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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.
Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. - Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences - Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics - Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology
Updated with the latest clinical advances, Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics, Fifth Edition , explains the relationship between drug administration and drug response, taking a conceptual approach that emphasizes clinical application rather than science and mathematics. Bringing a real-life perspective to the topic, the book simplifies concepts and gives readers the knowledge they need to better evaluate drug applications.
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.
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.
With its clear, straightforward presentation, this text enables you to grasp all the fundamental concepts of pharmacokinetics and pharmacodynamics. This will allow you to understand the time course of drug response and dosing regimen design. Clinical models for concentration and response are described and built from the basic concepts presented in earlier chapters. Your understanding of the material will be enhanced by guided computer exercises conducted on a companion website. Simulations will allow you to visualize drug behavior, experiment with different dosing regimens, and observe the influence of patient characteristics and model parameters. This makes the book ideal for self-study. By including clinical models of agonism, indirect drug effects, tolerance, signal transduction, and disease progression, author Sara Rosenbaum has created a work that stands out among introductory-level textbooks in this area.You'll find several features throughout the text to help you better understand and apply key concepts: Three fictitious drugs are used throughout the text to progressively illustrate the development and application of pharmacokinetic and pharmacodynamic principles Exercises at the end of each chapter reinforce the concepts and provide the opportunity to perform and solve common dosing problems Detailed instructions let you create custom Excel worksheets to perform simple pharmacokinetic analyses Because this is an introductory textbook, the material is presented as simply as possible. As a result, you'll find it easy to gain an accurate, working knowledge of all the core principles, apply them to optimize dosing regimens, and evaluate the clinical pharmacokinetic and pharmacodynamic literature.
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.
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)
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.
The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.