Near-patient stability studies.
Approaches to performing stability tests on formulations developed in hospitals, defined as the near-patient situation, are reviewed. Emphasis is placed on the selection and validation of storage conditions and the statistical methodology necessary to ensure confidence in the results obtained.
Barnes
A R
AR
Pharmaceutical Sciences Institute, Aston University, Birmingham, U.K.
D004355:Drug Stability; D004356:Drug Storage; D008027:Light; D019095:Point-of-Care Systems; D012034:Refrigeration / Q000379:methods*; D012044:Regression Analysis; D013696:Temperature