Leachables and Extractables Handbook

Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

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Unknown / Leachables and Extractables Handbook
Genre: books4me > Medical
Format: Book - Hardcover
Released: Tue 24 Jan 2012
Catalogue Number: 0008831533

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Price:  AUD$190.27
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Description:
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.

Details:

  • Editors: Douglas J. Ball, Lee M. Nagao, Daniel L. Norwood, Cherlyl L. M. Stults
  • Publisher: John Wiley & Sons Inc
  • Textual Format: Textbooks, Lower level
  • Academic Level: Professional
  • Depth (m): 0.032
  • Dewey: 615/.6
  • Edition: 1
  • Height (m): 0.229
  • Pages: 683
  • Place Of Publication: United States
  • Published Date: Tue 24 Jan 2012
  • Weight (g): 653
  • Width (m): 0.152

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