Quality by Design for Biopharmaceutical Drug Product Development (AAPS Advances in the Pharmaceutical Sciences Series)
| Author | : | |
| Rating | : | 4.84 (595 Votes) |
| Asin | : | 1493923153 |
| Format Type | : | paperback |
| Number of Pages | : | 710 Pages |
| Publish Date | : | 2014-11-12 |
| Language | : | English |
DESCRIPTION:
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 elements are integrated into drug product development. This includes the use of QbD in primary containers, devices and combination product development. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.Later chapters describe more specialized applications of QbD in the drug product realm. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.. These chapters also dis
Later chapters describe more specialized applications of QbD in the drug product realm. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. This includes the use of QbD in primary containers, devices and combination product development. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. It concludes with a discussion on
I only recommended for such purpose This a very specific book for biologic in a biotech industry. I only recommended for such purpose. If you work on a solid dosage, aerosol, or transdermal industry it may not be a good source. There are other books online like: Design for Six Sigma by Kai Yang that might be more appropiate to reference.
She worked at Sterling Drug in its research division and held management positions in various Development and Operation areas at Centocor, Bayer, and Genentech and was most recently Global Head of Pharmaceutical Development at Novartis Biologics in Basel, Switzerland. Feroz Jameel is a Principal Scientist for Parenteral Product & Process Development at Amgen Inc.,