Pharmacokinetics in Drug Development

Advances and Applications

Author: Peter L. Bonate,Danny R. Howard

Publisher: Springer Science & Business Media

ISBN: 9781441979377

Category: Medical

Page: 319

View: 2407

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.
Posted in Medical

Nonautonomous Dynamical Systems in the Life Sciences

Author: Peter E. Kloeden,Christian Pötzsche

Publisher: Springer

ISBN: 3319030809

Category: Mathematics

Page: 314

View: 9073

Nonautonomous dynamics describes the qualitative behavior of evolutionary differential and difference equations, whose right-hand side is explicitly time dependent. Over recent years, the theory of such systems has developed into a highly active field related to, yet recognizably distinct from that of classical autonomous dynamical systems. This development was motivated by problems of applied mathematics, in particular in the life sciences where genuinely nonautonomous systems abound. The purpose of this monograph is to indicate through selected, representative examples how often nonautonomous systems occur in the life sciences and to outline the new concepts and tools from the theory of nonautonomous dynamical systems that are now available for their investigation.
Posted in Mathematics

Mechanical and Chemical Signaling in Angiogenesis

Author: Cynthia A Reinhart-King

Publisher: Springer Science & Business Media

ISBN: 3642308562

Category: Technology & Engineering

Page: 282

View: 3370

This volume describes and discusses recent advances in angiogenesis research. The chapters are organized to address all biological length scales of angiogenesis: molecular, cellular and tissue in both in vivo and in vitro settings. Specific emphasis is given to novel methodologies and biomaterials that have been developed and applied to angiogenesis research. Angiogenesis experts from diverse fields including engineering, cell and developmental biology, chemistry and physics will be invited to contribute chapters which focus on the mechanical and chemical signals which affect and promote angiogenesis.
Posted in Technology & Engineering

3D QSAR in Drug Design

Recent Advances

Author: Hugo Kubinyi,Gerd Folkers,Yvonne C. Martin

Publisher: Springer Science & Business Media

ISBN: 0306468581

Category: Science

Page: 353

View: 8649

Significant progress has been made in the study of three-dimensional quantitative structure-activity relationships (3D QSAR) since the first publication by Richard Cramer in 1988 and the first volume in the series, 3D QSAR in Drug Design. Theory, Methods and Applications, published in 1993. The aim of that early book was to contribute to the understanding and the further application of CoMFA and related approaches and to facilitate the appropriate use of these methods. Since then, hundreds of papers have appeared using the quickly developing techniques of both 3D QSAR and computational sciences to study a broad variety of biological problems. Again the editor(s) felt that the time had come to solicit reviews on published and new viewpoints to document the state of the art of 3D QSAR in its broadest definition and to provide visions of where new techniques will emerge or new appli- tions may be found. The intention is not only to highlight new ideas but also to show the shortcomings, inaccuracies, and abuses of the methods. We hope this book will enable others to separate trivial from visionary approaches and me-too methodology from in- vative techniques. These concerns guided our choice of contributors. To our delight, our call for papers elicited a great many manuscripts.
Posted in Science

Advanced Methods of Pharmacokinetic and Pharmacodynamic Systems Analysis

Author: David D'Argenio

Publisher: Springer Science & Business Media

ISBN: 0306485230

Category: Medical

Page: 318

View: 1406

Advanced Methods of Pharmacokinetic and Pharmocodynamic Systems Analysis Volume 3 is vital to professionals and academicians working in drug development and bioengineering. Both basic and clinical scientists will benefit from this work. This book contains chapters by leading researchers in pharmacokinetic/pharmacodynamic modeling and will be of interest to anyone involved with the application of pharmacokinetic and pharmacodynamics to drug development. The use of mathematical modeling and associated computational methods is central to the study of the absorption, distribution and elimination of therapeutic drugs (pharmacokinetics) and to understanding how drugs produce their effects (pharmacodynamics). From its inception, the field of pharmacokinetics and pharmacodynamics has incorporated methods of mathematical modeling, simulation and computation in an effort to better understand and quantify the processes of uptake, disposition and action of therapeutic drugs. These methods for pharmacokinetic/pharmacodynamic systems analysis impact all aspects of drug development. In vitro, animal and human testing, as well as drug therapy are all influenced by these methods. Modeling methodologies developed for studying pharmacokinetic/ pharmacodynamic processes confront many challenges. This is related in part to the severe restrictions on the number and type of measurements that are available from laboratory experiments and clinical trials, as well as the variability in the experiments and the uncertainty associated with the processes themselves. The contributions are organized in three main areas: Mechanism-Based PK/PD, Pharmacometrics and Pharmacotherapy. Both professionals and academics will profit from this extensive work.
Posted in Medical

