Biopharmaceutics Modeling and Simulations
Biopharmaceutics Modeling and Simulations

Author: Kiyohiko Sugano

Publisher: John Wiley & Sons

Published: 2012-07-31

Total Pages: 520

ISBN-13: 111835432X

DOWNLOAD EBOOK

A comprehensive introduction to using modeling and simulation programs in drug discovery and development Biopharmaceutical modeling has become integral to the design and development of new drugs. Influencing key aspects of the development process, including drug substance design, formulation design, and toxicological exposure assessment, biopharmaceutical modeling is now seen as the linchpin to a drug's future success. And while there are a number of commercially available software programs for drug modeling, there has not been a single resource guiding pharmaceutical professionals to the actual tools and practices needed to design and test safe drugs. A guide to the basics of modeling and simulation programs, Biopharmaceutics Modeling and Simulations offers pharmaceutical scientists the keys to understanding how they work and are applied in creating drugs with desired medicinal properties. Beginning with a focus on the oral absorption of drugs, the book discusses: The central dogma of oral drug absorption (the interplay of dissolution, solubility, and permeability of a drug), which forms the basis of the biopharmaceutical classification system (BCS) The concept of drug concentration How to simulate key drug absorption processes The physiological and drug property data used for biopharmaceutical modeling Reliable practices for reporting results With over 200 figures and illustrations and a peerless examination of all the key aspects of drug research—including running and interpreting models, validation, and compound and formulation selection—this reference seamlessly brings together the proven practical approaches essential to developing the safe and effective medicines of tomorrow.

Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations
Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations

Author: Sheila Annie Peters

Publisher: John Wiley & Sons

Published: 2012-02-17

Total Pages: 399

ISBN-13: 1118140303

DOWNLOAD EBOOK

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.

Computational Pharmaceutics
Computational Pharmaceutics

Author: Defang Ouyang

Publisher: John Wiley & Sons

Published: 2015-07-20

Total Pages: 350

ISBN-13: 1118573994

DOWNLOAD EBOOK

Molecular modeling techniques have been widely used in drug discovery fields for rational drug design and compound screening. Now these techniques are used to model or mimic the behavior of molecules, and help us study formulation at the molecular level. Computational pharmaceutics enables us to understand the mechanism of drug delivery, and to develop new drug delivery systems. The book discusses the modeling of different drug delivery systems, including cyclodextrins, solid dispersions, polymorphism prediction, dendrimer-based delivery systems, surfactant-based micelle, polymeric drug delivery systems, liposome, protein/peptide formulations, non-viral gene delivery systems, drug-protein binding, silica nanoparticles, carbon nanotube-based drug delivery systems, diamond nanoparticles and layered double hydroxides (LDHs) drug delivery systems. Although there are a number of existing books about rational drug design with molecular modeling techniques, these techniques still look mysterious and daunting for pharmaceutical scientists. This book fills the gap between pharmaceutics and molecular modeling, and presents a systematic and overall introduction to computational pharmaceutics. It covers all introductory, advanced and specialist levels. It provides a totally different perspective to pharmaceutical scientists, and will greatly facilitate the development of pharmaceutics. It also helps computational chemists to look for the important questions in the drug delivery field. This book is included in the Advances in Pharmaceutical Technology book series.

In Vitro-In Vivo Correlations
In Vitro-In Vivo Correlations

Author: David B. Young

Publisher: Springer Science & Business Media

Published: 2013-03-08

Total Pages: 299

ISBN-13: 1468460366

DOWNLOAD EBOOK

This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.

Biopharmaceutics Applications in Drug Development
Biopharmaceutics Applications in Drug Development

Author: Rajesh Krishna

Publisher: Springer Science & Business Media

Published: 2007-09-20

Total Pages: 416

ISBN-13: 038772379X

DOWNLOAD EBOOK

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.

Oral Drug Absorption
Oral Drug Absorption

Author: Jennifer B. Dressman

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 432

ISBN-13: 1420077341

DOWNLOAD EBOOK

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

Basic Pharmacokinetics and Pharmacodynamics
Basic Pharmacokinetics and Pharmacodynamics

Author: Sara E. Rosenbaum

Publisher: John Wiley & Sons

Published: 2016-11-22

Total Pages: 589

ISBN-13: 1119143160

DOWNLOAD EBOOK

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)

Simulation for Designing Clinical Trials
Simulation for Designing Clinical Trials

Author: Hui Kimko

Publisher: CRC Press

Published: 2002-12-12

Total Pages: 424

ISBN-13: 0203910273

DOWNLOAD EBOOK

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

Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations

Author: Sheila Annie Peters

Publisher: John Wiley & Sons

Published: 2021-09-30

Total Pages: 644

ISBN-13: 1119497795

DOWNLOAD EBOOK

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.

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

Author: Johan Gabrielsson

Publisher: CRC Press

Published: 2001-11-30

Total Pages: 926

ISBN-13: 9789186274924

DOWNLOAD EBOOK

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.