Название: Real-World Evidence in Drug Development and Evaluation ISBN: 036702621X ISBN-13(EAN): 9780367026219 Издательство: Taylor&Francis Рейтинг: Цена: 19906.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are healthcare data that are collected outside the constraints of conventual controlled randomized trials (CRTs); whereas RWE is the knowledge derived from aggregation and analysis of RWD.
Название: Anticancer Agents: Design, Synthesis and Evaluation ISBN: 3036501401 ISBN-13(EAN): 9783036501406 Издательство: Неизвестно Рейтинг: Цена: 22056.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This book is a printed edition of the Special Issue entitled "Anticancer Agents: Design, Synthesis and Evaluation" that was published in Molecules. Two review articles and thirty research papers are included in the Special Issue. Three second-generation androgen receptor antagonists that have been approved by the U.S. FDA for the treatment of prostate cancer have been reviewed. Identification of mimics of protein partners as protein-protein interaction inhibitors via virtual screening has been summarized and discussed. Anticancer agents targeting various protein targets, including IGF-1R, Src, protein kinase, aromatase, HDAC, PARP, Toll-Like receptor, c-Met, PI3Kdelta, topoisomerase II, p53, and indoleamine 2,3-dioxygenase, have been explored. The analogs of three well-known tubulin-interacting natural products, paclitaxel, zampanolide, and colchicine, have been designed, synthesized, and evaluated. Several anticancer agents representing diverse chemical scaffolds were assessed in different kinds of cancer cell models. The capability of some anticancer agents to overcome the resistance to currently available drugs was also studied. In addition to looking into the in vitro ability of the anticancer agents to inhibit cancer cell proliferation, apoptosis, and cell cycle, in vivo antitumor efficacy in animal models and DFT were also investigated in some papers.
Автор: Shayne C. Gad Название: Safety Evaluation of Pharmaceuticals and Medical Devices ISBN: 148998187X ISBN-13(EAN): 9781489981875 Издательство: Springer Рейтинг: Цена: 19589.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The inspiration for this text was the 1988 volume by Alder and Zbinden. Since then, much has changed. But the intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man.
Автор: A.N. Worden; D.V. Parke; J. Marks Название: The Future of Predictive Safety Evaluation ISBN: 9401079366 ISBN-13(EAN): 9789401079365 Издательство: Springer Рейтинг: Цена: 12157.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents.
Автор: Perovitch, Milosh Название: Radiological Evaluation Of The Spinal Cord ISBN: 0367260867 ISBN-13(EAN): 9780367260866 Издательство: Taylor&Francis Рейтинг: Цена: 22968.00 р. Наличие на складе: Поставка под заказ.
Описание: First Published in 1989, this book explores the relationship between plants and insects and the ways in which they interact with each other. Carefully compiled and filled with a vast repertoire of notes, diagrams, and references this book serves as a useful reference for students of oncology, and other practitioners in their respective fields.
Описание: Evaluation for Health Policy and Health Care: A Contemporary Data-Driven Approach explores the best practices and applications for producing, synthesizing, visualizing, using, and disseminating health care evaluation research and reports.
Автор: Gerald P?ch Название: Combined Effects of Drugs and Toxic Agents ISBN: 3211824340 ISBN-13(EAN): 9783211824344 Издательство: Springer Рейтинг: Цена: 12157.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Scientists struggling with the pharmaco- and toxicodynamic interactions of drugs and chemicals will find this book a valuable reference to the relevant theoretical background of this complex field and an indispensible guide to practical, analytical procedures for evaluation of experimental data.
Автор: Mukherjee, Pulok K. Название: Quality Control and Evaluation of Herbal Drugs ISBN: 0128133740 ISBN-13(EAN): 9780128133743 Издательство: Elsevier Science Рейтинг: Цена: 39582.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Quality Control and Evaluation of Herbal Drugs brings together current thinking and practice for evaluation of natural products and traditional medicines. The use of herbal medicine in therapeutics is on the rise in both developed and developing countries and this book facilitates the necessary development of quality standards for these medicines.This book elucidates on various challenges and opportunities for quality evaluation of herbal drugs with several integrated approaches including metabolomics, chemoprofiling, marker analysis, stability testing, good practices for manufacturing, clinical aspects, Ethnopharmacology and Ethnomedicine inspired drug development.
