Benefit-Risk Assessment in Pharmaceutical Research and Development, Sashegyi, Andreas
Автор: Shah B. Название: Textbook Of Pharmacognosy And Phytochemistry 2Ed ISBN: 9386217732 ISBN-13(EAN): 9789386217738 Издательство: CBS India Рейтинг: Цена: 36580.00 T Наличие на складе: Есть
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
Discusses the development of strategy blueprints in the design of continuous processes
Shows how to create process flowsheet models from individual unit operation models
Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
Covers the evolving regulatory expectations for continuous manufacturing
Provides readers with ways to more effectively navigate these expectations
Автор: Anya Hillery Название: Drug Delivery ISBN: 1138407364 ISBN-13(EAN): 9781138407367 Издательство: Taylor&Francis Рейтинг: Цена: 193950.00 T Наличие на складе: Невозможна поставка. Описание: This book provides a comprehensive introduction to advanced drug delivery and targeting, covering their principles, current applications, and potential future developments
Автор: Chin, Richard Название: Adaptive and Flexible Clinical Trials ISBN: 0367382474 ISBN-13(EAN): 9780367382476 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon.
Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.
Автор: Pal Dilipkumar, Nayak Amit Kumar Название: Bioactive Natural Products for Pharmaceutical Applications ISBN: 303054026X ISBN-13(EAN): 9783030540265 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book covers the recent innovations relating to various bioactive natural products (such as alkaloids, glycosides, flavonoids, anthraquinones, steroids, polysaccharides, tannins and polyphenolic compounds, volatile oils, fixed oils, fats and waxes, proteins and peptides, vitamins, marine products, camptothecin, piperines, carvacrol, gedunin, GABA, ginsenosides) and their applications in the pharmaceutical fields related to academic, research and industry.
Автор: Pal Dilipkumar, Nayak Amit Kumar Название: Bioactive Natural Products for Pharmaceutical Applications ISBN: 3030540294 ISBN-13(EAN): 9783030540296 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: An introduction to bioactive natural products.- Importance of natural products.- Secondary Metabolites from Plant Sources.- Nutraceuticals.- Natural Polymers.- Marine Products.- Proteins and Enzymes.- Vitamins.- Natural Fibres.- Cosmetics from Plant Origin.
Автор: Astrid Sigel, Eva Freisinger, Roland K.O. Sigel Название: Metal Ions in Bio-Imaging Techniques ISBN: 3110685566 ISBN-13(EAN): 9783110685565 Издательство: Walter de Gruyter Рейтинг: Цена: 285130.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Volume 22, entitled Metal Ions in Bio-Imaging Techniques, of the series Metal Ions in Life Sciences deals with metal ions as tools in imaging. This dates back to the first half of the past century, when barium sulfate was orally given to patients undergoing X-ray examination. The use of contrast agents has since developed into a large interdisciplinary field encompassing not only medicine, but also chemistry, material sciences, physics, biology, engineering, and computer sciences. MILS-22 provides deep and current insights in 17 stimulating chapters on the new research frontiers of this fast growing field on bio-imaging ... and beyond. For example, adding bio-sensing yields theranostic agents, meaning diagnosis and therapy linked in the same molecule; ions of Gd, Mn, Fe, Co, Ir, 99mTc, etc., are involved. Other important topics are, e.g., metal complexes in paramagnetic Chemical Exchange Transfer (paraCEST), radiometals for Positron Emission Tomography (PET) imaging, or paramagnetic metal ion probes for 19F magnetic resonance imaging. MILS-22 is written by 57 internationally recognized experts from 12 countries, that is, from the US via Europe to China. The impact of this vibrant research area is manifested by more than 2300 references and nearly 120 figures, mostly in color, and several informative tables. To conclude, Metal Ions in Bio-Imaging Techniques is an essential resource for scientists working in the wide range from material sciences, enzymology, analytic, organic, and inorganic biochemistry all the way through to medicine including the clinic ... not forgetting that also excellent information for teaching is provided.
Автор: Amit Singh Название: Stimuli-Responsive Drug Delivery Systems ISBN: 1788011139 ISBN-13(EAN): 9781788011136 Издательство: Royal Society of Chemistry Рейтинг: Цена: 223870.00 T Наличие на складе: Нет в наличии. Описание: This book provides a comprehensive account on the design, materials chemistry, and application aspects behind these novel stimuli-responsive materials.
