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.
New Drug Approval Process, 5th Edition Автор: Richard A. Guarino and Richard Guarino Название: New Drug Approval Process, 5th Edition Издательство: CRC Press Год: 2009 ISBN: 9781420088496;...
New Drug Approval Process Автор: Richard A Guarino Название: New Drug Approval Process Издательство: CRC Press Год: 1999 Серия: Drugs and the Pharmaceutical Sciences (Book...