Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics

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Publisher : Springer Science & Business Media
ISBN 13 : 0387319107
Total Pages : 446 pages
Book Rating : 4.3/5 (873 download)

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Book Synopsis Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics by : Panos Macheras

Download or read book Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics written by Panos Macheras and published by Springer Science & Business Media. This book was released on 2006-04-26 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a novel modeling approach to biopharamceutics, pharmacokinetics and pharmacodynamic phenomena. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. Throughout, many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

Pharmacokinetic-Pharmacodynamic Modeling and Simulation

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Publisher : Springer Science & Business Media
ISBN 13 : 1441994858
Total Pages : 618 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Pharmacokinetic-Pharmacodynamic Modeling and Simulation by : Peter L. Bonate

Download or read book Pharmacokinetic-Pharmacodynamic Modeling and Simulation written by Peter L. Bonate and published by Springer Science & Business Media. This book was released on 2011-07-01 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated.

Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics

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Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781977925770
Total Pages : 442 pages
Book Rating : 4.9/5 (257 download)

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Book Synopsis Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics by : Robert Bishop

Download or read book Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics written by Robert Bishop and published by Createspace Independent Publishing Platform. This book was released on 2017-08-15 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with epirical, compartmental, and stochastic pharmacokinetic models, with two new chapters, one on fractional pharmacokinetics and one on bioequivalence; and the fourth mainly with classical and nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. This second edition has new information on reaction limited models of dissolution, non binary biopharmaceutic classification system, time varying models, and interface models.

Advanced Methods of Pharmacokinetic and Pharmacodynamic Systems Analysis

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Publisher : Springer Science & Business Media
ISBN 13 : 147579021X
Total Pages : 202 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Advanced Methods of Pharmacokinetic and Pharmacodynamic Systems Analysis by : David D'Argenio

Download or read book Advanced Methods of Pharmacokinetic and Pharmacodynamic Systems Analysis written by David D'Argenio and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume records the proceedings of the Workshop on Advanced Meth ods of Pharmacokinetic and Pharmacodynamic Systems Analysis, organized by the Biomedical Simulations Resource in May 1990. The meeting brought together over 120 investigators from a number of disciplines, including clinical pharmacology, clinical pharmacy, pharmaceutical science, biomathematics, statistics and biomed ical engineering with the purpose of providing a high-level forum to facilitate the exchange of ideas between basic and clinical research scientists, experimentalists and modelers working on problems in pharmacokinetics and pharmacodynamics. It has been my experience that in many areas of biomedical research, when a meeting of this type is held, the general attitude of those experimentalists willing to attend is one of extreme skepticism: as a group they feel that mathematical modeling has little to offer them in furthering their understanding of the particular biological processes they are studying. This is certainly not the prevailing view when the topic is pharmacokinetics and drug response. Quite the contrary, the use of mathemati cal modeling and associated data analysis and computational methods has been a central feature of pharmacokinetics almost from its beginnings. In fact, the field has borrowed techniques of modeling from other disciplines including applied math ematics, statistics and engineering, in an effort to better describe and understand the processes of drug disposition and drug response.

Handbook of Pharmacokinetic/Pharmacodynamic Correlation

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Publisher : CRC Press
ISBN 13 : 9780849383038
Total Pages : 502 pages
Book Rating : 4.3/5 (83 download)

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Book Synopsis Handbook of Pharmacokinetic/Pharmacodynamic Correlation by : Hartmut Derendorf

Download or read book Handbook of Pharmacokinetic/Pharmacodynamic Correlation written by Hartmut Derendorf and published by CRC Press. This book was released on 1995-03-23 with total page 502 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

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Publisher : CRC Press
ISBN 13 : 9789186274924
Total Pages : 926 pages
Book Rating : 4.2/5 (749 download)

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Book Synopsis Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition by : Johan Gabrielsson

Download or read book Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition written by Johan Gabrielsson and published by CRC Press. This book was released on 2001-11-30 with total page 926 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Basic Pharmacokinetics and Pharmacodynamics