Written by Prof. Pulok K Mukherjee, a leader in this field; the book highlights on various methods, techniques and approaches for evaluating the purity, quality, safety and efficacy of herbal drugs. Particular attention is paid to methods that assess these drugs' activity, the compounds responsible and their underlying mechanisms of action. The book describes the quality control parameters followed in India and other countries, including Japan, China, Bangladesh, and other Asian countries, as well as the regulatory profiles of the European Union and North America. This book will be useful in bio-prospecting of natural products and traditional medicine-inspired drug discovery and development.
Provides new information on the research and development of natural remedies - essential reading on the study and use of natural resources for preventative or healing purposes
Brings together current thinking and practices in quality control and standardization of herbal drugs highlighting several integrated approaches for metabolomics, chemo-profiling and marker analysis.
Aids in developing knowledge of various techniques including macroscopy, microscopy, HPTLC, HPLC, LC-MS/MS, GC-MS etc. with the development of integrated methods for evaluation of botanicals used in traditional medicine.
Assessment of herbal drugs through bio-analytical techniques, bioassay guided isolation, enzyme inhibition, pharmacological, microbiological, antiviral assays and safety related quality issues.
References global organizations, such as the WHO, USFDA, CDSCO, AYUSH, TCM and others to serve as a comprehensive document for enforcement agencies, NGOs and regulatory authorities.
Автор: Khan, Iftekhar Название: Economic Evaluation of Cancer Drugs ISBN: 0367727072 ISBN-13(EAN): 9780367727079 Издательство: Taylor&Francis Рейтинг: Цена: 7501.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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.
Автор: Jean-Charles Gautier Название: Drug Safety Evaluation ISBN: 1493956698 ISBN-13(EAN): 9781493956692 Издательство: Springer Рейтинг: Цена: 20263.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies.
Автор: Jean-Charles Gautier Название: Drug Safety Evaluation ISBN: 1493971700 ISBN-13(EAN): 9781493971701 Издательство: Springer Рейтинг: Цена: 20962.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Part I: General Toxicology
1. Nonclinical Development of Combination Drugs
Alberto Lodola
2. Juvenile Non-Clinical Safety Studies in Support of Pediatric Drug Development
Paul C. Barrow and Georg Schmitt
Part II: Pathology
3. Procedures of Necropsy and Tissue Sampling
Laurence Fiette, Mohamed Slaoui, and Anne-Laure Bauchet
4. Tissue Sampling and Processing for Histopathology Evaluation
Mohamed Slaoui, Anne-Laure Bauchet, and Laurence Fiette
5. Principles and Methods of Immunohistochemistry
Josй A. Ramos-Vara
6. Applications of Mass Spectrometry Imaging for Safety Evaluation
David Bonnel and Jonathan Stauber
Part III Genetic Toxicology
7. In vivo rat T-lymphocyte Pig-a assay: detection and expansion of cells deficient in the GPI-anchored CD48 surface marker for analysis of mutation in the endogenous Pig-a gene
Vasily N Dobrovolsky, Javier Revollo, Dayton M Petibone, and Robert H Heflich
8. Detection of In Vivo Mutation in the Pig-a Gene of Mouse Bone Marrow Erythroids
Takafumi Kimoto and Daishiro Miura
9. The Use of Bacterial Repair Endonucleases in the Comet Assay
Andrew R. Collins
Part IV Safety Pharmacology
10. Automated Patch-Clamp methods for the hERG Cardiac Potassium Channel
Sylvie Houtmann, Brigitte Schombert, Camille Sanson, Michel Partiseti, and G. Andrees Bohme
11. Impedance Measurement in Induced Pluripotent Stem Cell Derived Cardiomyocytes
Emma-Jane Poulton
Part V Investigative Toxicology
12. Target Safety Assessment: Strategies and Resources
Richard J. Brennan
13. NMR and MS Methods for Metabolomics
Alexander Amberg, Bjцrn Riefke, Gцtz Schlotterbeck, Alfred Ross, Hans Senn, Frank Dieterle, and Matthias Keck
14. Protocols and Applications of Cellular Metabolomics in Safety Studies Using
Precision-Cut Tissue Slices and Carbon 13 NMR
Gabriel Baverel, Maha El Hage, and Guy Martin
15. Statistical Analysis of Quantitative RT-PCR Results
Richard Khan-Malek and Ying Wang
16. Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes
Jean-Pierre Marchandeau and Gilles Labbe
Part VI Screening Assays for Developmental Toxicity
17. FETAX Assay for Evaluation of Developmental Toxicity
Isabelle Mouche, Laure Malйsic, and Olivier Gillardeaux
18. Evaluation of Embryotoxicity Using
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