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Applications of Pharmacokinetic Principles in Drug Development

Applications of Pharmacokinetic Principles in Drug Development
Author: Rajesh Krishna
Publisher: Springer Science & Business Media
Total Pages: 556
Release: 2012-12-06
Genre: Medical
ISBN: 1441992162

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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.


Basic Principles of Drug Discovery and Development

Basic Principles of Drug Discovery and Development
Author: Benjamin E. Blass
Publisher: Academic Press
Total Pages: 712
Release: 2021-03-30
Genre: Medical
ISBN: 0128172150

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Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator’s fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist’s early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry


Pharmacokinetics in Drug Discovery and Development

Pharmacokinetics in Drug Discovery and Development
Author: Ronald D. Schoenwald
Publisher: CRC Press
Total Pages: 430
Release: 2002-03-06
Genre: Medical
ISBN: 1420010085

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Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existi


Pharmacokinetics and Adverse Effects of Drugs

Pharmacokinetics and Adverse Effects of Drugs
Author: Ntambwe Malangu
Publisher: BoD – Books on Demand
Total Pages: 164
Release: 2018-05-23
Genre: Medical
ISBN: 1789231388

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This book is a fruit of a collaborative work from several international scientists. It will be a useful resource for researchers, students, and clinicians. Each individual chapter could serve as a prescribed reading for postgraduate students and clinicians specializing in and practicing clinical pharmacology and toxicology, pharmacotherapy and pharmacotherapeutics, pharmacovigilance, and toxicovigilance, as well as those involved in clinical research, drug discovery, and development. Every chapter in this book discusses and provides illustrations on the theme discussed based on authors' understanding and experience while summarizing existing knowledge. In doing so, each chapter provides a new insight that would benefit a novice as well as a seasoned reader in understanding the pharmacokinetic mechanisms and risk factors involved in the occurrence of adverse effects of drugs.


Drug Disposition and Pharmacokinetics

Drug Disposition and Pharmacokinetics
Author: Stephen H. Curry
Publisher: John Wiley & Sons
Total Pages: 484
Release: 2022-10-03
Genre: Science
ISBN: 111958843X

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Drug Disposition and Pharmacokinetics The most up-to-date edition of a leading reference in drug disposition and pharmacokinetics In this new, fully-revised edition of Drug Disposition and Pharmacokinetics: Principles and Applications for Medicine, Toxicology and Biotechnology the authors deliver an authoritative and comprehensive discussion of the fate of drug molecules in the body, as well as its implications for pharmacological and clinical effects. The text offers a unique and balanced approach that combines discussion of the specific physical and biological factors affecting the absorption, distribution, metabolism, and excretion of drugs, with mathematical assessments of plasma and body fluid concentrations. The book assumes little prior knowledge and is an ideal reference for practicing professionals in industry as well as researchers and academics. This latest edition provides readers with a new introductory chapter, as well as new chapters covering monoclonal antibodies, the role of stereochemistry in drug disposition and pharmacokinetics, DMPK in non-human species, and the recent use of AI in drug development. Readers will also find: Thorough introductions to drug disposition, pharmacokinetics, and pharmacokinetic modeling In-depth treatments of the kinetics of drug elimination and the relationship between concentration and effect, including PK–PD modeling Comprehensive discussions of predictive pharmacokinetics and the disposition of biological molecules, including peptides and monoclonal antibodies Detailed examinations of the effects of sex, pregnancy, age, and disease, as well as drug monitoring in therapeutics and the use of AI in drug development and treatment Perfect for professionals and researchers working with the scientific aspects of drug disposition in human and veterinary medicine, toxicology, and pharmacology. Drug Disposition and Pharmacokinetics will earn a place in the libraries of students of senior-level courses in pharmacy.


