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: 793.08 RON
Availability: InStock

Autor: Douglas J. Ball

Limbă:

Legare: Copertă tare

Editura: John Wiley & Sons Inc

Disponibilitate: În depozitul extern

Expediem în 14-21 zile

793.08 lei

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

Informații despre carte

Autor

Douglas J. Ball

Limbă

engleză

Legare

Carte - Copertă tare

Publicat

2012

Pagini

700

EAN

9780470173657

ISBN

0470173653

Enbook ID

04881708

Editura

John Wiley & Sons Inc

Greutate

1116

Dimensiuni

157 x 241 x 43

Descriere completă

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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Descriere completă

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