Bioequivalence Studies in Drug Development

Methods and Applications

Author: Dieter Hauschke,Volker Steinijans,Iris Pigeot

Publisher: John Wiley & Sons

ISBN: 0470094761

Category: Medical

Page: 328

View: 3528

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.
Posted in Medical

Advances in Communications

Volume 1: Advances in Communications Volume 2: Advances in Control Volume 3: Applications of Information and Control Systems

Author: D.G. Lainiotis,N.S. Tzannes

Publisher: Springer Science & Business Media

ISBN: 9789027711403

Category: Technology & Engineering

Page: 524

View: 2068

V.1 - Advances in communications; v.2 - Advances in control; v.3 - Applications of information and control systems.
Posted in Technology & Engineering

Handbook of Pharmacokinetic/Pharmacodynamic Correlation

Author: Hartmut Derendorf,Guenther Hochhaus

Publisher: CRC Press

ISBN: 9780849383038

Category: Medical

Page: 496

View: 1681

Combining the established disciplines of pharmacokinetics (PK), the relationship between drug concentration and time, and pharmacodynamics (PD), the relationship between drug effects and concentration, this handbook examines the relevant relationship between drug effects and time. It provides a systematic overview of how PK is linked to PD, introduces the basic concepts of PK-PD modeling and presents the underlying theory behind it, and discusses the specific aspects of PK-PD modeling for various classes of drugs.
Posted in Medical

Advances in QSAR Modeling

Applications in Pharmaceutical, Chemical, Food, Agricultural and Environmental Sciences

Author: Kunal Roy

Publisher: Springer

ISBN: 3319568507

Category: Science

Page: 555

View: 5372

The book covers theoretical background and methodology as well as all current applications of Quantitative Structure-Activity Relationships (QSAR). Written by an international group of recognized researchers, this edited volume discusses applications of QSAR in multiple disciplines such as chemistry, pharmacy, environmental and agricultural sciences addressing data gaps and modern regulatory requirements. Additionally, the applications of QSAR in food science and nanoscience have been included – two areas which have only recently been able to exploit this versatile tool. This timely addition to the series is aimed at graduate students, academics and industrial scientists interested in the latest advances and applications of QSAR.
Posted in Science

Pharmacodynamics and Drug Development

Perspectives in Clinical Pharmacology

Author: Neal R. Cutler,John J. Sramek,Prem K. Narang

Publisher: John Wiley & Sons

ISBN: 9780471950523

Category: Medical

Page: 491

View: 7685

Contains essential facts and concepts spanning many of the important drug classes. Features an authoritative section on general methodology and regulatory issues. The molecular biology and pharmacology of key receptor types are considered along with the detailed pharmacodynamics of a wide range of therapeutic drug groups.
Posted in Medical

Oral Bioavailability

Basic Principles, Advanced Concepts, and Applications

Author: Xiaoling Li

Publisher: John Wiley & Sons

ISBN: 9781118067581

Category: Medical

Page: 560

View: 3914

Understand and assess the design, delivery, and efficacy of orally administered drugs A practical guide to understanding oral bioavailability, one of the major hurdles in drug development and delivery, Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications is designed to help chemists, biologists, life science researchers, pharmaceutical scientists, pharmacologists, clinicians, and graduate and students become familiar with the fundamentals and practices of the science of oral bioavailability. The difference in rate and extent between a drug taken orally and the actual amount of a drug reaching the circulatory system, oral bioavailability is an essential parameter for determining the efficacy and adverse effects of new and developing medications, as well as finding an optimal dosing regimen. This book provides a much-needed one-stop resource to help readers better understand and appreciate the many facets and complex problems of oral bioavailability, including the basic barriers to oral bioavailability, the methods used to determine relevant parameters, and the challenges of drug delivery. In addition, this comprehensive book discusses biological and physicochemical methods for improving bioavailability, integrates physicochemistry with physiology and molecular biology, and includes several state-of-the-art technologies and approaches—Caco-2 cell culture model, MDCK, and other related cell culture models—which are used to study the science of oral bioavailability.
Posted in Medical

