Goals of Stability Studies
The primary goals of stability studies in pharmaceutical development are:
- Assessing Shelf-Life: Determining the period during which a drug product maintains its intended quality, potency, and safety under defined storage conditions.
- Evaluating Product Quality: Monitoring changes in the chemical, physical, and microbiological attributes of a drug over time to ensure compliance with regulatory standards and specifications.
- Identifying Degradation Pathways: Investigating the mechanisms and factors contributing to the degradation of drug substances and products, such as temperature, humidity, light exposure, and pH.
- Optimizing Formulations: Guiding the formulation development process to enhance stability, improve product performance, and minimize degradation risks.
- Supporting Regulatory Requirements: Generating data required for regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and product registrations.
Objectives of Stability Studies
To achieve these goals, stability studies are designed with the following specific objectives:
- Establishing Stability Profiles: Characterizing the stability behavior of drug products by assessing their physical, chemical, and microbiological attributes over time.
- Determining Storage Conditions: Identifying appropriate storage conditions (e.g., temperature, humidity) to maintain product stability throughout its shelf-life.
- Setting Shelf-Life: Establishing expiration dates or retest periods based on stability data to ensure product efficacy, safety, and quality until the end of its shelf-life.
- Investigating Packaging Compatibility: Evaluating the compatibility of drug formulations with packaging materials to prevent interactions that may affect stability.
- Monitoring Changes: Continuously monitoring and analyzing stability data to detect trends, identify critical points, and implement corrective actions as needed.