Quantitative decisions in drug development, Chuang-stein, Christy Kirby, Simon
Автор: Chuang-Stein Christy, Kirby Simon Название: Quantitative Decisions in Drug Development ISBN: 3319834347 ISBN-13(EAN): 9783319834344 Издательство: Springer Рейтинг: Цена: 9083.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Clinical Testing of a New Drug.- A Frequentist Decision-making Framework.- Characteristics of a Diagnostic Test.- The Parallel Between Clinical Trials and Diagnostic Tests.- Incorporating Information from Completed Trials in Future Trial Planning.- Choosing Metrics Appropriate for Different Stages of Drug Development.- Designing Proof-of-Concept Trials with Desired Characteristics.- Designing Dose-response Studies with Desired Characteristics.- Designing Confirmatory Trials with Desired Characteristics.- Designing Phase 4 Trials.- Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.- Discounting Prior Results to Account for Selection Bias.- Index.- Appendix.
Автор: Dominique Gu?gan; Bertrand K. Hassani Название: Risk Measurement ISBN: 3030026795 ISBN-13(EAN): 9783030026790 Издательство: Springer Рейтинг: Цена: 11878.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book combines theory and practice to analyze risk measurement from different points of view. The limitations of a model depend on the framework on which it has been built as well as specific assumptions, and risk managers need to be aware of these when assessing risks. The authors investigate the impact of these limitations, propose an alternative way of thinking that challenges traditional assumptions, and also provide novel solutions. Starting with the traditional Value at Risk (VaR) model and its limitations, the book discusses concepts like the expected shortfall, the spectral measure, the use of the spectrum, and the distortion risk measures from both a univariate and a multivariate perspective.
State-of-the-Art Methods for Drug Safety Assessment
Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment.
The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.
Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Описание: "This book discusses recent advancements in the field of QSARs with special reference to their application in drug development, predictive toxicology, and chemical risk analysis"--Provided by publisher.
Автор: Martin, Yvonne C. Название: Quantitative Drug Design ISBN: 0367384140 ISBN-13(EAN): 9780367384142 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Since the publication of the first edition, the field has changed dramatically. Scientists can now explicitly consider 3D features in quantitative structure-activity relationship (QSAR) studies and often have the 3D structure of the macromolecular target to guide the 3D QSAR. Improvements in computer hardware and software have also made the methods more accessible to scientists. Taking these developments into account, Quantitative Drug Design: A Critical Introduction, Second Edition shows scientists how to apply QSAR techniques at a state-of-the-art level.
New to the Second Edition
A new chapter on methods that identify the 3D conformations to use for 3D QSAR
New discussions on partial least squares, multidimensional scaling, clustering, support vector machines, kNN potency prediction, and recursive partitioning
Expanded case studies that include the results of data that has been re-analyzed using newer methods
A new case study on the discovery of novel dopaminergics with pharmacophore mapping and CoMFA
A new case study on the application of CoMFA to series in which the 3D structure of the ligand-protein complex is known
Based on the author's four decades of experience in all areas of ligand-based computer-assisted drug design, this invaluable book describes how to transform ligand structure-activity relationships into models that predict the potency or activity/inactivity of new molecules. It will help you avoid traps when dealing with quantitative drug design.
Описание: This unique text helps students and healthcare professionals master the fundamentals of pharmacokinetics and pharmacodynamics. Written by distinguished international experts, it provides readers with an introduction to the basic principles underlying the establishment and individualization of dosage regimens and their optimal use in drug therapy. Up-to-date examples featuring currently prescribed drugs illustrate how pharmacokinetics and pharmacodynamics relate to contemporary drug therapy. Study problems at the end of each chapter help students and professionals gain a firm grasp of the material covered within the text.
Описание: This thorough book explores some of the most important methods and concepts affecting the quantitative analysis of the transport, targeting, and disposition of chemicals within cells, which in turn impact the macroscopic pharmacokinetics of chemical agents in the whole organism. The first half of the volume focuses on small organic molecules with drug-like characteristics, while the second half delves into the cellular pharmacokinetics of biologics and other macromolecules, including peptide therapeutics, cyclotides, antibodies, as well as nanoparticles, thus creating a comprehensive treatise that approaches cellular pharmacokinetics from the different perspectives of pharmaceutical scientists, chemical biologists, medicinal chemists, and protein engineers dealing with very different chemical agents spanning a wide range of sizes, physicochemical properties, and targeting mechanisms. Written for the Methods in Pharmacology and Toxicology series, chapters provide the kind of key detail and expert implementation advice that leads to excellent results in the lab. Synthetic biologists, biophysicists, and bioengineers are amongst the long list of scientists who could benefit from reading this book or from using it as a textbook. Authoritative and practical, Quantitative Analysis of Cellular Drug Transport, Disposition, and Delivery builds on a long history of drug development and the adding of quantitative methods at the cellular scale in order to inspire new approaches to drug development that are better able to take advantage of phenomena such as soluble-to-insoluble phase transitions or bispecific targeting, which could ultimately be exploited for the development of more effective drug delivery systems and therapeutic agents.
