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

Name: Leachables and Extractables Handbook - Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products
Brand: John Wiley & Sons Inc
SKU: 9780470173657
Price: 3325 CZK
Availability: InStock

Autor: Douglas J. Ball

Jazyk:

Vazba: Pevná

Vydavatel: John Wiley & Sons Inc

Dostupnost: Skladem u dodavatele

Odesíláme za 14-21 dnů

3 325 Kč

Because leachables are non-drug-related impurities, there are increased concerns regarding the risks...

Informace o knize

Autor

Douglas J. Ball

Jazyk

Angličtina

Vazba

Kniha - Pevná

Vydáno

2012

Stránek

700

EAN

9780470173657

ISBN

0470173653

Enbook ID

04881708

Vydavatel

John Wiley & Sons Inc

Hmotnost

1116

Rozměry

157 x 241 x 43

Kompletní popis

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

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