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Publisher : John Wiley & Sons
ISBN 13 : 1119143152
Total Pages : 589 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Basic Pharmacokinetics and Pharmacodynamics by : Sara E. Rosenbaum

Download or read book Basic Pharmacokinetics and Pharmacodynamics written by Sara E. Rosenbaum and published by John Wiley & Sons. This book was released on 2016-12-27 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated with new chapters and topics, this book provides a comprehensive description of all essential topics in contemporary pharmacokinetics and pharmacodynamics. It also features interactive computer simulations for students to experiment and observe PK/PD models in action. • Presents the essentials of pharmacokinetics and pharmacodynamics in a clear and progressive manner • Helps students better appreciate important concepts and gain a greater understanding of the mechanism of action of drugs by reinforcing practical applications in both the book and the computer modules • Features interactive computer simulations, available online through a companion website at: https://web.uri.edu/pharmacy/research/rosenbaum/sims/ • Adds new chapters on physiologically based pharmacokinetic models, predicting drug-drug interactions, and pharmacogenetics while also strengthening original chapters to better prepare students for more advanced applications • Reviews of the 1st edition: “This is an ideal textbook for those starting out … and also for use as a reference book …." (International Society for the Study of Xenobiotics) and “I could recommend Rosenbaum’s book for pharmacology students because it is written from a perspective of drug action . . . Overall, this is a well-written introduction to PK/PD …. “ (British Toxicology Society Newsletter)

Advances in Pharmacokinetics and Pharmacodynamics

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Publisher : Springer Nature
ISBN 13 : 3031295412
Total Pages : 208 pages
Book Rating : 4.0/5 (312 download)

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Book Synopsis Advances in Pharmacokinetics and Pharmacodynamics by : Panos Macheras

Download or read book Advances in Pharmacokinetics and Pharmacodynamics written by Panos Macheras and published by Springer Nature. This book was released on 2023-05-26 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a concise overview of recent advances in Pharmacokinetics (PK) and Pharmacodynamics (PD). The pharmacokinetics section covers the state of the art in Physiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2). Chapters 3 and 4 describe the recent development of Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models and their applications to pharmacokinetic data. The pharmacodynamics section focuses on PK/PD modeling. Chapter 5 provides an overview of PK/PD modeling and simulation in clinical practice and studies. Chapter 6 deals with the subject/physiology variability issue encountered in PK/PD studies, while Chapter 7 reviews the influence of clinical pharmacology in the modernization of drug development and regulation. This book is an essential reference for pharmaceutical scientists.

Simulation for Designing Clinical Trials

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Publisher : CRC Press
ISBN 13 : 0203910273
Total Pages : 424 pages
Book Rating : 4.2/5 (39 download)

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Book Synopsis Simulation for Designing Clinical Trials by : Hui Kimko

Download or read book Simulation for Designing Clinical Trials written by Hui Kimko and published by CRC Press. This book was released on 2002-12-12 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p

Holland-Frei Cancer Medicine

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Publisher : John Wiley & Sons
ISBN 13 : 111900084X
Total Pages : 2008 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Holland-Frei Cancer Medicine by : Robert C. Bast, Jr.

Download or read book Holland-Frei Cancer Medicine written by Robert C. Bast, Jr. and published by John Wiley & Sons. This book was released on 2017-03-10 with total page 2008 pages. Available in PDF, EPUB and Kindle. Book excerpt: Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates

Physiologically Based Pharmacokinetic Modeling

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Publisher : John Wiley & Sons
ISBN 13 : 0471478776
Total Pages : 420 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Physiologically Based Pharmacokinetic Modeling by : Micaela Reddy

