Drug Stability, Third Edition, Revised, and Expanded

Jens T. Carstensen, Christopher Rhodes

CRC Press

2000

792 páginas

1d 2h 24m

ISBN-13: 9780824703769

Inglês

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.