Найти книгу: "Bioequivalence Studies in Drug Development"

Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Bioequivalence Studies in Drug Development is written in an accessible style that makes it ideal for pharmaceutical scientists, clinical pharmacologists, and medical practitioners, as well as biometricians working in the pharmaceutical industry. It will also be of great value for professionals from regulatory bodies assessing bioequivalence studies.

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.

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.

Методическое пособие разработано преподавателями кафедры английского языка факультета экономики НИУ ВШЭ в ходе занятий со студентами по учебнику «English for Business Studies» Издательства Кембриджского университета (Cambridge University Press). Цель создания пособия – дополнить существующий курс упражнениями и заданиями на перевод, грамматическими упражнениями, а также глоссарием с русскоязычными соответствиями. Пособие рекомендуется как дополнительный компонент к учебному курсу «English for Business Studies» (3-е изд.) для российских студентов-экономистов.

‘Academic Skills through Cases in American Studies’ is aimed at ESL college students at the Intermediate-high through Advanced levels of language proficiency. It is designed around eight country-specific (U.S.) cases that develop academic skills tested on international exams. The book covers major topics in the areas of academic reading, speaking and writing. Thus, the targeted learning outcome is two-fold: 1) to explore topical issues in American studies and 2) to master key academic skills. The content of the articles in each unit is selected according to the language needs of students majoring in economics, sociology, political science, and the like. The book can be used both as a supplement to a course in American Studies or as a separate curriculum within an academic skills course.