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.

This casebook is designed to help students develop the skills required to identify and resolve drug therapy problems through the use of patient case studies.

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.

Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Preface to the Fourth Edition -- Preface to the Third Edition -- Preface to the Second Edition -- Preface to the First Edition -- Nomenclature -- 1: Introduction -- References -- 2: Rates, Rate Constants, and Order -- I. Order -- II. Rates and Rate Constants -- 3: Active and Passive Transport -- I. Introduction -- II. Passive Transport -- III. Active Transport -- References -- 4: Pharmacokinetics -- I. Introduction -- II. Drug Disposition -- III. Constant-Rate Intravenous Infusion -- IV. Compartmental Models and Their Limitations -- V. Absorption Rate Constants -- References -- 5: Biopharmaccutics -- I. Extravascular Administration -- II. Absorption of Drugs from the Gastrointestinal Tract -- III. Factors Influencing Bioavailability -- IV. Evaluation of the Bioavailability of a Single Drug -- V. Drug Delivery to Prolong Duration -- References -- 6: Dosage Regimens -- I. Introduction -- II. Accumulation During Repetitive Dosing -- III. Adjustment of Dosage Regimen in Renal Failure -- IV. Multiple Dosing of Constant-Rate Intravenous Infusions -- References -- 7: Pharmacokinetic Aspects of Structural Modifications in Drug Design and Therapy -- I. Introduction -- II. Antimicrobial Agents -- III. Pharmacokinetics of Prodrugs -- IV. Stereoisomers -- References -- 8: Pharmacokinetic Applications in Clinical Practice -- I. Introduction -- II. Pharmacokinetic Drug Interactions -- III. Clinical Pharmacokinetics -- References -- Appendix -- Index

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.

Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.

This book deals with the basics of the two disciplines of biopharmaceutics and pharmacokinetics. Different factors such as biological, physiochemical and formulation that influence the therapeutic efficacy of a drug are covered in biopharmaceutics. The absorption, distribution, metabolism and excretion of drugs are studied under this subject. Salient Features - Basics of biopharmaceutics and pharmacokinetics help to understand the various procedures and advances in drug design, product development, therapeutic drug monitoring, etc. - Pharmacokinetics covers the fundamentals of one compartment open model, multi-compartmental models. One compartment open model is presented in an elaborate manner to make the students familiar with various aspects of pharmacokinetics - Mathematical equations are developed using simple integration and differentiation methods - Practice problems are provided wherever necessary, and a question bank is included at the end of each chapter - Extreme care has been exercised to present the concepts in a simple way Second Edition includes - Application of principles in formulation development in industry for successful bioequivalence studies is included - One chapter on "In-vitro Dissolution Testing" is included to evaluate test formulations to chose right product for bioequivalence studies - A chapter on biostatistics with practice problems is included