Stability studies provide evidence about the quality of a drug product (or drug substance) when subjected to a set of specific environmental conditions (e.g., temperature, humidity, light) over a defined period of time.
These studies are important throughout the development process for a new drug product and can be incorporated within a Quality by Design (“QbD”) approach, providing critical assessments of the stability of the drug substance and aiding the design and development of the drug product formulation and packaging characteristics. Stability studies that satisfy ICH Q1A(R2) conditions can be used to establish appropriate storage conditions and……
Download our PDF to learn more on design and execution of compliant stability studies to support your drug development efforts.
Why Choose Parsolex?
Parsolex offers actively-managed stability study programs with a focus on the client experience. We are committed to fully understanding our clients’ requirements and to delivering each project on agreed upon timelines with high-quality deliverables. Parsolex possesses in-depth experience with the successful execution of stability studies and the application of laboratory test methods for stability testing of pharmaceutical products and a comprehensive understanding of the latest regulatory guidance.
Parsolex offers the following services in support of stability studies:
- Sample storage conditions
- Stability study design and protocol writing
- Stability study management
- Stability testing
- Development and validation of stability-indicating test methods
Contact us today to discuss how we can support your Stability Studies need.