Download or read book Physiologically Based Pharmacokinetic Modeling written by Micaela Reddy and published by John Wiley & Sons. This book was released on 2005-06-14 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: A definitive, single source of information on PBPK modeling Physiologically-based pharmacokinetic (PBPK) modeling is becomingincreasingly important in human health risk assessments and insupporting pharmacodynamic modeling for toxic responses. Organizedby classes of compounds and modeling purposes so users can quicklyaccess information, this is the first comprehensive reference ofits kind. This book presents an overview of the underlying principles of PBPKmodel development. Then it provides a compendium of PBPK modelinginformation, including historical development, specific modelingchallenges, and current practices for: * Halogenated Alkanes * Halogenated Alkenes * Alkene and Aromatic Compounds * Reactive Vapors in the Nasal Cavity * Alkanes, Oxyhydrocarbons, and Related Compounds * Pesticides and Persistent Organic Pollutants * Dioxin and Related Compounds * Metals and Inorganic Compounds * Drugs * Antineoplastic Agents * Perinatal Transfer * Mixtures * Dermal Exposure Models In addition to pinpointing specific information, readers canexplore diverse modeling techniques and applications. Anauthoritative reference for toxicologists, ecotoxicologists, riskassessors, regulators, pharmacologists, pharmacists, and graduatestudents in pharmacokinetics and toxicology, Physiologically-BasedPharmacokinetic Modeling compiles information from leaders in thefield and discusses future directions for PBPK modeling.

Applications of Pharmacokinetic Principles in Drug Development

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Publisher : Springer Science & Business Media
ISBN 13 : 1441992162
Total Pages : 556 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis Applications of Pharmacokinetic Principles in Drug Development by : Rajesh Krishna

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.

Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations

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Publisher : John Wiley & Sons
ISBN 13 : 1118140303
Total Pages : 399 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations by : Sheila Annie Peters

Download or read book Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations written by Sheila Annie Peters and published by John Wiley & Sons. This book was released on 2012-02-17 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: The only book dedicated to physiologically-based pharmacokinetic modeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Describing the principles, methods, and applications of PBPK modeling as used in pharmaceutics, Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations fills this void. Connecting theory with practice, the book explores the incredible potential of PBPK modeling for improving drug discovery and development. Comprised of two parts, the book first provides a detailed and systematic treatment of the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics. The second part looks in greater detail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for a brief overview of the field as well as those who need more detail, the book includes a range of important learning aids. Featuring end-of-chapter keywords for easy reference a valuable asset for general or novice readers without a PBPK background along with an extensive bibliography for those looking for further information, Physiologically- Based Pharmacokinetic (PBPK) Modeling and Simulations is the essential single-volume text on one of the hottest topics in the pharmaceutical sciences today.

Drug Delivery Approaches

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Publisher : John Wiley & Sons
ISBN 13 : 1119772753
Total Pages : 466 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Drug Delivery Approaches by : Bret Berner

Download or read book Drug Delivery Approaches written by Bret Berner and published by John Wiley & Sons. This book was released on 2021-08-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

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Publisher : John Wiley & Sons
ISBN 13 : 111928922X
Total Pages : 469 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases by : Honghui Zhou

Download or read book Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2019-02-14 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed. Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include: • Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins • Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins) • Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.

Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models

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Publisher : John Wiley & Sons
ISBN 13 : 1118784618
Total Pages : 320 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models by : Joel S. Owen

Download or read book Introduction to Population Pharmacokinetic / Pharmacodynamic Analysis with Nonlinear Mixed Effects Models written by Joel S. Owen and published by John Wiley & Sons. This book was released on 2014-06-19 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a user-friendly, hands-on introduction to theNonlinear Mixed Effects Modeling (NONMEM) system, the most powerfultool for pharmacokinetic / pharmacodynamic analysis. • Introduces requisite background to using NonlinearMixed Effects Modeling (NONMEM), covering data requirements, modelbuilding and evaluation, and quality control aspects • Provides examples of nonlinear modeling concepts andestimation basics with discussion on the model buildingprocess and applications of empirical Bayesian estimates in thedrug development environment • Includes detailed chapters on data set structure,developing control streams for modeling and simulation, modelapplications, interpretation of NONMEM output and results, andquality control • Has datasets, programming code, and practice exerciseswith solutions, available on a supplementary website

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

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Publisher : John Wiley & Sons
ISBN 13 : 3527609520
Total Pages : 426 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Pharmacokinetics and Pharmacodynamics of Biotech Drugs by : Bernd Meibohm

Download or read book Pharmacokinetics and Pharmacodynamics of Biotech Drugs written by Bernd Meibohm and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 426 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.