Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing - Couverture souple

Yang, Harry

Couverture souple

ISBN 10 : 0367736640 ISBN 13 : 9780367736644

Editeur : Routledge, 2020

Synopsis

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

A propos du livre

À propos de l'auteur

Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

Détails de l'édition

• Éditeur: Routledge
• Date d'édition: 2020
• Langue: anglais
• ISBN 10: 0367736640
• ISBN 13: 9780367736644
• Reliure: Broché
• Nombre de pages: 386
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible