Pharmacokinetic Principles in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.
Author : Manjunath P. Pai
Publisher : Springer
ISBN 13 : 3319724223
Total Pages : 336 pages
Book Rating : 4.3/5 (197 download)
Download or read book Drug Interactions in Infectious Diseases: Mechanisms and Models of Drug Interactions written by Manjunath P. Pai and published by Springer. This book was released on 2018-03-05 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 4th edition of Drug Interactions in Infectious Diseases is being split into two separate volumes – “Mechanisms and Models of Drug Interactions” and “Antimicrobial Drug Interactions”. This volume, “Mechanisms and Models of Drug Interactions,” delivers a text that enhances clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The book provides a comprehensive review of basic clinical pharmacology with a focus on metabolism and transporter-mediated drug interactions. The chapters address materials that cannot be retrieved easily in the medical literature, including materials focused on the complex interrelationship of acute infection, inflammation, and the risk of drug interactions in the Drug-Cytokine chapter. The Food-Drug and Herb-Drug interactions chapters remain definitive resources. A new chapter on in vitro modeling of drug interactions is included along with updates on design and data analysis of clinical drug interaction studies. Authoritative discussion of models for regulatory decision-making on drug-drug interactions provides the necessary framework to aid antimicrobial drug development. This concise review of the mechanisms and models of drug interactions provides important insights to health care practitioners as well as scientists in drug development.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)
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.
Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 236 pages
Book Rating : 4.5/5 (876 download)
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author : Brian L. Strom
Publisher : John Wiley & Sons
ISBN 13 : 1119413419
Total Pages : 1220 pages
Book Rating : 4.1/5 (194 download)
Download or read book Pharmacoepidemiology written by Brian L. Strom and published by John Wiley & Sons. This book was released on 2019-12-16 with total page 1220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Author : A. Yacobi
Publisher : Springer Science & Business Media
ISBN 13 : 147571520X
Total Pages : 266 pages
Book Rating : 4.4/5 (757 download)
Download or read book Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development written by A. Yacobi and published by Springer Science & Business Media. This book was released on 2013-11-11 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proceedings of a conference sponsored by the American Association of Pharmaceutical Scientists, the U.S. Food and Drug Administration, and the American Society for Clinical Pharmacology and Therapeutics, held in Arlington, Virginia, April 24-26, 1991
Author : A. David Rodrigues
Publisher : CRC Press
ISBN 13 : 0849375940
Total Pages : 769 pages
Book Rating : 4.8/5 (493 download)
Download or read book Drug-Drug Interactions written by A. David Rodrigues and published by CRC Press. This book was released on 2019-01-03 with total page 769 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Yuichi Sugiyama
Publisher : Springer Science & Business Media
ISBN 13 : 1461482291
Total Pages : 322 pages
Book Rating : 4.4/5 (614 download)
Download or read book Transporters in Drug Development written by Yuichi Sugiyama and published by Springer Science & Business Media. This book was released on 2013-09-16 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transporters in Drug Development examines how membrane transporters can be dealt with in academic–industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters’ impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are explored, and the book highlights perspectives of applying targeted proteomics and mechanistic modeling in this process.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030917452X
Total Pages : 56 pages
Book Rating : 4.3/5 (91 download)
Download or read book Pharmacokinetics and Drug Interactions in the Elderly and Special Issues in Elderly African-American Populations written by Institute of Medicine and published by National Academies Press. This book was released on 1997-08-25 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reports in the popular press about the increasing longevity of Americans and the aging of the baby boom generation are constant reminders that the American population is becoming older. Consequently, an issue of growing medical, health policy, and social concern is the appropriate and rational use of medications by the elderly. Although becoming older does not necessarily correlate with increasing illness, aging is associated with anatomical and physiological changes that affect how medications are metabolized by the body. Furthermore, aging is often related to an increased frequency of chronic illness (often combined with multiple health problems) and an increased use of medications. Thus, a better understanding of the absorption, distribution, metabolism, and excretion of drugs; of the physiologic responses to those medications; as well as of the interactions among multiple medications is crucial for improving the health of older people.
Author : Dieter Hauschke
Publisher : John Wiley & Sons
ISBN 13 : 0470094761
Total Pages : 328 pages
Book Rating : 4.4/5 (7 download)
Download or read book Bioequivalence Studies in Drug Development written by Dieter Hauschke and published by John Wiley & Sons. This book was released on 2007-03-13 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.
