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Leachables and Extractables Handbook - Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products
Language
English
English
Book
Hardback
Because leachables are non-drug-related impurities, there are increased concerns regarding the risks...
Full description
Libristo code: 04881708
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417 b
417 b
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Because leachables are non-drug-related impurities, there are increased concerns regarding the risks of inhaling them on a daily basis. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed. This book also illustrates how to apply these concepts and principles to products beyond OINDP, and includes an appendix of experimental protocols for laboratory analysis.
About the book
Full name
Leachables and Extractables Handbook - Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products
Author
Douglas J. Ball
Language
English
English
Binding
Book - Hardback
Date of issue
2012
Number of pages
700
EAN
9780470173657
ISBN
0470173653
Libristo code
04881708
Publishers
John Wiley & Sons Inc
Weight
1116
Dimensions
157 x 241 x 43
