Description: 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.
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EAN: 9780081001547
UPC: 9780081001547
ISBN: 9780081001547
MPN: N/A
Item Length: 23.1 cm
Number of Pages: 464 Pages
Language: English
Publication Name: Predictive Modeling of Pharmaceutical Unit Operations
Publisher: Elsevier Science & Technology
Publication Year: 2016
Subject: Medicine, Business
Item Height: 229 mm
Item Weight: 860 g
Type: Textbook
Author: Preetanshu Pandey, Rahul Bharadwaj
Item Width: 152 mm
Format: Hardcover