The use of modeling and simulation tools is rapidly gaining
prominence in the pharmaceutical industry covering a wide range of
applications. This book focuses on modeling and simulation tools as
they pertain to drug product manufacturing processes, although
similar principles and tools may apply to many other areas.
Modeling tools can improve fundamental process understanding and
provide valuable insights into the manufacturing processes, which
can result in significant process improvements and cost savings.
With FDA mandating the use of Quality by Design (QbD) principles
during manufacturing, reliable modeling techniques can help to
alleviate the costs associated with such efforts, and be used to
create in silico formulation and process design space. This book is
geared toward detailing modeling techniques that are utilized for
the various unit operations during drug product manufacturing. By
way of examples that include case studies, various modeling
principles are explained for the nonexpert end users. A discussion
on the role of modeling in quality risk management for
manufacturing and application of modeling for continuous
manufacturing and biologics is also included.
General
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