Автор: Jens T. Carstensen and Christopher Rhodes
Название: Drug Stability: Principles and Practices, 3rd Edition
Издательство: CRC Press
Год: 2000
ISBN: 978-8123915876
Серия: Drugs and the Pharmaceutical Sciences (Book 107)
Язык: English
Формат: pdf
Размер: 28,8 mb
Страниц: 792

Everything made by human hands—from the sublime Parthenon to the trivial milkshake—is subject to decay. Pharmaceuticals are no exception to this general statement. If there is any functionally relevant quality attribute of a drug product that changes with time, evaluation of this change falls within the purview of the pharmaceutical scientists and regulators who quantify drug product stability and shelf life.

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.