Leachables and Extractables Handbook

preview-18
  • Leachables and Extractables Handbook Book Detail

  • Author : Douglas J. Ball
  • Release Date : 2012-01-24
  • Publisher : John Wiley & Sons
  • Genre : Science
  • Pages : 702
  • ISBN 13 : 0470173653
  • File Size : 6,6 MB

Leachables and Extractables Handbook by Douglas J. Ball PDF Summary

Book Description: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.

Disclaimer: www.yourbookbest.com does not own Leachables and Extractables Handbook books pdf, neither created or scanned. We just provide the link that is already available on the internet, public domain and in Google Drive. If any way it violates the law or has any issues, then kindly mail us via contact us page to request the removal of the link.

Leachables and Extractables Handbook

Leachables and Extractables Handbook

File Size : 6,6 MB
Total View : 6391 Views
DOWNLOAD

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Pac

Extractables and Leachables

Extractables and Leachables

File Size : 12,12 MB
Total View : 2916 Views
DOWNLOAD

EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices a