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: 620.75 PLN
Availability: InStock

Autor: Douglas J. Ball

Język:

Oprawa: Twarda

Wydawca: John Wiley & Sons Inc

Dostępność: Dostępna u dostawcy

Wysyłamy za 14-21 dni

620.75 zł

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

Informacje o książce

Autor

Douglas J. Ball

Język

Angielski

Oprawa

Książka - Twarda

Data wydania

2012

strony

700

EAN

9780470173657

ISBN

0470173653

Enbook ID

04881708

Wydawca

John Wiley & Sons Inc

Waga

1116

Wymiary

157 x 241 x 43

Pełny opis

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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