Автор: Talevi Alan, Quiroga Pablo A. M. Название: Adme Processes in Pharmaceutical Sciences: Dosage, Design, and Pharmacotherapy Success ISBN: 3319995928 ISBN-13(EAN): 9783319995922 Издательство: Springer Рейтинг: Цена: 111790.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Absorption, Distribution, Metabolism and Excretion (ADME) processes and their relationship with the design of dosage forms and the success of pharmacotherapy form the basis of this upper level undergraduate/graduate textbook. As an introduction oriented to pharmacy students, it is also written for scientist from different fields outside of pharmaceutics. (e.g. material scientist, material engineers, medicinal chemists) who might be working in a positions in pharmaceutical companies or whose work might benefit from basic training in the ADME concepts and some biological background. Pedagogical features such as objectives, keywords, discussion questions, summaries and case studies add valuable teaching tools. This book will provide not only general knowledge on ADME processes but also an updated insight on some hot topics such as drug transporters, multi-drug resistance related to pharmacokinetic phenomena, last generation pharmaceutical carriers (nanopharmaceuticals), in vitro and in vivo bioequivalence studies, biopharmaceuticals, pharmacogenomics, drug-drug and food-drug interactions, and in silico and in vitro prediction of ADME properties. In comparison with other similar textbooks, around half of the volume would be focused on the relationship between expanding scientific fields and ADME processes. Each of these burgeoning fields has a separate chapter in the second part of the volume, and was written with leading experts on the correspondent topic, including scientists and academics from USA and UK (Duquesne University School of Pharmacy, Indiana University School of Medicine, University of Utah College of Pharmacy, University of Maryland, University of Bath).Additionally, each of the initial chapters dealing with the generalities of drug absorption, distribution, metabolism and excretion would include relevant, classic examples related to each topic with appropriate illustrations (e.g. importance of active absorption of levodopa, implications in levodopa administration, drug drug interactions and food drug interactions emerging from the active uptake; intoxication with paracetamol as a result of glutathione depletion, CYP induction and its relationship with acute liver failure caused by paracetamol, etc).ADME Processes and Pharmaceutical Sciences is written as a core textbook for ADME processes, pharmacy, pharmacokinetics, drug delivery, biopharmaceutics, drug disposition, drug design and medicinal chemistry courses.
Автор: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493955586 ISBN-13(EAN): 9781493955589 Издательство: Springer Рейтинг: Цена: 130430.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
.- 1 Bioequivalence History
.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu
.- 2 Fundamentals of Bioequivalence
.- Mei-Ling Chen
.- 3 Basic Statistical Considerations
.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann
.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence
.- Wayne I. DeHaven and Dale P. Conner
.- 5 Biowaiver and Biopharmaceutics Classification System
.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu
.- 6 Bioequivalence of Highly Variable Drugs
.- Barbara M. Davit and Devvrat T. Patel
.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu
.- 8 Bioequivalence for Narrow Therapeutic Index Drugs
.- Nan Zheng, Wenlei Jiang, Robert Lionberger, and Lawrence X. Yu
.- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract
.- Xiaojian Jiang, Yongsheng Yang, and Ethan Stier
.- 13 Bioequivalence for Topical Drug Products
.- April C. Braddy and Dale P. Conner
.- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products
.- Bhawana Saluja, Bing V. Li and Sau L. Lee
.- 15 Bioequivalence: Modeling and Simulation
.- Xinyuan Zhang and Robert Lionberger
.- 16 Bioanalysis
.- Sriram Subramaniam.
Автор: Guy Wingate, Glaxo Smith Kline, Durham, UK Название: Pharmaceutical Computer Systems Validation ISBN: 1420088947 ISBN-13(EAN): 9781420088946 Издательство: Taylor&Francis Рейтинг: Цена: 193950.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Pharmaceutical Computer Systems Validation
Автор: Brahmachari Название: Handbook of Pharmaceutical Natural Products : Wiley.- ISBN 9783527321483 СОЕДИНЕННОЕ КОРОЛЕВСТВО ISBN: 3527321489 ISBN-13(EAN): 9783527321483 Издательство: Wiley Рейтинг: Цена: 387500.00 T Наличие на складе: Поставка под заказ. Описание: In a classical alphabetical format, this two-volume reference covers more than 1000 painstakingly screened natural product structures. For each compound or compound class, a basic chemical characterization is given, followed by a description of the biological source and a discussion of their pharmaceutical potential as lead molecules for new drugs.
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