W. Schlindwein – Pharmaceutical Quality by Design (2018)

Автор: W. Schlindwein
Название книги: Pharmaceutical Quality by Design (2018)
Формат: PDF
Тема: Фармацевтическое качество
Страницы: 365
Качество: Изначально компьютерное, E-book

Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product.

Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource:

Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development
Puts the focus on the industrial aspects of the new QbD approach
Includes several illustrative examples of applications of QbD in practice
Offers advanced specialist topics that can be systematically applied to industry