Have more confidence in your stability data: two points to consider.
Simple statistical, mathematical, and chemical arguments are presented that will justify performing all stability studies using a different approach than is currently practiced in the pharmaceutical and IVD industries. The use of multi time point stability studies is in most cases a waste of resources that could be better spent on endpoint studies at less cost and a significant increase in the quality of the data.
De Vore
Karl
K
Bio-Rad Laboratories, 9500 Jeronimo Road, Irvine, CA 92688, USA. karl_devore@bio-rad.com
D003627:Data Interpretation, Statistical; D004339:Drug Compounding; D004345:Drug Industry / Q000379:methods*; D015233:Models, Statistical; D008962:Models, Theoretical; D012044:Regression Analysis; D015203:Reproducibility of Results; D012189:Retrospective Studies; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D013997:Time Factors