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Könyv Leachables and Extractables Handbook - Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products Douglas J. Ball

Leachables and Extractables Handbook - Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products

Szerző: Douglas J. Ball
Nyelv: Angol
Kötés: Kemény kötésű
Kiadó: John Wiley & Sons Inc
Elérhetőség: Beszállítói készleten
Küldés 14-21 napon belül
55 601 Ft
Because leachables are non-drug-related impurities, there are increased concerns regarding the risks...

Információk a könyvről

Szerző
Douglas J. Ball
Nyelv
Angol
Kötés
Könyv - Kemény kötésű
Kiadva
2012
oldal
700
EAN
9780470173657
ISBN
0470173653
Enbook ID
04881708
Kiadó
John Wiley & Sons Inc
Súly
1116
Méretek
157 x 241 x 43

Teljes leírás

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.

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