Описание: High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.
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: Center For Chemical Process Safety (ccps) Название: Layer of protection analysis ISBN: 0816908117 ISBN-13(EAN): 9780816908110 Издательство: Wiley Рейтинг: Цена: 29930.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book explores the many different strands in the language of civil society from the sixteenth to the twentieth centuries. Through a series of case-studies it investigates the applicability of the term to a wide range of historical settings. The contributors show how past understandings of the term were often very different from (even in some respects the exact opposite of) those held today.
Автор: Basu, Swapan Название: Plant Hazard Analysis and Safety Instrumentation Systems ISBN: 0128037636 ISBN-13(EAN): 9780128037638 Издательство: Elsevier Science Рейтинг: Цена: 23244.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Plant Hazard Analysis and Safety Instrumentation Systems is the first book to combine coverage of these two integral aspects of running a chemical processing plant. It helps engineers from various disciplines learn how various analysis techniques, international standards, and instrumentation and controls provide layers of protection for basic process control systems, and how, as a result, overall system reliability, availability, dependability, and maintainability can be increased.
This step-by-step guide takes readers through the development of safety instrumented systems, also including discussions on cost impact, basics of statistics, and reliability. Swapan Basu brings more than 35 years of industrial experience to this book, using practical examples to demonstrate concepts.
Basu links between the SIS requirements and process hazard analysis in order to complete SIS lifecycle implementation and covers safety analysis and realization in control systems, with up-to-date descriptions of modern concepts, such as SIL, SIS, and Fault Tolerance to name a few. In addition, the book addresses security issues that are particularly important for the programmable systems in modern plants, and discusses, at length, hazardous atmospheres and their impact on electrical enclosures and the use of IS circuits.
Автор: Janzen Название: High Throughput Screening ISBN: 1493936719 ISBN-13(EAN): 9781493936717 Издательство: Springer Рейтинг: Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This third edition volumeexpands on the previous editions both by presenting more detailed protocols forthe techniques described in the first and second editions of High ThroughputScreening: Methods and Protocolsand by covering important new procedures. The first chapter ofthis book provides an overview of important assay development techniques, whilethe rest of the chapters detail how to develop and execute screens at whateverthroughput the user needs. Some chapter examples are: structure-based virtualscreening, high throughput screening using mass spectrometry, identification of state-dependentblockers for voltage gated calcium channels, bioluminescence resonanceenergy transfer platform to monitor protein-protein interactions in live cells,high throughput flow cytometry, and application of imaging-based assays in microplate formats for highcontent screening. Written in the highly successful Methods in MolecularBiology series format, chapters include introductions to their respectivetopics, lists of the necessary materials and reagents, step-by-step, readilyreproducible laboratory protocols, and tips on troubleshooting and avoidingknown pitfalls.Cutting edge and thorough, High Throughput Screening: Methods and Protocols,Third Edition, is a valuable resource for anyone who is interested in HTSresearch.
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