Pharmaceutical Biotechnology

Drug Discovery and Clinical Applications

Author: Oliver Kayser,Heribert Warzecha

Publisher: John Wiley & Sons

ISBN: 352765125X

Category: Science

Page: 676

View: 3941

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Posted in Science

Clinical Trial Simulations

Applications and Trends

Author: Holly H. C. Kimko,Carl C. Peck

Publisher: Springer Science & Business Media

ISBN: 9781441974150

Category: Medical

Page: 540

View: 7185

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
Posted in Medical

Antisense Drug Technology

Principles, Strategies, and Applications, Second Edition

Author: Stanley T. Crooke

Publisher: CRC Press

ISBN: 0849387957

Category: Medical

Page: 848

View: 2447

Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research. Interpreting lessons learned from the clinical trials of first generation drugs, the book evaluates the technology as a whole and offers new directions and avenues of research and development. Divided into five parts, the book begins with a thorough introduction to the mechanism of antisense drug action including the RNase H mechanism, small RNA silencing pathways, and the potential therapeutics of splice switching oligonucleotides. Leading researchers demonstrate the basics of oligonucleotide therapeutics in part two by delineating medicinal chemistry, pharmacokinetics, and delivery routes such as liposomal formulations for nucleic acid delivery. Part three details hybridization based drugs and considers the dramatic advances represented by 2’ methoxyethyl chimeric antisense inhibitors and duplex RNA drugs. Other chemical classes of drugs and mechanisms of action are described in part four with further discussions on improving the second generation antisense drugs. The final part delves deeply into therapeutic applications. Contributing authors examine the potential of antisense drugs for the alleviation of cardiovascular diseases, metabolic diseases, inflammatory diseases, cancer, neurological disorders, and immune modulation. Presenting a highly detailed, lucid discussion of the remarkable advances in the field, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition provides the platform for researchers to continue to aggressively pursue the great opportunity represented by this exciting technology.
Posted in Medical

Drugs—Advances in Research and Application: 2013 Edition

Author: N.A

Publisher: ScholarlyEditions

ISBN: 1481699598

Category: Medical

Page: 617

View: 5581

Drugs—Advances in Research and Application / 2013 Edition is a ScholarlyEditions™ book that delivers timely, authoritative, and comprehensive information about Drug Classes. The editors have built Drugs—Advances in Research and Application: 2013 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Drug Classes in this book to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Drugs—Advances in Research and Application: 2013 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Posted in Medical

Recent Advances and Future Directions in Trauma Care, An Issue of Surgical Clinics - E-Book

Author: Jeremy W. Cannon

Publisher: Elsevier Health Sciences

ISBN: 1455747912

Category: Medical

Page: 240

View: 6495

An important review on trauma for the general surgeon! Topics include spectrum of TBI from mild to severe, management of complex extremity injuries, long-range ICU transport, advanced technologies in trauma/CC management, non-compressible torso hemorrhage, trauma system configurations in other countries, graduate medical education in trauma/CC and acute care surgery, improving care in the trauma ICU, damage control surgery, massive transfusion and damage control resuscitation, burn/electrical/environmental injury resuscitation, pre-hospital management and tactical combat casualty care, research and analytics in trauma care, verification and regionalization of trauma systems, and more!
Posted in Medical

Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition

Author: Johan Gabrielsson,Daniel Weiner

Publisher: CRC Press

ISBN: 9789186274924

Category: Medical

Page: 924

View: 9110

This is a revised and very expanded version of the previous second edition of the book. "Pharmacokinetic and Pharmacodynamic Data Analysis" provides an introduction into pharmacokinetic and pharmacodynamic concepts using simple illustrations and reasoning. It describes ways in which pharmacodynamic and pharmacodynamic theory may be used to give insight into modeling questions and how these questions can in turn lead to new knowledge. This book differentiates itself from other texts in this area in that it bridges the gap between relevant theory and the actual application of the theory to real life situations. The book is divided into two parts; the first introduces fundamental principles of PK and PD concepts, and principles of mathematical modeling, while the second provides case studies obtained from drug industry and academia. Topics included in the first part include a discussion of the statistical principles of model fitting, including how to assess the adequacy of the fit of a model, as well as strategies for selection of time points to be included in the design of a study. The first part also introduces basic pharmacokinetic and pharmacodynamic concepts, including an excellent discussion of effect compartment (link) models as well as indirect response models. The second part of the text includes over 70 modeling case studies. These include a discussion of the selection of the model, derivation of initial parameter estimates and interpretation of the corresponding output. Finally, the authors discuss a number of pharmacodynamic modeling situations including receptor binding models, synergy, and tolerance models (feedback and precursor models). This book will be of interest to researchers, to graduate students and advanced undergraduate students in the PK/PD area who wish to learn how to analyze biological data and build models and to become familiar with new areas of application. In addition, the text will be of interest to toxicologists interested in learning about determinants of exposure and performing toxicokinetic modeling. The inclusion of the numerous exercises and models makes it an excellent primary or adjutant text for traditional PK courses taught in pharmacy and medical schools. A diskette is included with the text that includes all of the exercises and solutions using WinNonlin.
Posted in Medical

Biodrug Delivery Systems

Fundamentals, Applications and Clinical Development

Author: Mariko Morishita,Kinam Park

Publisher: CRC Press

ISBN: 1420086715

Category: Medical

Page: 488

View: 2345

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses components of successful formulation, delivery, and production of biodrugs, which include sophisticated plants and complex processes, a well-trained and knowledgeable staff, and proper quality control. In addition, the authors examine: ADME (Absorption, Metabolism, Distribution, and Elimination of biodrugs) Directing and influencing the successful development of currently marketed best-selling biodrugs Routes of administration Mechanisms of biodrug absorption Alternative possibilities for drug delivery routes Formulationson the market from the perspective of industry personnel involved in biodrug development
Posted in Medical

Advances in Blood Research and Application: 2011 Edition

Author: N.A

Publisher: ScholarlyEditions

ISBN: 1464921903

Category: Medical

Page: 426

View: 1229

Advances in Blood Research and Application / 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Blood. The editors have built Advances in Blood Research and Application: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Blood in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Advances in Blood Research and Application: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.
Posted in Medical

Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial Scientists

Author: Younggil Kwon

Publisher: Springer Science & Business Media

ISBN: 0306468204

Category: Medical

Page: 291

View: 1090

In the pharmaceutical industry, the incorporation of the disciplines of pharma- kinetics, pharmacodynamics, and drug metabolism (PK/PD/DM) into various drug development processes has been recognized to be extremely important for approp- ate compound selection and optimization. During discovery phases, the identifi- tion of the critical PK/PD/DM issues of new compounds plays an essential role in understanding their pharmacological profiles and structure-activity relationships. Owing to recent progress in analytical chemistry, a large number of compounds can be screened for their PK/PD/DM properties within a relatively short period of time. During development phases as well, the toxicology and clinical study designs and trials of a compound should be based on a thorough understanding of its PK/PD/DM properties. During my time as an industrial scientist, I realized that a reference work designed for practical industrial applications of PK/PD/DM could be a very valuable tool for researchers not only in the pharmacokinetics and drug metabolism departments, but also for other discovery and development groups in pharmaceutical companies. This book is designed specifically for industrial scientists, laboratory assistants, and managers who are involved in PK/PD/DM-related areas. It consists of thirteen chapters, each of which deals with a particular PK/PD/DM issue and its industrial applications. Chapters 3 and 12 in particular address recent topics on higher throughput in vivo exposure screening and the prediction of pharmacokinetics in humans, respectively. Chapter 8 covers essential information on drug metabolism for industrial scientists.
Posted in Medical