Download or read book Physiologically Based Population Pharmacokinetic pharmacodynamic Modeling and Simulation Approaches to Support Waivers of in Vivo Clinical Pharmacology Studies written by Ioannis Loisios-Konstantinidis and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 634 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.
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 2021-09-30 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations The first book dedicated to the emerging field of physiologically based pharmacokinetic modeling (PBPK) Now in its second edition, Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulations: Principles, Methods, and Applications in the Pharma Industry remains the premier reference book throughout the rapidly growing PBPK user community. Using clear and concise language, author Sheila Annie Peters connects theory with practice as she explores the vast potential of PBPK modeling for improving drug discovery and development. This fully updated new edition covers key developments in the field of PBPK modelling and simulations that have emerged in recent years. A brand-new section provides case studies in different application areas of PBPK modelling, including drug-drug interaction, genetic polymorphism, renal impairment, and pediatric extrapolation. Additional chapters address topics such as model-informed drug development (MIDD) and expose readers to a wide range of current applications in the field. Throughout the book, substantially revised chapters simplify complex topics and offer a balanced view of both the opportunities and challenges of PBPK modelling. Providing timely and comprehensive coverage of one of the most exciting new areas of pharmaceutical science, this book: Describes the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics Features a wealth of new figures and case studies of the applications of PBPK modelling along the value chain in drug discovery and development Reflects the latest regulatory guidelines on the reporting of PBPK modelling analysis Includes access to a new companion website containing code, datasets, explanations of case examples in the text, and discussion of key developments in the field Contains a brief overview of the field, end-of-chapter keywords for easy reference, and an extensive bibliography Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, Second Edition is an indispensable single-volume resource for beginning and intermediate practitioners across the pharmaceutical sciences in both industry and academia.
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.
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.
Download or read book The Art and Science of Physiologically Based Pharmacokinetics Modeling written by Rodrigo Cristofoletti and published by CRC Press. This book was released on 2024-07-15 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.g., guiding drug discovery and development, and supporting precision medicine initiatives. To incorporate state-of-the-art knowledge, each chapter is written by leaders in the field and illustrated by clear case studies. Connecting basic and applied science, this book explores the potential of PBPK modeling for improving therapeutics and is designed for a wide audience encompassing graduate students as well as biopharmaceutics scientists and clinical pharmacologists. Features: 1. Provides a basic understanding of the physiologically-based pharmacokinetic modeling and its applications 2. Assists the reader in understanding product performance to allow for rapid product development and establish bioequivalence 3. Well-constructed content and added value of real examples 4. Illustrates how using available resources via modeling and simulation leads to a reduction in the costs related to drug development, which directly affects the costs to patients
Download or read book Physiologically Based Pharmacokinetic PBPK Modeling written by Jeffrey W. Fisher and published by Academic Press. This book was released on 2020-05-20 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physiologically Based Pharmacokinetic (PBPK) Modeling: Methods and Applications in Toxicology and Risk Assessment presents foundational principles, advanced techniques and applications of PBPK modeling. Contributions from experts in PBPK modeling cover topics such as pharmacokinetic principles, classical physiological models, the application of physiological models for dose-response and risk assessment, the use of in vitro information, and in silico methods. With end-of-chapter exercises that allow readers to practice and learn the skills associated with PBPK modeling, dose-response, and its applications to safety and risk assessments, this book is a foundational resource that provides practical coverage of PBPK modeling for graduate students, academics, researchers, and more. Provides end-of-chapter exercises to teach hands-on computational tools used in toxicology Supplies computer code and explanations and includes examples of applied models used in regulatory toxicology and research Authored by expert editors and contributors who are among the best PBPK modelers in the world
Download or read book Basic Pharmacokinetics and Pharmacodynamics written by Sara E. Rosenbaum and published by John Wiley & Sons. This book was released on 2016-11-28 with total page 816 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)
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
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 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a user-friendly, hands-on introduction to the Nonlinear Mixed Effects Modeling (NONMEM) system, the most powerful tool for pharmacokinetic / pharmacodynamic analysis. • Introduces requisite background to using Nonlinear Mixed Effects Modeling (NONMEM), covering data requirements, model building and evaluation, and quality control aspects • Provides examples of nonlinear modeling concepts and estimation basics with discussion on the model building process and applications of empirical Bayesian estimates in the drug development environment • Includes detailed chapters on data set structure, developing control streams for modeling and simulation, model applications, interpretation of NONMEM output and results, and quality control • Has datasets, programming code, and practice exercises with solutions, available on a supplementary website
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 2006-04-18 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmacokinetics in Drug Development written by Peter L. Bonate and published by Springer. This book was released on 2016-10-06 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.
Download or read book Regulatory Toxicology written by Franz-Xaver Reichl and published by Springer. This book was released on 2014-03-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.
Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an
Download or read book Drug Discovery and Development written by Vishwanath Gaitonde and published by BoD – Books on Demand. This book was released on 2020-03-11 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.
Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Download or read book Applied Pharmacometrics written by Stephan Schmidt and published by Springer. This book was released on 2014-12-01 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.