Introduction to Drug Disposition and Pharmacokinetics

Introduction to Drug Disposition and Pharmacokinetics
Author: Stephen H. Curry
Publisher: John Wiley & Sons
Total Pages: 340
Release: 2017-01-30
Genre: Science
ISBN: 111926104X

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The application of knowledge of drug disposition, and skills in pharmacokinetics, are crucial to the development of new drugs and to a better understanding of how to achieve maximum benefit from existing ones. The book takes the reader from basic concepts to a point where those who wish to will be able to perform pharmacokinetic calculations and be ready to read more advanced texts and research papers. The book will be of benefit to students of medicine, pharmacy, pharmacology, biomedical sciences and veterinary science, including those who have elected to study the topic in more detail, such as via electives and special study modules. It will be of benefit to those involved in drug discovery and development, pharmaceutical and medicinal chemists, as well as budding toxicologists and forensic scientists who require the appropriate knowledge to interpret their findings and as an introductory text for clinical pharmacologists. Early chapters describe the basic principles of the topic while the later ones illustrate the application of those principles to modern approaches to drug development and clinical use. Full colour illustrations facilitate the learning experience and supporting material for course leaders and students can be found on the Companion Web Site "Another book on PK? Yes and there should be and it should be DD & PK. It is good, unique, and does fill a currently unmet need for those working in the xenobiotic arena. DD & PK is just like the perfect mystery novel—the one “you just can’t put down.” However, unlike a mystery novel which requires only one reading to find the answer, the reader of DD & PK will learn more than an answer to a single question. The reader will find many solutions to a wide variety of mysterious problems associated with the time course and actions of xenobiotics." —International Journal of Toxicology, John A. Budny, PhD, President, PharmaCal, Ltd, 2018 "This book has many innovations that make a welcome addition to the bookshelves of a wide range of pharmaceutical scientists. The effective use of figures and tables to summarize and clarify a wide range of issues is to be commended, as are the learning objectives at the start of the chapter coupled with the summary at the end providing a succinct way in understanding the objectives of the chapter and together with links to a website provides accessibility for all from the neophyte pharmacokineticist to the consultant physician. A book all in the Pharma industry should be aware of." —Int. J. of Pharmacokinetics, Howard M. Hill, ResolvPharma, 2018 "Overall, Introduction to Drug Disposition and Pharmacokinetics offers its readership an in-depth view of classic pharmacokinetic concepts. This book would be an excellent choice for a pharmacokinetics elective or as an adjunctive text for an introductory course. This book reviews a wide array of clinically relevant topics and encourages the reader to apply the knowledge gained to all medi-cations. A robust and varied amount of online material is provided to enhance understanding and encourage discussion. It is likely that all readers, novice or experienced pharmacists, would find value in this textbook." — Currents in Pharmacy Teaching and Learning, Milena McLaughlin, Midwestern University Chicago College of Pharmacy, 2018 "In summary, this is an excellent textbook for students new to the field of pharmaceutics and medical, pharmacy, and veterinary students, particularly those who envision a career in drug development research in either academia or industry." —Veterinary Pathology Review, John K. Amory, University of Washington, 2018


Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Pharmacokinetics and Pharmacodynamics of Biotech Drugs
Author: Bernd Meibohm
Publisher: John Wiley & Sons
Total Pages: 426
Release: 2006-12-13
Genre: Science
ISBN: 3527609520

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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.


Pharmacokinetics in Drug Development

Pharmacokinetics in Drug Development
Author: Peter L. Bonate
Publisher: Springer Science & Business Media
Total Pages: 325
Release: 2011-02-21
Genre: Medical
ISBN: 1441979379

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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.


Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development
Author: Rajesh Krishna
Publisher: Springer Science & Business Media
Total Pages: 416
Release: 2007-09-20
Genre: Medical
ISBN: 038772379X

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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.


Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations

Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations
Author: Sheila Annie Peters
Publisher: John Wiley & Sons
Total Pages: 399
Release: 2012-02-17
Genre: Medical
ISBN: 1118140303

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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.