Quality by Design for Biopharmaceutical Drug Product Development

• Corporate Author: SpringerLink (Online service)
• Other Authors: Jameel, Feroz (Editor), Hershenson, Susan (Editor), Khan, Mansoor A. (Editor), Martin-Moe, Sheryl (Editor)
• Format: Electronic eBook
• Language: English
• Published: New York, NY : Springer New York : Imprint: Springer, 2015.
• Series: AAPS Advances in the Pharmaceutical Sciences Series, 18
• Subjects: Medicine.; Pharmacology.; Biomedicine.; Pharmacology/Toxicology.; Biomedicine general.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these element...