Best Practices for Leachables and Extractables: Parenteral, Ophthalmic and Other Dosage Forms

By Cheryl L M Stults, Daniel L Norwood, Diane M Paskiet

This book provides updated comprehensive information on approaches to the chemical and toxicological evaluation of leachables and extractables in various drug product types, throughout pharmaceutical development and commercial production. It addresses not only safety, but also quality, issues related to both packaging systems and drug products and gives a thorough treatment of other dosage forms - specifically infusion, injectable, and ophthalmic drug products (PODP), including biologics. The authors offer the rationale and development of current approaches to extractables and leachables evaluation for various dosage forms. Discussing the best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle, the book gives readers with practical knowledge about safety thresholds and illustrates how to apply these concepts and principles to pharmaceutical products.

• Format: Hardcover
• Language: English
• ISBN: 1119190428
• ISBN13: 9781119190424
• Release Date: April 2024
• Publisher: Wiley
• Length: 512 Pages
• Weight: 1.47 lbs.