Forced Degradation Data Management in Drug Development

Introduction

Forced degradation studies are critical for first developing stability indicating methods and then characterizing degradants. A stability indicating method is a chromatographic method used to validate analytical procedures. It measures the active pharmaceutical ingredient (API) in a drug substance or drug product. Once these methods are developed, they are applied to measuring the byproducts formed during stress testing.

Stability indicating method development and degradant characterization are aided by understanding the process scheme and efficient inter-department communication. Teams are often spread across multiple locations and use different electronic systems to capture information, which impedes coordination. As a result, teams resort to unspecialized programs such as Microsoft Excel or PowerPoint to share data.

While easily accessible, these applications are not built to handle complex scientific data. They lack chemical intelligence, cannot process analytical data and are not suitable for collaborative workflows.