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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 elements are integrated into
drug product development. These chapters also discuss lessons
learned from the FDA Office of Biotechnology Products pilot
program. 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. 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. This includes the
use of QbD in primary containers, devices and combination product
development. The volume also explores QbD applied to vaccine
development, automation, mathematical modeling and monitoring, and
controlling processes and defining control strategies. 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.
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 elements are integrated into
drug product development. These chapters also discuss lessons
learned from the FDA Office of Biotechnology Products pilot
program. 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. 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. This includes the
use of QbD in primary containers, devices and combination product
development. The volume also explores QbD applied to vaccine
development, automation, mathematical modeling and monitoring, and
controlling processes and defining control strategies. 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.
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