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,…
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 stabil…