Drug Delivery Approaches

Drug Delivery Approaches
Author: Bret Berner
Publisher: John Wiley & Sons
Total Pages: 466
Release: 2021-08-31
Genre: Medical
ISBN: 1119772737

Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Excipient Applications in Formulation Design and Drug Delivery

Excipient Applications in Formulation Design and Drug Delivery
Author: Ajit S Narang
Publisher: Springer
Total Pages: 700
Release: 2015-10-07
Genre: Medical
ISBN: 3319202065

In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Integration of Pharmaceutical Discovery and Development

Integration of Pharmaceutical Discovery and Development
Author: Ronald T. Borchardt
Publisher: Springer Science & Business Media
Total Pages: 627
Release: 2006-01-19
Genre: Science
ISBN: 0306473844

In the late 1980s, it became painfully evident to the pharmaceutical industry that the old paradigm of drug discovery, which involved highly segmented drug - sign and development activities, would not produce an acceptable success rate in the future. Therefore, in the early 1990s a paradigm shift occurred in which drug design and development activities became more highly integrated. This new str- egy required medicinal chemists to design drug candidates with structural f- tures that optimized pharmacological (e. g. , high affinity and specificity for the target receptor), pharmaceutical (e. g. , solubility and chemical stability), bioph- maceutical (e. g. , cell membrane permeability), and metabolic/pharmacokinetic (e. g. , metabolic stability, clearance, and protein binding) properties. Successful implementation of this strategy requires a multidisciplinary team effort, incl- ing scientists from drug design (e. g. , medicinal chemists, cell biologists, en- mologists, pharmacologists) and drug development (e. g. , analytical chemists, pharmaceutical scientists, physiologists, and molecular biologists representing the disciplines of pharmaceutics, biopharmaceutics, and pharmacokinetics/drug metabolism). With this new, highly integrated approach to drug design now widely utilized by the pharmaceutical industry, the editors of this book have provided the sci- tific community with case histories to illustrate the nature of the interdisciplinary interactions necessary to successfully implement this new approach to drug d- covery. In the first chapter, Ralph Hirschmann provides a historical perspective of why this paradigm shift in drug discovery has occurred.

Metabolomics for Biomedical Research

Metabolomics for Biomedical Research
Author: Jerzy Adamski
Publisher: Academic Press
Total Pages: 266
Release: 2020-03-21
Genre: Medical
ISBN: 0128127848

Metabolomics for Biomedical Research brings together recent progress on study design, analytics, biostatistics and bioinformatics for the success of metabolomics research. Metabolomics represents a very interdisciplinary research prominent in the functional analyses of living systems; hence, this book focuses on translation and medical aspects. The book discusses topics such as biomarkers and their requirements to be used in medical research, with the parameters and approaches on how to validate their quality; and animal models and other approaches, as stem cells and organoid culture. Additionally, it explains how metabolomics may be applied in prediction of individual response to drug or disease progression. This book is a valuable source for researchers on systems biology and other members of biomedical field interested in metabolism-oriented studies for medical research.

Green and Sustainable Medicinal Chemistry

Green and Sustainable Medicinal Chemistry
Author: Louise Summerton
Publisher: Royal Society of Chemistry
Total Pages: 272
Release: 2016-03-08
Genre: Science
ISBN: 1782625941

Pharmaceutical manufacturing was one of the first industries to recognize the importance of green chemistry, with pioneering work including green chemistry metrics and alternative solvents and reagents. Today, other topical factors also have to be taken into consideration, such as rapidly depleting resources, high energy costs and new legislation. This book addresses current challenges in modern green chemical technologies and sustainability thinking. It encompasses a broad range of topics covered by the CHEM21 project – Europe’s largest public-private partnership project which aims to develop a toolbox of sustainable technologies for green chemical intermediate manufacture. Divided into two sections, the book first gives an overview of the key green chemistry tools, guidance and considerations aimed at developing greener processes, before moving on to look at cutting-edge synthetic methodologies. Featuring innovative research, this book is an invaluable reference for chemists across academia and industry wanting to further their knowledge and understanding of this important topic.

Clinical Trial Simulations

Clinical Trial Simulations
Author: Holly H. C. Kimko
Publisher: Springer Science & Business Media
Total Pages: 540
Release: 2010-12-09
Genre: Medical
ISBN: 1441974156

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

Antibody-Drug Conjugates

Antibody-Drug Conjugates
Author: Jeffrey Wang
Publisher: Springer
Total Pages: 248
Release: 2015-03-05
Genre: Medical
ISBN: 3319130811

This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.

Mixed Effects Models for the Population Approach

Mixed Effects Models for the Population Approach
Author: Marc Lavielle
Publisher: CRC Press
Total Pages: 380
Release: 2014-07-14
Genre: Mathematics
ISBN: 1482226510

Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects ModelsMixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whol

Podocytopathy

Podocytopathy
Author: Z.-H. Liui
Publisher: Karger Medical and Scientific Publishers
Total Pages: 274
Release: 2014-05-16
Genre: Science
ISBN: 3318026514

The podocyte is a key cell that forms the last barrier of the kidney filtration unit. One of the most exciting developments in the field of nephrology in the last decade has been the elucidation of its biology and its role in the pathophysiology of inherited and acquired glomerular disease, termed podocytopathy. In this publication, world-renowned experts summarize the most recent findings and advances in the field: they describe the unique biological features and injury mechanisms of the podocyte, novel techniques used in their study, and diagnosis and potential therapeutic approaches to glomerular diseases. Due to its broad scope, this publication is of great value not only for clinical nephrologists and researchers, but also for students, residents, fellows, and postdocs.