Найти книгу: "Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture"

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

While the success of Open Source software like Linux or Apache has been documented extensively throughout all mainstream media, the rise of PHP has gone largely unnoticed. Still, the Web scripting language PHP is the most popular module for the Apache Web server, according to an E-Soft survey (www.e-softinc.com/survey/). Netcraft studies have found that PHP is in use on over 6% of all Web domains in the world (see www.netcraft.com/survey).That’s an incredible market penetration for a rather specialized product.This popularity continues to rise exponentially. Increasingly, this is being reflected in traditional media: As of May, 2000, more than 20 books about PHP have been published in different languages, with more in the pipeline. Commercial players are beginning to join the bandwagon: PHP is included with Web servers, for example C2’s Stronghold, and Linux distributions. A new company, Zend Technologies, has been formed to provide commercial add-ons and support for PHP.A long list of large-scale Web sites employ PHP, as well as hundreds of thousands of small to medium Web sites.

Более 350 кельтских орнаментов в виде схем для вышивки крестом (и других счетных техник рукоделия). Книга просто уникальная для всех любителей кельтского орнамента и любителей рукоделия. Уровень предложенных орнаментов - от простейших "косичек" до сложных "ковровых" рисунков. Короткий пояснительный текст на английском относится, главным образом, к технике вышивки. Все схемы даны в ч/б варианте, клетка очень мелкая но хорошо различимая.

The personal home page (PHP) server-side scripting language is particular well adapted to connecting HTML-based web pages to a backend database for dynamic content. This book explains the entire nuts-and-bolts process of the PHP application life cycle: requirements, design, development, maintenance and tuning. It shows how PHP can be used to design and develop highly manageable and secure applications to solve practical problems.

Written by members of the Oracle XML group, this is a must-have reference for all IT managers, DBAs, and developers who want to learn the best practices for using XML with Oracle’s XML-enabled products. Includes real-world case studies based on theauthors’ experience managing Oracle’s XML Discussion Forum - a community of 20,000+ XML component users.