Defining Long-Term Stability Testing Periods Based on Shelf Life and Regulatory Guidance
Defining Long-Term Stability Testing Periods Based on Shelf Life and Regulatory Guidance Establishing Long-Term Stability Testing Durations Based on Shelf Life and Regulatory Expectations Long-term stability testing is the cornerstone of pharmaceutical shelf life determination. It provides critical evidence that a drug product will remain within specification throughout its marketed storage period. The duration, frequency,…