Автор: Hugo Kubinyi; Gerd Folkers; Yvonne C. Martin Название: 3D QSAR in Drug Design ISBN: 0792347919 ISBN-13(EAN): 9780792347910 Издательство: Springer Рейтинг: Цена: 39182.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Significant progress has been made in the study of three-dimensional quantitative structure-activity relationships (3D QSAR) since the first publication by Richard Cramer in 1988 and the first volume in the series, 3D QSAR in Drug Design.
Автор: R.B. Barlow Название: Quantitative Aspects of Chemical Pharmacology ISBN: 0709903006 ISBN-13(EAN): 9780709903000 Издательство: Springer Рейтинг: Цена: 12157.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
1. Measurement of Transcellular Transport Rates and Intracellular Drug Sequestration in the Presence of an Extracellular Concentration Gradient
Kyoung Ah Min and Gus R. Rosania
2. Kinetic Design for Establishing Long Term Stationary Cytosol Concentrations during Drug Transport across P-gp Expressing Confluent Cell Monolayers to Facilitate Measuring Cytosol Concentration, Fitting Drug Molar Partition Coefficients into the Cytosolic Monolayer of the Plasma Membrane and Kinetically Identifying Drug Uptake Transporters
Joe Bentz
3. In Vitro Methodologies to Assess Potential for Transporter-Mediated Drug-Drug Interactions
Jibin Li, Qing Wang, and Ismael J. Hidalgo
4. Determination of Fraction Unbound and Unbound Partition Coefficient to Estimate Intracellular Free Drug Concentration
Sangwoo Ryu, Keith Riccardi, Samantha Jordan, Nathaniel Johnson, and Li Di
5. Quantitative Analysis of Intracellular Drug Concentrations in Hepatocytes
Chitra Saran, James J. Beaudoin, Nathan D. Pfeifer, and Kim L.R. Brouwer
6. Quantification of Intracellular Drug Aggregates and Precipitates
Phillip Rzeczycki and Gus R. Rosania
7. Quantitative Phenotypic Analysis of Drug Sequestering Macrophage Subpopulations
Mikhail D. Murashov
8. Using an Integrated QSAR Model to Check Whether Small-Molecule Xenobiotics Will Accumulate in Biomembranes, with Particular Reference to Fluorescent Imaging Probes
Richard W. Horobin and Juan C. Stockert
9. Diversity-Oriented Fluorescence Library Approach (DOFLA) for Discovery of Cell-Permeable Probes for Applications in Live Cell Imaging
Dongdong Su and Young-Tae Chang
Part II: Macromolecules, Biologics, and Nanoparticles
10. Overcoming Cellular and Systemic Barriers to Design the Next Wave of Peptide Therapeutics
Jerome Hochman, Tomi Sawyer, and Ruchia Duggal
11. Intracellular Targeting of Cyclotides for Therapeutic Applications
Nicole Lawrence and David J. Craik
12. Cellular Trafficking of Monoclonal and Bispecific Antibodies
John J. Rhoden and Christopher M. Wiethoff
13. Quantitative Drug Target Imaging Using Paired-Agent Principles
Kenneth M. Tichauer, Negar Sadeghipour, Yu "Winston" Wang, Summer L. Gibbs, Jonathan T.C. Liu, and Kimberley S. Samkoe
14. Quantitative Determination of Intracellular Bond Cleavage
Joshua A. Walker, Michelle R. Sorkin, and Christopher A. Alabi
15. Development and Application of a Single Cell-Level PK-PD Model for ADCs
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Автор: Jiang, Qi Название: Quantitative Evaluation of Safety in Drug Development ISBN: 0367576007 ISBN-13(EAN): 9780367576004 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Поставка под заказ.
Автор: Martin, Yvonne C. Название: Quantitative Drug Design ISBN: 1420070991 ISBN-13(EAN): 9781420070996 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Поставка под заказ.
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