Erschienen: 29.03.2019 Abbildung von Hasnain | Pharmaceutical Quality by Design | 2019 | Principles and Applications

Hasnain

Pharmaceutical Quality by Design

Principles and Applications

lieferbar, ca. 4 Wochen

ca. 187,25 €

inkl. Mwst.

2019. Buch. 448 S. Softcover

William Andrew Publishing. ISBN 978-0-12-815799-2

Format (B x L): 15,2 x 22,9 cm

In englischer Sprache

Produktbeschreibung

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials.

Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.



- Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries
- Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers
- Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Gesamtwerk

Die 8. Auflage ist wieder auf sechs Bände angelegt. Darin finden sich übersichtlich und in systematischer Gliederung Vertragsmuster aus der Feder erfahrener Experten. Jedem dieser Muster folgen Anmerkungen, mit denen der dem Vertragsentwurf zu Grunde liegende Sachverhalt und die Gründe für die Wahl des spezifischen Formulars erläutert werden.

Autoren

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