Predictive modeling of pharmaceutical unit operations. (Record no. 7306)
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000 -LEADER | |
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fixed length control field | 02115nam a22001697a 4500 |
003 - CONTROL NUMBER IDENTIFIER | |
control field | OSt |
005 - DATE AND TIME OF LATEST TRANSACTION | |
control field | 20211018122003.0 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
fixed length control field | 211018b ||||| |||| 00| 0 eng d |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
International Standard Book Number | 9780081001547 |
060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
Classification number | QV 779 PP 2017 |
100 ## - MAIN ENTRY--PERSONAL NAME | |
Personal name | Pandey, Preetanshu. |
245 ## - TITLE STATEMENT | |
Title | Predictive modeling of pharmaceutical unit operations. |
260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
Place of publication, distribution, etc. | New Delhi : |
Name of publisher, distributor, etc. | woodhead publishing, |
Date of publication, distribution, etc. | 2017. |
300 ## - PHYSICAL DESCRIPTION | |
Extent | xi, 437 p. : |
Other physical details | ill. ; |
Dimensions | 25 cm. |
520 ## - SUMMARY, ETC. | |
Summary, etc. | 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.<br/><br/>Explains the commonly used modeling and simulation tools<br/>Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing<br/>Practical examples of the application of modeling tools through case studies<br/>Discussion of modeling techniques used for a risk-based approach to regulatory filings<br/>Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points |
942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
Source of classification or shelving scheme | National Library of Medicine Classification |
Koha item type | Books |
Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Date acquired | Total Checkouts | Full call number | Barcode | Date last seen | Price effective from | Koha item type |
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National Library of Medicine Classification | FNPH LIBRARY | FNPH LIBRARY | 18/10/2021 | QV 779 PP 2017 | 13154 | 18/10/2021 | 18/10/2021 | Books |