Title:
Extractables and leachables : characterization of drug products, packaging, manufacturing and delivery systems, and medical devices
Author:
Jenke, Dennis, author.
ISBN:
9781119605102
9781119605096
9781119605089
Physical Description:
1 online resource (xvi, 431 pages) : illustrations (chiefly color)
Contents:
INTRODUCTION AND ESSENTIAL CONCEPTS -- GENERAL PRINCIPLES OF CHEMICAL ASSESSMENT; EXTRACTION AND LEACHING -- GENERAL PRINCIPLES OF CHEMICAL ASSESSMENT; ANALYTICAL TESTING FOR EXTRACTABLES AND LEACHABLES; ORGANIC COMPOUNDS -- GENERAL PRINCIPLES OF CHEMICAL ASSESSMENT; ANALYTICAL TESTING FOR EXTRACTABLES AND LEACHABLES; ELEMENTS, ANIONS AND GENERAL TESTING -- EXTRACTABLES, LEACHABLES AND THE PRODUCT LIFECYCLE THROUCH PRODUCT APPROVAL AND LAUNCH -- EXTRACTABLES, LEACHABLES AND THE PRODUCT LIFECYCLE, CHANGE CONTROL -- APPLICATIONS -- PHARMACUETICAL DRUG PRODUCTS -- PACKAGING -- APPLICATIONS -- PHARMACEUTICAL DRUG PRODUCTS -- MANUFACTURING COMPONENTS AND SYSTEMS -- APPLICATIONS -- MEDICAL DEVICES -- GENERAL PRINCIPLES FOR RISK ASSESSMENT OF EXTRACTABLES AND LEACHABLES -- FOCUS ON EMERGING CONCEPTS -- GLOSSARY AND ABBREVIATION.
Abstract:
"This book addresses the safety aspects of compatibility for drugs and their delivery devices and containers -- dealing with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. Although essential tenets and principles are relevant and useful today as 10 years ago, the E&L landscape has changed dramatically. In the book, the author covers new and forthcoming regulations and best practices, economic need to quickly develop and commercialize safe and affordable clinical therapies, and looking at the diversity of products / materials / and applications on an individual or case basis rather than in general terms"-- Provided by publisher.
Local Note:
John Wiley and Sons
Subject Term:
Genre:
Electronic Access:
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119605096Copies:
Available:*
Library | Material Type | Item Barcode | Shelf Number | Status | Item Holds |
|---|---|---|---|---|---|
Searching... | E-Book | 597573-1001 | RS159 .J46 2022 | Searching... | Searching... |